What are the side effects of temazepam 15mg. How is temazepam used for insomnia. What is the recommended dosage for temazepam. What are the FDA warnings for temazepam. How does temazepam work in the body.

Understanding Temazepam: A Benzodiazepine for Insomnia Treatment

Temazepam, available under the brand name Restoril, is a prescription medication belonging to the benzodiazepine class of drugs. It is primarily used for the short-term treatment of insomnia, a common sleep disorder characterized by difficulty falling asleep or maintaining sleep throughout the night. As a controlled substance, temazepam requires careful management and monitoring due to its potential for misuse and dependence.

How Does Temazepam Work?

Temazepam exerts its effects by enhancing the action of gamma-aminobutyric acid (GABA), a neurotransmitter in the brain. GABA is responsible for reducing neuronal excitability, which promotes relaxation and sleep. By amplifying GABA’s effects, temazepam helps to induce drowsiness and improve sleep quality.

FDA Warnings and Safety Concerns Associated with Temazepam

The U.S. Food and Drug Administration (FDA) has issued several important warnings regarding the use of temazepam. These boxed warnings highlight potential risks that healthcare providers and patients should be aware of:

• Increased risk of suicidal thoughts and behavior, particularly in children, adolescents, and young adults
• Dangerous effects when used in combination with opioid medications
• Potential for physical dependence and withdrawal reactions
• Risk of misuse and addiction

Is temazepam safe for long-term use? Temazepam is generally recommended for short-term use only, typically not exceeding 7-10 days. Prolonged use can lead to tolerance, dependence, and increased risk of adverse effects. Patients should work closely with their healthcare provider to determine the appropriate duration of treatment.

Common Side Effects of Temazepam 15mg

While temazepam can be effective for managing insomnia, it may cause various side effects. The most common side effects associated with temazepam 15mg include:

• Drowsiness
• Headache
• Tiredness
• Nervousness
• Dizziness
• Nausea

These side effects are typically mild and may subside as the body adjusts to the medication. However, if they persist or worsen, it is important to consult a healthcare provider.

Serious Side Effects and Precautions

While less common, temazepam can potentially cause serious side effects that require immediate medical attention. These may include:

• Severe allergic reactions (anaphylaxis)
• Abnormal thoughts and behaviors
• Severe drowsiness and impairment the following day
• Withdrawal symptoms upon abrupt discontinuation

Can temazepam cause memory problems? Some users may experience anterograde amnesia, a condition where they have difficulty forming new memories while under the influence of the medication. This side effect underscores the importance of taking temazepam only when able to dedicate a full night to sleep.

Proper Dosage and Administration of Temazepam

Temazepam is available as an oral capsule and should be taken as prescribed by a healthcare provider. The typical recommended dosage for adults with insomnia is 15mg taken before bedtime. However, dosages may vary based on individual factors such as age, overall health, and response to treatment.

Dosage Considerations

• Elderly patients or those with compromised liver function may be prescribed lower doses
• The maximum recommended dose is 30mg
• Temazepam should be taken only when able to dedicate 7-8 hours to sleep

How long does it take for temazepam to work? Temazepam typically begins to take effect within 30 minutes to an hour after ingestion. Users should plan to take the medication immediately before going to bed to minimize the risk of engaging in activities while not fully alert.

Interactions and Contraindications

Temazepam can interact with various substances and medications, potentially altering its effectiveness or increasing the risk of adverse effects. It is crucial to inform your healthcare provider about all medications, supplements, and substances you are using before starting temazepam treatment.

Notable Interactions

• Opioid medications
• Alcohol
• Other central nervous system depressants
• Certain antifungal medications
• Some antibiotics

Is it safe to drink alcohol while taking temazepam? Combining alcohol with temazepam can dangerously enhance the sedative effects of both substances, potentially leading to severe drowsiness, respiratory depression, and other serious complications. It is strongly advised to avoid alcohol consumption while using temazepam.

Managing Insomnia: Temazepam and Beyond

While temazepam can be an effective short-term solution for insomnia, it is essential to consider it as part of a comprehensive approach to sleep management. Cognitive-behavioral therapy for insomnia (CBT-I), lifestyle modifications, and sleep hygiene practices can offer long-term benefits without the risks associated with prolonged medication use.

Non-Pharmacological Approaches to Improving Sleep

• Establishing a consistent sleep schedule
• Creating a relaxing bedtime routine
• Optimizing the sleep environment
• Limiting exposure to screens before bedtime
• Regular exercise (but not too close to bedtime)
• Stress management techniques

Can lifestyle changes be as effective as medication for treating insomnia? For many individuals, implementing good sleep hygiene practices and addressing underlying factors contributing to insomnia can be highly effective. These approaches often provide sustainable improvements in sleep quality without the potential risks associated with sleep medications.

Withdrawal and Discontinuation of Temazepam

Abruptly stopping temazepam after regular use can lead to withdrawal symptoms, which can be uncomfortable and potentially dangerous. The severity of withdrawal symptoms often depends on the duration of use and the dosage.

Common Withdrawal Symptoms

• Rebound insomnia
• Anxiety
• Irritability
• Tremors
• Sweating
• In severe cases, seizures

How should temazepam be discontinued safely? To minimize the risk of withdrawal symptoms, temazepam should be tapered gradually under the guidance of a healthcare provider. This typically involves slowly reducing the dosage over time, allowing the body to adjust to decreasing levels of the medication.

Special Considerations for Temazepam Use

Certain populations may require additional precautions or modifications when using temazepam:

Elderly Patients

Older adults may be more sensitive to the effects of temazepam and at higher risk for falls and cognitive impairment. Lower doses are often recommended for this population.

Pregnancy and Breastfeeding

Temazepam is generally not recommended during pregnancy or while breastfeeding due to potential risks to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss alternative options with their healthcare provider.

Patients with Respiratory Conditions

Individuals with respiratory disorders, such as sleep apnea or COPD, may be at increased risk of respiratory depression when using temazepam. Close monitoring and potential dose adjustments may be necessary.

Is temazepam suitable for everyone with insomnia? While temazepam can be effective for many individuals, it is not appropriate for everyone. Factors such as medical history, current medications, and the underlying cause of insomnia all play a role in determining the most suitable treatment approach. A thorough evaluation by a healthcare provider is essential to determine if temazepam is the right choice for an individual’s specific situation.

Long-Term Considerations and Alternatives to Temazepam

Given the potential risks associated with long-term benzodiazepine use, it’s important to consider temazepam as a short-term solution while exploring sustainable approaches to managing insomnia. Healthcare providers may recommend alternative treatments for chronic insomnia, including:

• Non-benzodiazepine sleep medications (e.g., zolpidem, eszopiclone)
• Melatonin receptor agonists
• Certain antidepressants with sedating properties
• Over-the-counter sleep aids
• Herbal supplements (e.g., valerian root, chamomile)

Are there natural alternatives to temazepam for improving sleep? Many individuals find relief from insomnia through natural remedies and lifestyle changes. These may include practicing relaxation techniques, using essential oils, maintaining a consistent sleep schedule, and addressing underlying issues such as stress or anxiety. While these approaches may not work for everyone, they offer potential benefits without the risks associated with prescription sleep medications.

Monitoring and Follow-up Care for Temazepam Users

Regular follow-up with a healthcare provider is crucial for individuals using temazepam. This allows for ongoing assessment of the medication’s effectiveness, monitoring for side effects, and adjusting the treatment plan as needed. During these follow-up appointments, healthcare providers may:

• Evaluate sleep patterns and overall sleep quality
• Assess for signs of dependence or tolerance
• Discuss any side effects or concerns
• Consider alternative treatments or tapering strategies
• Provide guidance on sleep hygiene and non-pharmacological approaches

How often should patients follow up with their doctor while taking temazepam? The frequency of follow-up appointments may vary based on individual circumstances, but typically, patients should have an initial follow-up within the first few weeks of starting temazepam. Subsequent appointments may be scheduled monthly or as determined necessary by the healthcare provider to ensure safe and effective use of the medication.

Patient Education and Empowerment

Empowering patients with knowledge about temazepam and insomnia management is crucial for safe and effective treatment. Key points to emphasize include:

• The importance of adhering to prescribed dosages and treatment duration
• Recognizing and reporting potential side effects
• Understanding the risks of combining temazepam with alcohol or other substances
• Implementing good sleep hygiene practices
• The benefits of a holistic approach to managing insomnia

How can patients actively participate in their insomnia treatment? Patients can take an active role in their treatment by keeping a sleep diary, openly communicating with their healthcare provider about their experiences and concerns, and actively engaging in recommended lifestyle modifications and sleep hygiene practices. This collaborative approach can lead to more personalized and effective insomnia management.

Temazepam in the Context of Overall Sleep Health

While temazepam can provide short-term relief from insomnia, it’s essential to view it as part of a broader approach to sleep health. Addressing underlying factors contributing to sleep difficulties, such as stress, anxiety, or poor sleep habits, can lead to more sustainable improvements in sleep quality.

Integrating Temazepam with Comprehensive Sleep Management

• Combining medication with cognitive-behavioral therapy for insomnia (CBT-I)
• Gradually transitioning from medication to non-pharmacological approaches
• Regular reassessment of sleep patterns and treatment effectiveness
• Exploring the root causes of insomnia and addressing them directly

Can temazepam be part of a long-term sleep management strategy? While temazepam is typically recommended for short-term use, some individuals may benefit from intermittent or as-needed use under close medical supervision. However, the focus should be on developing sustainable sleep habits and addressing underlying issues to reduce reliance on sleep medications over time.

Side Effects, Dosage, Uses, and More

Highlights for temazepam

1. Temazepam oral capsule is available as a brand-name drug and a generic drug. Brand name: Restoril.
2. Temazepam comes only as a capsule you take by mouth.
3. Temazepam is used for the short-term treatment of insomnia (trouble sleeping).

FDA warnings

• This drug has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.
• Suicidal thinking and behavior warning: This drug can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults. This is more likely to happen during the first few months of treatment with this drug. When you or your child first starts taking this drug, your doctor and family should watch closely. They should look for changes in behavior or worsening signs of depression.
• Dangerous effects with opioid use: Using this drug with opioid drugs, such as hydrocodone, or codeine, can cause dangerous effects. Your risk is higher if you take high doses of either drug and take them for a long time. Call your doctor or 911 right away if you or someone you’re caring for has symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. These symptoms can lead to coma and even death.
• Physical dependence and withdrawal reactions: Taking this medication for several days to weeks can cause physical dependence and withdrawal reactions. Do not suddenly stop taking this medication without talking with your doctor. If you suddenly stop taking this medication, you may have withdrawal symptoms, which can be life threatening.
• Misuse and addiction: Taking this medication can lead to misuse and addiction. This can increase your risk of overdose and death.

Was this helpful?

Other warnings

• Abnormal thoughts and behavior warning: Temazepam can cause abnormal thoughts and behaviors. Some people, while taking this drug have driven, prepared and eaten food, made phone calls, or had sex at times when they were not completely conscious. Call your doctor immediately if you develop any of these symptoms.
• Severe allergic reaction warning: This drug can cause a severe allergic reaction. Call 911 or go to the emergency room right away if you have swelling of your face, tongue, or throat or you have trouble breathing. A severe allergic reaction may cause death. You shouldn’t take this medication again if you’ve ever had an allergic reaction to it.
• Severe drowsiness warning: Even if you take temazepam as prescribed, you may still have severe drowsiness and impairment the next day. You shouldn’t drive or do other activities for which you need to be alert until you feel fully awake.
• Withdrawal warning: You may have withdrawal symptoms if you stop taking temazepam suddenly. Withdrawal symptoms can be serious and include seizures, shakiness, stomach and muscle cramps, vomiting, and sweating. Mild withdrawal symptoms can include depressed mood and trouble sleeping. Talk to your doctor before you stop taking this drug.

Temazepam comes as a capsule you take by mouth. This drug is a controlled substance. It can be misused, and its use can lead to dependence.

Temazepam is available as the brand-name drug Restoril. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Temazepam may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it’s used

Temazepam is used for the short-term treatment of insomnia. This is a sleep problem that includes trouble falling asleep as well as waking up often during the night.

How it works

Temazepam belongs to a class of drugs called benzodiazepines. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Temazepam works by increasing the action of a substance in your body called gamma aminobutyric acid (GABA). GABA sends signals through your nervous system that can improve sleep. When you take temazepam, the effects of GABA are increased in your body.

Temazepam oral capsule causes drowsiness. It can also cause other side effects.

More common side effects

The more common side effects of temazepam can include:

• drowsiness
• headache
• tiredness
• nervousness
• dizziness
• nausea

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Doing things while not completely conscious or with no memory of it occurring, such as:
  • eating
  • talking
  • having sex
  • driving a car
  • sleepwalking
• Abnormal thoughts and behavior. Symptoms can include:
  • behavior that is more outgoing and aggressive than normal
  • confusion
  • agitation
  • hallucinations
  • worsened depression
  • suicidal thoughts or actions
• Anxiety
• Severe allergic reaction. Symptoms can include:
  • swelling of the tongue or throat
  • trouble breathing
  • nausea
  • vomiting

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Temazepam oral capsule can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor and pharmacist about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

Examples of drugs that can cause interactions with temazepam are listed below.

Interactions that increase your risk of side effects

Taking temazepam with certain drugs increases your risk of side effects, such as drowsiness. Examples of these drugs include:

• Phenothiazines, such as chlorpromazine, fluphenazine, promethazine, and thioridazine
• Barbiturates, such as amobarbital, butabarbital, and pentobarbital
• Sedatives or hypnotics, such as eszopiclone, zaleplon, and zolpidem
• Anxiolytics, such as alprazolam, clonazepam, lorazepam, midazolam, and triazolam
• Sedative antihistamines, such as brompheniramine, chlorpheniramine, dimenhydrinate, diphenhydramine, and doxylamine
• Anesthetics, such as etomidate, propofol, and ketamine
• Antidepressants, such as fluvoxamine, fluoxetine, and nefazodone
• Narcotic analgesics, such as buprenorphine, codeine, dihydrocodeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, tapentadol, and tramadol

Taking temazepam with certain drugs puts you at serious risk of severe drowsiness, slowed breathing, coma, or death. These drugs include:

• Opioids, such as morphine, hydrocodone, oxycodone, and codeine

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

Temazepam can cause a severe allergic reaction. Symptoms can include:

• swelling of your tongue or throat
• trouble breathing
• nausea
• vomiting

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Drowsiness warning

Temazepam oral capsule causes drowsiness and may cause dizziness. You should not take temazepam unless you are able to stay in bed and get a full night’s sleep (7–8 hours) before you must be active again. This drug should be taken right before you get in bed.

Alcohol interaction warning

The use of drinks that contain alcohol can increase your risk of side effects such as drowsiness, sleepiness, confusion, and doing activities in your sleep without knowing. Do not take temazepam if you drink alcohol.

Warnings for people with depression

If you have been diagnosed with depression, you may be at an increased risk of worsening depression and suicidal thoughts while you take this drug. Your doctor should prescribe the lowest dosage necessary to help you with your sleep problems.

Warnings for other groups

For pregnant women: Temazepam is a category X pregnancy drug. Category X drugs should never be used during pregnancy. Women of childbearing age should use reliable birth control while taking this drug.

For women who are breastfeeding: It isn’t known whether temazepam is passed in breast milk. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: As you age, your body processes drugs more slowly. Because of that, it’s recommended that your maximum starting dosage of temazepam be 7.5 mg once per day, immediately before bedtime.

For children: This medication hasn’t been studied in children. It shouldn’t be used in children younger than 18 years.

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• the severity of your condition
• other medical conditions you have
• how you react to the first dose

Dosage for insomnia

Generic: Temazepam

• Form: oral capsule
• Strengths: 7. 5 mg, 15 mg, 22.5 mg, 30 mg

Brand: Restoril

• Form: oral capsule
• Strengths: 7.5 mg, 15 mg, 22.5 mg, 30 mg

Adult dosage (ages 18–64 years)

• The typical starting dosage is 15 mg per day, taken right before bedtime.
• Your dosage may range between 7.5 mg per day and 30 mg per day.

Child dosage (ages 0–17 years)

It hasn’t been confirmed that temazepam is safe and effective for use in children younger than 18 years.

Senior dosage (ages 65 years and older)

The typical dosage is 7.5 mg per day, taken right before bedtime.

Dosage warning

Taking a dosage higher than what your doctor prescribed increases your risk of extreme drowsiness.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Temazepam oral capsule is used for short-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: If you don’t take temazepam at all, your sleep problems may not get better. If you suddenly stop taking temazepam, you may experience withdrawal. Symptoms of withdrawal can include:

• seizures
• shakiness
• stomach or muscle cramps
• vomiting
• sweating

If you miss doses or don’t take the drug on schedule: If you miss a dose, you may not sleep as well as you would if you took the drug. This drug should be taken immediately before bedtime. If you take it too early, you may feel sleepy before your bedtime. If you take the medication too late, your risk of drowsiness the next morning increases.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms can range from excessive drowsiness to coma.

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you don’t take your medication right before bedtime and remember to take it with less than 7 or 8 hours left to sleep, don’t take the medication.

How to tell if the drug is working: You should see an improvement in your ability to fall asleep and stay asleep.

Keep these considerations in mind if your doctor prescribes temazepam for you.

General

Take temazepam immediately before bedtime.

Storage

• Store temazepam at a temperature between 68°F and 77°F (20°C and 25°C).
• Keep this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Side Effects, Dosage, Uses, and More

Highlights for temazepam

1. Temazepam oral capsule is available as a brand-name drug and a generic drug. Brand name: Restoril.
2. Temazepam comes only as a capsule you take by mouth.
3. Temazepam is used for the short-term treatment of insomnia (trouble sleeping).

FDA warnings

• This drug has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.
• Suicidal thinking and behavior warning: This drug can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults. This is more likely to happen during the first few months of treatment with this drug. When you or your child first starts taking this drug, your doctor and family should watch closely. They should look for changes in behavior or worsening signs of depression.
• Dangerous effects with opioid use: Using this drug with opioid drugs, such as hydrocodone, or codeine, can cause dangerous effects. Your risk is higher if you take high doses of either drug and take them for a long time. Call your doctor or 911 right away if you or someone you’re caring for has symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. These symptoms can lead to coma and even death.
• Physical dependence and withdrawal reactions: Taking this medication for several days to weeks can cause physical dependence and withdrawal reactions. Do not suddenly stop taking this medication without talking with your doctor. If you suddenly stop taking this medication, you may have withdrawal symptoms, which can be life threatening.
• Misuse and addiction: Taking this medication can lead to misuse and addiction. This can increase your risk of overdose and death.

Was this helpful?

Other warnings

• Abnormal thoughts and behavior warning: Temazepam can cause abnormal thoughts and behaviors. Some people, while taking this drug have driven, prepared and eaten food, made phone calls, or had sex at times when they were not completely conscious. Call your doctor immediately if you develop any of these symptoms.
• Severe allergic reaction warning: This drug can cause a severe allergic reaction. Call 911 or go to the emergency room right away if you have swelling of your face, tongue, or throat or you have trouble breathing. A severe allergic reaction may cause death. You shouldn’t take this medication again if you’ve ever had an allergic reaction to it.
• Severe drowsiness warning: Even if you take temazepam as prescribed, you may still have severe drowsiness and impairment the next day. You shouldn’t drive or do other activities for which you need to be alert until you feel fully awake.
• Withdrawal warning: You may have withdrawal symptoms if you stop taking temazepam suddenly. Withdrawal symptoms can be serious and include seizures, shakiness, stomach and muscle cramps, vomiting, and sweating. Mild withdrawal symptoms can include depressed mood and trouble sleeping. Talk to your doctor before you stop taking this drug.

Temazepam comes as a capsule you take by mouth. This drug is a controlled substance. It can be misused, and its use can lead to dependence.

Temazepam is available as the brand-name drug Restoril. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Temazepam may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it’s used

Temazepam is used for the short-term treatment of insomnia. This is a sleep problem that includes trouble falling asleep as well as waking up often during the night.

How it works

Temazepam belongs to a class of drugs called benzodiazepines. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Temazepam works by increasing the action of a substance in your body called gamma aminobutyric acid (GABA). GABA sends signals through your nervous system that can improve sleep. When you take temazepam, the effects of GABA are increased in your body.

Temazepam oral capsule causes drowsiness. It can also cause other side effects.

More common side effects

The more common side effects of temazepam can include:

• drowsiness
• headache
• tiredness
• nervousness
• dizziness
• nausea

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Doing things while not completely conscious or with no memory of it occurring, such as:
  • eating
  • talking
  • having sex
  • driving a car
  • sleepwalking
• Abnormal thoughts and behavior. Symptoms can include:
  • behavior that is more outgoing and aggressive than normal
  • confusion
  • agitation
  • hallucinations
  • worsened depression
  • suicidal thoughts or actions
• Anxiety
• Severe allergic reaction. Symptoms can include:
  • swelling of the tongue or throat
  • trouble breathing
  • nausea
  • vomiting

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Temazepam oral capsule can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor and pharmacist about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

Examples of drugs that can cause interactions with temazepam are listed below.

Interactions that increase your risk of side effects

Taking temazepam with certain drugs increases your risk of side effects, such as drowsiness. Examples of these drugs include:

• Phenothiazines, such as chlorpromazine, fluphenazine, promethazine, and thioridazine
• Barbiturates, such as amobarbital, butabarbital, and pentobarbital
• Sedatives or hypnotics, such as eszopiclone, zaleplon, and zolpidem
• Anxiolytics, such as alprazolam, clonazepam, lorazepam, midazolam, and triazolam
• Sedative antihistamines, such as brompheniramine, chlorpheniramine, dimenhydrinate, diphenhydramine, and doxylamine
• Anesthetics, such as etomidate, propofol, and ketamine
• Antidepressants, such as fluvoxamine, fluoxetine, and nefazodone
• Narcotic analgesics, such as buprenorphine, codeine, dihydrocodeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, tapentadol, and tramadol

Taking temazepam with certain drugs puts you at serious risk of severe drowsiness, slowed breathing, coma, or death. These drugs include:

• Opioids, such as morphine, hydrocodone, oxycodone, and codeine

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

Temazepam can cause a severe allergic reaction. Symptoms can include:

• swelling of your tongue or throat
• trouble breathing
• nausea
• vomiting

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Drowsiness warning

Temazepam oral capsule causes drowsiness and may cause dizziness. You should not take temazepam unless you are able to stay in bed and get a full night’s sleep (7–8 hours) before you must be active again. This drug should be taken right before you get in bed.

Alcohol interaction warning

The use of drinks that contain alcohol can increase your risk of side effects such as drowsiness, sleepiness, confusion, and doing activities in your sleep without knowing. Do not take temazepam if you drink alcohol.

Warnings for people with depression

If you have been diagnosed with depression, you may be at an increased risk of worsening depression and suicidal thoughts while you take this drug. Your doctor should prescribe the lowest dosage necessary to help you with your sleep problems.

Warnings for other groups

For pregnant women: Temazepam is a category X pregnancy drug. Category X drugs should never be used during pregnancy. Women of childbearing age should use reliable birth control while taking this drug.

For women who are breastfeeding: It isn’t known whether temazepam is passed in breast milk. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: As you age, your body processes drugs more slowly. Because of that, it’s recommended that your maximum starting dosage of temazepam be 7.5 mg once per day, immediately before bedtime.

For children: This medication hasn’t been studied in children. It shouldn’t be used in children younger than 18 years.

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• the severity of your condition
• other medical conditions you have
• how you react to the first dose

Dosage for insomnia

Generic: Temazepam

• Form: oral capsule
• Strengths: 7. 5 mg, 15 mg, 22.5 mg, 30 mg

Brand: Restoril

• Form: oral capsule
• Strengths: 7.5 mg, 15 mg, 22.5 mg, 30 mg

Adult dosage (ages 18–64 years)

• The typical starting dosage is 15 mg per day, taken right before bedtime.
• Your dosage may range between 7.5 mg per day and 30 mg per day.

Child dosage (ages 0–17 years)

It hasn’t been confirmed that temazepam is safe and effective for use in children younger than 18 years.

Senior dosage (ages 65 years and older)

The typical dosage is 7.5 mg per day, taken right before bedtime.

Dosage warning

Taking a dosage higher than what your doctor prescribed increases your risk of extreme drowsiness.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Temazepam oral capsule is used for short-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: If you don’t take temazepam at all, your sleep problems may not get better. If you suddenly stop taking temazepam, you may experience withdrawal. Symptoms of withdrawal can include:

• seizures
• shakiness
• stomach or muscle cramps
• vomiting
• sweating

If you miss doses or don’t take the drug on schedule: If you miss a dose, you may not sleep as well as you would if you took the drug. This drug should be taken immediately before bedtime. If you take it too early, you may feel sleepy before your bedtime. If you take the medication too late, your risk of drowsiness the next morning increases.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms can range from excessive drowsiness to coma.

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you don’t take your medication right before bedtime and remember to take it with less than 7 or 8 hours left to sleep, don’t take the medication.

How to tell if the drug is working: You should see an improvement in your ability to fall asleep and stay asleep.

Keep these considerations in mind if your doctor prescribes temazepam for you.

General

Take temazepam immediately before bedtime.

Storage

• Store temazepam at a temperature between 68°F and 77°F (20°C and 25°C).
• Keep this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Instructions for use of phenazepam: rules of administration and dosage

Contents

• 1 Instructions for the use of phenazepam: dosage, side effects and contraindications
  • 1.1 Preparation Phenazepam: description and features
    • 1.1.1 Description of the preparation
    • 1.1.2 Features
  • 1.2 Phenazepam dosage
    • 1.2.1 Usual dosage
    • 1.2.2 Dosage for the elderly
    • 1.2.3 Dosage for children
    • 1.2.4 Overdose
  • 1.3 Indications for the use of phenazepam
  • 1.4 Contraindications for the use of phenazepam
    • 1.4.1 Alcohol intoxication

    900 05 1.4.2 Hypersensitivity to the active substance

    • 1.4.3 Pregnancy and lactation
    • 1.4 .4 Increased glaucoma
    • 1.4.5 Serious impairment of liver and kidney function
  • 1.5 Possible side effects of phenazepam
  • 1.6 Rules for taking phenazepam
    • 1.6.1 Dosage
    • 1. 6.2 How to use
    • 1.6.3 Duration of treatment
    • 1.6.4 Side effects
  • 1.7 How to take phenazepam at bedtime
  • 1.8 Phenazepam withdrawal policy
    • 1.8.1 Consult with doctor
    • 1.8.2 Monitor your condition
  • 1.9 Considerations for the use of phenazepam in the elderly
  • 1.10 Interactions with other drugs
  • 1.11 How to store phenazepam
  • 1.12 Related videos:
  • 1.13 Q&A:
    • • 1.13.0.1 What is phenazepam used for?
      • 1.13.0.2 How to take phenazepam?
      • 1.13.0.3 What side effects can occur when taking phenazepam?
      • 1.13.0.4 How long does phenazepam last?
      • 1.13.0.5 Can phenazepam be taken during pregnancy and lactation?
      • 1.13.0.6 Is phenazepam a drug?

Learn all about the instructions for Phenazepam: how to take the medicine, what doses are safe and how to avoid side effects. In our article you will find detailed information on the use of phenazepam for the treatment of anxiety, neuroses and seizures. Proven advice from experts will help you use the drug with maximum benefit and minimal risk.

Phenazepam is a drug that belongs to the class of benzodiazepine tranquilizers and anxiolytics. It is used to treat neurotic conditions, insomnia, mental and neurological diseases, adjustment disorders and other conditions.

The drug has a sedative, anxiolytic, sedative and muscle relaxant effect. It reduces anxiety, improves mood, relieves tension, promotes muscle relaxation, and improves sleep quality.

Despite the wide spectrum of activity and effectiveness of phenazepam, its use requires compliance with certain recommendations and restrictions. The instructions for use provide a detailed description of the dosage, regimen and duration of administration, possible side effects and contraindications to the use of this drug.

In this article, we will look at the main points that need to be considered when using phenazepam in order to achieve maximum effect and avoid negative health consequences.

Phenazepam: description and features

Description of the drug

Phenazepam is a drug used as a sedative and anxiolytic agent. The drug is a benzodiazepine and has an effect on the central nervous system. Phenazepam can reduce anxiety, normalize sleep and reduce the manifestations of muscle tension.

Due to its specific formula that affects GABA receptors, Phenazepam has a calming effect, reduces anxiety and stress, and also has a short tranquilizing effect.

Features of the drug

• Dosage : when using Phenazepam, it is important to follow the recommended dosage prescribed by the neurologist. The drug should be taken strictly according to the prescription of a specialist.
• Presence of side effects : Phenazepam can cause negative reactions of the body in the form of drowsiness, dizziness, insomnia, car ataxia. If these symptoms are severe, you should consult a doctor and reconsider the dosage.
• Contraindications : the drug is contraindicated in case of individual intolerance, liver and kidney diseases, pregnancy. It is also necessary to limit the use of Phenazepam in the presence of allergic reactions to benzodiazepines.
• Storage rules : Phenazepam should be stored in a dry place, at a temperature not exceeding 25 degrees Celsius.

Phenazepam dosage

Usual dosage

For the treatment of anxiety and insomnia, a dosage of phenazepam in the range of 0.5 to 1 mg, 2-3 times a day is usually used. The maximum dose should not exceed 10 mg per day.

These doses may be increased depending on the severity of the condition and the individual characteristics of the patient, but only under strict medical supervision.

Dosage for the elderly

In the elderly, metabolism may be slowed down, so it is recommended to start treatment with a minimum dose of 0.25 mg per day. A further increase in the dose should be carried out only in the absence of side effects and under the supervision of a physician.

Dosage for children

Phenazepam is not recommended for use in children under 18 years of age. If the use of this drug is necessary, the dosage should be determined by the attending physician and strictly observed.

Overdose

An overdose of phenazepam can lead to unwanted side effects such as drowsiness, dizziness, lowering blood pressure, slow heart rate.

In case of an overdose, an ambulance should be called immediately and arrangements should be made to treat the patient in the hospital.

Indications for the use of phenazepam

Phenazepam is a psychotropic drug used for various mental disorders. The main indications for its use are:

1. Anxiety and fear syndromes. Phenazepam relieves anxiety, improves mood and reduces manifestations of fear. It is effective in disorders such as panic attacks, general anxiety, social phobia.
2. Depression of the central nervous system. Phenazepam is able to have a sedative effect, suppress anxiety, pain and normalize sleep. It is used for neurosis, neuritis, nightmares.
3. Epilepsy. Phenazepam is one of the drugs that can be used for epilepsy. It has a specific anticonvulsant effect, which reduces the frequency and severity of convulsive seizures in patients.
4. Muscle spasms. Phenazepam exhibits a muscle-relaxing effect, which allows it to be used in spastic conditions of the muscular system. It is widely used for muscle spasms, osteochondrosis, radiculitis, trauma and other conditions.
5. Alcohol syndrome. Phenazepam may be used in the treatment of alcohol syndrome. It reduces the symptoms of poisoning, hastens withdrawal symptoms, and helps prevent delirium or other complications.

Contraindications to the use of phenazepam

Alcohol intoxication

It is highly undesirable to take phenazepam in a state of alcoholic intoxication, as this can lead to an increase in the depressive effect on the central nervous system and additional suppression of breathing and cardiac activity.

Hypersensitivity to the active substance

If a patient has an allergic reaction to phenazepam or other side effects have been noticed while using it, then further use of this drug is unacceptable.

Pregnancy and lactation

Phenazepam may cause harm to the developing fetus and pass into breast milk, so its use during pregnancy or lactation should be carried out with caution and only on strict medical grounds.

Increased glaucoma

The use of phenazepam may lead to deterioration of visual function in patients who suffer from increased glaucoma.

Serious disorders of the liver and kidneys

In severe pathologies of the digestive and urinary systems, phenazepam can accumulate in the body and cause an increasing toxic effect.

Possible side effects of phenazepam

Phenazepam is a powerful sedative drug that can cause various side effects. Some of them can be serious and require immediate medical attention.

• Drowsiness: One of the most common side effects of phenazepam is drowsiness. This effect can be dangerous when working with machinery or driving a car.
• Decreased blood pressure: phenazepam may cause a decrease in blood pressure, which may lead to dizziness and unconsciousness. If these symptoms occur, you should immediately consult a doctor.
• Breath-holding: Phenazepam may cause breath-holding in some patients. This effect is very serious and can lead to death. If you are having difficulty breathing, call an ambulance immediately.
• Irritability and aggressiveness: Phenazepam may cause mood changes such as irritability and aggressiveness.
• Increased appetite and weight gain: Phenazepam may cause increased appetite and weight gain in some patients.

In addition, phenazepam can cause side effects such as headache, nausea, vomiting, constipation, diarrhea, memory loss and depression. If you experience any unusual or serious side effects while taking phenazepam, contact your doctor immediately.

Rules for taking phenazepam

Dosage

The dosage of phenazepam should be prescribed by the doctor in accordance with the patient’s condition and the severity of his disease. Usually the initial dose is 0.25-0.5 mg 2-3 times a day. The dose may be increased to 4 mg per day.

Route of administration

Phenazepam should be taken orally after meals. The tablet should be taken with a sufficient amount of water. It is necessary to observe the regularity of reception and not to skip doses.

Duration of treatment

The duration of the use of phenazepam is determined by the doctor and depends on the severity of the disease, the age of the patient and the condition of his body. Typically, treatment lasts at least 2 weeks and no more than 4 months. When extending the course of treatment, it is necessary to pass tests for liver function.

Side effects

• drowsiness;
• dizziness;
• weakness;
• decreased concentration;
• alarm;
• irritability;
• allergic skin reactions.

If you experience side effects, you should consult a doctor so that he can adjust the dosage or change the drug to another one.

How to take phenazepam before bed

Your doctor may recommend taking phenazepam before bed to improve sleep quality. In order for the dosage to be correct and safe for your health, follow the doctor’s recommendations and instructions for use of the drug.

Phenazepam is best taken at bedtime, 30-40 minutes before bedtime. The drug has a sedative effect, so it is not recommended to take it before driving a car or doing other activities that require increased concentration.

Take phenazepam at the exact dosage recommended by your doctor. Do not stop taking the drug without his permission, as this can lead to excellent symptomatic effect and negative consequences for your health.

Rules for stopping Phenazepam

Talk to your doctor

Before you stop taking Phenazepam, be sure to consult your doctor. He will help you plan your withdrawal process properly and tell you what medications you can take instead.

How do I stop taking?

It is necessary to stop taking Phenazepam gradually, gradually reducing the dosage. Never stop taking a medicine abruptly, as this can cause serious health problems.

Monitor your condition

Be sure to monitor your health during the Phenazepam withdrawal process. If you feel a strong change in your condition, contact your doctor.

Never take more medicine

If you are not sure how to take your medicine or something is unclear, never take more medicine. It is better to ask your doctor or pharmacist for advice.

Calculate the time to cancel

Do not forget that the process of canceling Phenazepam may take a short time. Calculate in advance the necessary time and plan your affairs taking this factor into account.

Features of the use of phenazepam in elderly patients

When using phenazepam in the elderly, it is necessary to take into account the age characteristics of the body and possible concomitant diseases. The dosage and regimen of taking the drug should be selected individually for each patient, based on his state of health.

It is also worth considering the possible interactions of phenazepam with other drugs that an elderly patient may take at the same time. For example, the combination of phenazepam with hypnotics or narcotic analgesics can lead to increased sedation and the onset of respiratory failure.

• Recommendations for the use of phenazepam in the elderly:
• start at the lowest dose
• gradually increase the dosage while monitoring patient response
• avoid combination with other sedatives
• consult a physician if you have comorbid conditions or other medications

Interactions with other drugs

Phenazepam may interact with other drugs, which can lead to unexpected effects m and poor health patient. Interactions between phenazepam and other drugs should be carefully studied before taking phenazepam in combination with other drugs.

Phenazepam should not be taken concomitantly with sedatives, antidepressants, tranquilizers and certain types of antibiotics, as this may worsen the effect of phenazepam and lead to a strong negative effect on health.

If you are taking other medicines, be sure to tell your doctor about this so that he can determine the possible interaction and adjust the dose of phenazepam.

If you are already taking other medicines, be sure to check with your doctor before taking phenazepam to avoid possible negative effects and deterioration of your health.

How to store phenazepam

Keep out of the reach of children.

Phenazepam should be stored in a safe place where children cannot get to it. The ideal place for storage is a closed cabinet or drawer that can be padlocked.

Store between 15 and 30 degrees Celsius.

Phenazepam must be stored at a certain temperature to maintain its quality. The recommended temperature is from 15 to 30 degrees Celsius. Do not store phenazepam in the refrigerator.

Keep in original packaging.

Phenazepam must be stored in the original packaging. This packaging is designed to protect the tablets from light, humidity and other external adverse factors. Tablets should not be removed from packaging prior to use.

Avoid exposure to direct sunlight.

Phenazepam should not be stored in direct sunlight on the packaging of tablets. The sun can damage the tablets, which will lead to a change in their quality. Storage in a shady place or in a dark closet will help to avoid this problem.

Related videos:

Q&A:

What is phenazepam used for?

Phenazepam is used as a sedative, anxiolytic and muscle relaxant drug. It eliminates anxiety, tension and skeletal muscle spasms, and improves the quality of sleep.

How to take phenazepam?

The dose and duration of use of phenazepam is prescribed by a doctor. Usually the drug is taken orally after a meal, drinking plenty of water. Do not exceed the recommended dose and duration of use without consulting your doctor.

What side effects can occur when taking phenazepam?

Phenazepam may cause side effects such as drowsiness, decreased concentration, dizziness, muscle weakness, changes in blood pressure, intestinal disorders, etc. If you experience unwanted effects, you should consult your doctor.

How long does phenazepam last?

The duration of action of phenazepam is about 6-8 hours. However, the individual rate of metabolism and excretion from the body can affect the duration of the drug.

Can phenazepam be taken during pregnancy and breastfeeding?

Phenazepam is contraindicated in pregnancy and lactation. The drug can have a toxic effect on the fetus and adversely affect the development of the baby.

Is phenazepam a drug?

No, phenazepam is not a drug. However, the drug is a strong psychotropic drug and can cause mental and physical dependence if used excessively and incorrectly.

Sibazon ІС: instruction, price, analogues | tablets InterChem

• Pharmacological properties
• Indications Sibazon ІС
• Application Sibazon ІС
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Storage conditions
• Diagnosis
• Recommended alternatives
• Trade names

pharmacodynamics . Diazepam is one of the main benzodiazepine tranquilizers. It has an anxiolytic, central muscle relaxant, anticonvulsant, sedative and moderate hypnotic effect. Shows little vegetative activity.

The mechanism of action of Sibazon IC is associated with GABA, which is an inhibitory neurotransmitter in the CNS. It is known that GABAergic neurons inhibit the activity of neurons of other types. The drug reduces the activity of the GABA transaminase enzyme, thereby increasing the content of GABA in the brain. On the other hand, the sensitivity of membranes to GABA increases. All this enhances the inhibitory effect of GABAergic neurons on neurons of other types. Inhibition of noradrenergic and dopaminergic neurons is responsible for the sedative and hypnotic effects of Sibazone IC and other benzodiazepines. The anticonvulsant and muscle relaxant effect is due to the inhibition of the corresponding neurons of the cortical centers and the spinal cord. Inhibition of excitation processes in the ascending reticular system leads to the development of an anxiolytic effect.

Pharmacokinetics. Absorption . Diazepam is rapidly and completely absorbed in the digestive tract, Cmax _max in plasma is reached 30-90 minutes after oral administration.

Distribution . Diazepam and its metabolites are largely bound to plasma proteins (diazepam – 98%), penetrate the BBB and the placental barrier, and are excreted into breast milk at a concentration that is approximately ¹ / ₁₀ of the concentration of diazepam in the mother’s blood plasma. The volume of distribution is 1–2 l/kg.

Metabolism . Diazepam is predominantly metabolized to pharmacologically active metabolites (N-desmethyldiazepam, temazepam and oxazepam). The oxidative metabolism of diazepam is carried out with the participation of CYP 3A and CYP 2C19 isoenzymes. Subsequently, oxazepam and temazepam are conjugated with glucuronic acid.

Derivation of . After oral administration of the drug, the decrease in the profile of the concentration of diazepam in the blood plasma takes place in 2 phases: the initial phase of rapid distribution is replaced by a prolonged phase of elimination (T _½ – 48 hours). T _½ of the active metabolite of N-desmethyldiazepam can reach 100 hours. Diazepam and its metabolites are excreted mainly in the urine in conjugated forms. The clearance of diazepam is 20–30 ml/min.

Diazepam metabolites may be unchanged up to 2 weeks.

T _½ may be lengthened in newborns, the elderly and patients with impaired liver function. Decreased renal function has no effect on T _½ diazepam.

adults . anxiety disorders. Insomnia (benzodiazepines are indicated only for severe disorders, especially for critically ill patients). Elimination of muscle spasms associated with spasms of cerebral etiology. As part of the complex treatment of epilepsy. Premedication for minor surgical interventions.

for the optimal therapeutic effect, the dose is selected by the doctor individually for each patient. Treatment should begin with the lowest effective dose appropriate for the specific indication.

Tablets to be taken orally.

The duration of treatment with should be as short as possible depending on the indication. In the treatment of insomnia, the duration of the course should not exceed 4 weeks, with anxiety conditions – 8-12 weeks, including a period of gradual dose reduction.

At the start of treatment, inform the patient that the therapy will be of limited duration and explain the tapering schedule. To reduce anxiety due to the occurrence of the rebound phenomenon, the patient must be aware of the possibility of its occurrence during the period of treatment (see SPECIAL INSTRUCTIONS).

It should be borne in mind that when using benzodiazepines with a short duration of action, withdrawal symptoms may occur in the intervals between single doses, especially when using high doses. When using long-acting benzodiazepines, they should not be replaced with short-acting benzodiazepines due to the possibility of developing a withdrawal syndrome.

Adults . The dose is selected by the doctor individually, depending on the patient’s condition.

Alarm conditions . The usual dose for adults is 5 mg/day. The maximum dose is up to 30 mg / day in divided doses. The dosage regimen is set by the doctor individually.

Insomnia associated with anxiety in adults, 5-15 mg at bedtime.

Use the lowest effective dose that eliminates the symptoms of the disease.

Full dose should not be continued for more than 4 weeks.

Long-term use of the drug is not recommended.

Cancellation of the drug should be carried out by gradually reducing the dose. For patients who have used benzodiazepines for a long time, a longer period for dose reduction may be required. The dose can only be reduced by a doctor.

Conditions accompanied by muscle spasms . Muscle spasms: 5–15 mg/day in divided doses.

Spasms of central etiology in selected cases: 2–60 mg/day in divided doses.

Premedication . Adults: 5–20 mg. Children: 2–10 mg.

Benzodiazepines should not be given to children without careful evaluation of indications. The duration of treatment should be kept to a minimum.

hypersensitivity to benzodiazepines or any of the components of the drug. Myasthenia gravis, severe respiratory failure, sleep apnea syndrome, severe liver failure, phobia or obsessive-compulsive disorder, chronic psychosis, alcohol and drug dependence (with the exception of acute withdrawal symptoms).

most often occur fatigue, drowsiness, muscle weakness. In most cases, after a few days of use, they spontaneously disappear. They can also be avoided by reducing the dose of the drug.

From the nervous system: ataxia, dysarthria, speech disturbance, headache, tremor, dizziness, mood deterioration, anger. With an increase in the therapeutic dose of the drug, the risk of anterograde amnesia increases. Amnesic effects may be accompanied by abnormal behavior.

Psychiatric disorders: restlessness, agitation, irritability, aggressiveness, delirium, hostility, nightmares, hallucinations, psychosis, behavioral changes and other adverse behavioral effects (mainly in children and the elderly, if they occur, the drug should be discontinued immediately) , confusion, poverty of emotional manifestations, decreased attention, depression.

Prolonged use of the drug (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of therapy may cause withdrawal or rebound effects.

Abuse of benzodiazepines has been reported (see SPECIAL INSTRUCTIONS).

Injury, poisoning, procedural complications: An increased risk of falls and fractures has been reported with the use of benzodiazepines in elderly patients.

From the digestive tract: nausea, dry mouth or hypersalivation, constipation and other gastrointestinal disorders.

On the part of the organ of vision: diplopia, blurred vision.

From the side of the cardiovascular system: arterial hypotension, circulatory failure, heart failure, including cardiac arrest.

From the urinary system: incontinence or urinary retention.

Skin reactions: skin reactions.

From the side of the organ of hearing: vertigo.

From the respiratory system: respiratory depression, including respiratory failure.

From the hepatobiliary system: very rarely – jaundice.

Other: joint pain, change in libido.

Laboratory indicators: cardiac arrhythmias; very rarely – an increase in the level of transaminases, alkaline phosphatase in the blood.

concomitant use of alcohol/CNS depressants . During treatment with Sibazon ІС, alcohol and / or CNS depressants should not be consumed. This combination enhances the clinical effects of benzodiazepines, including severe sedation, clinically significant respiratory and/or cardiovascular depression.

Sibazon ІС is prescribed with caution to patients with a history of alcohol or drug abuse.

Sibazon ІC is not recommended for patients who are dependent on the use of CNS depressants or alcohol, except for the period of exacerbation of the withdrawal syndrome.

Tolerance . The use of diazepam for several weeks can lead to a weakening of its hypnotic effect due to the development of tolerance.

Dependency . When taking benzodiazepines (even in therapeutic doses), it is possible to develop addiction, the formation of mental and physical dependence. The risk of dependence increases when used in high doses and with an increase in the duration of treatment, as well as in patients with a history of alcohol or drug dependence, personality disorders. Such patients require regular monitoring, re-administration of the drug should be avoided, treatment should be stopped gradually.

Withdrawal syndrome . Sudden discontinuation of benzodiazepines is accompanied by a withdrawal syndrome. Withdrawal syndrome symptoms: headache, muscle pain, increased anxiety, tension, agitation, confusion, irritability. In severe cases, derealization (a disturbance in the perception of the surrounding world), depersonalization, numbness and tingling in the limbs, increased sensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

Recurrence of symptoms of insomnia and anxiety . Abrupt discontinuation of diazepam treatment can provoke a rebound phenomenon, which is manifested by an exacerbation of the condition, followed by a rapid reduction in symptoms (mood changes, anxiety or sleep disturbance, restlessness). To prevent the occurrence of the phenomenon of rebound/withdrawal syndrome, it is recommended to gradually reduce the dose of the drug.

The duration of treatment with should be as short as possible, depending on the indication, but should not exceed 4 weeks for insomnia, 8-12 weeks for anxiety, including a period of gradual dose reduction. The duration of treatment is increased only after a thorough assessment of the patient’s condition.

Patients should be informed about the initiation and duration of treatment and the need for gradual dose reduction should be explained. In addition, the patient should be warned about the possible occurrence of an abstinence syndrome to reduce the severity of anxiety, especially when drug therapy is discontinued.

When using benzodiazepines with a short duration of action, withdrawal symptoms may occur between doses of the drug, especially in the case of a high dose. Due to the risk of withdrawal symptoms, it is not recommended to switch from long-acting benzodiazepines to short-acting benzodiazepines during treatment.

Amnesia . It should be borne in mind that benzodiazepines can cause anterograde amnesia. Anterograde amnesia may occur at therapeutic doses, and the risk increases with higher doses. Amnestic effects may be associated with inappropriate behavior. The condition appears most often within a few hours of taking oral benzodiazepines, so patients should be allowed 7 to 8 hours of uninterrupted sleep to reduce this risk.

Mental and paradoxical reactions . While taking benzodiazepines, reactions such as anxiety, agitation, irritability, aggressiveness, delirium, anger, nightmares, hallucinations, psychosis, inappropriate behavior and other behavioral disorders may occur. In the event of these reactions, it is necessary to stop treatment with the drug. Such reactions are more common in children and the elderly.

Special patient groups . Elderly and debilitated patients require dose reduction (see APPLICATIONS). Due to the muscle relaxant effect, there is a risk of falls and fractures in this group of patients.

Low doses are also recommended in patients with chronic pulmonary insufficiency due to the risk of respiratory depression.

Benzodiazepines are not indicated for the treatment of patients with severe hepatic insufficiency as they may precipitate encephalopathy. Doses should be reduced in patients with chronic liver disease.

In the treatment of patients with impaired renal function, the usual measures should be followed. In renal failure T _½ diazepam does not change, so dose adjustment is not required for these patients.

Benzodiazepines are not recommended for the primary treatment of psychosis.

Benzodiazepines should not be used solely for the treatment of depression or anxiety associated with depression due to the potential for suicidal behavior in such patients.

Benzodiazepines may delay psychological recovery in patients with bereavement symptoms.

During treatment with Sibazon ІC, alcohol is not allowed.

This product contains lactose and should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Use during pregnancy and lactation . Do not use during pregnancy. Diazepam passes into breast milk, so if treatment with the drug is necessary, breastfeeding should be stopped.

If the drug is given to women of childbearing potential, they should tell their doctor to stop treatment if they become pregnant or suspect they are pregnant.

Children . Benzodiazepines should only be given to children when absolutely necessary when other alternative medicines are not available. The duration of treatment should be as short as possible.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms . During treatment, you should refrain from driving vehicles or working with other mechanisms.

interaction pharmacokinetics . The oxidative metabolism of diazepam is carried out with the participation of CYP 3A and CYP 2C19 isoenzymes. Oxazepam and temazepam are further conjugated with glucuronic acid.

Substances that are modulators of CYP 3A and/or CYP 2C19 may alter the pharmacokinetics of diazepam. The drugs cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole inhibit CYP3A and CYP2C19, which can lead to an increase and prolongation of the sedative effect. There is evidence that the metabolic elimination of phenytoin affects the action of diazepam.

Cisapride may cause a transient increase in the sedative effect of oral benzodiazepines due to rapid absorption.

Pharmacodynamics of interaction . An increase in sedative, respiratory and hemodynamic effects may occur with the simultaneous use of diazepam with centrally acting depressants, such as antipsychotics, tranquilizers / sedatives, antidepressants, hypnotics, antiepileptics, narcotic analgesics, anesthetics and sedative antihistamines or alcohol.

Do not drink alcohol during treatment with benzodiazepines.

symptoms: drowsiness, ataxia, dysarthria and nystagmus. An overdose of the drug can rarely cause a threat to life, but can lead to a lack of reflexes, apnea, arterial hypotension, depression of cardio-respiratory activity and coma. The coma usually lasts a few hours but can be prolonged and cyclic, especially in elderly patients. Respiratory depression with benzodiazepines in patients with diseases of the respiratory system has a severe course.

Benzodiazepines potentiate the effects of other CNS antidepressants, including alcohol.

Treatment: monitoring of the basic vital functions of the body. Symptomatic therapy aimed at maintaining the function of the cardiovascular, respiratory systems and central nervous system.

Further absorption can be prevented by taking appropriate medical measures, such as giving activated charcoal for 1-2 hours. If the patient is unconscious, artificial respiration should be given. Gastric lavage is not a common measure for drug excretion. With depression of the nervous system, flumazenil, a benzodiazepine antagonist, is used. This should be done in a hospital setting. Flumazenil has a short T _½ (about 1 hour). Therefore, patients receiving flumazenil require close monitoring after its use. Flumazenil is used with caution when co-administering drugs that lower the seizure threshold (eg, tricyclic antidepressants).

For further information regarding the correct use of flumazenil, read the instructions for use of this drug carefully.

Do not use barbiturates if agitation occurs.

at a temperature not exceeding 25 °C.