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Side effects temazepam 15 mg. Temazepam 15mg: Side Effects, Usage, and Safety Precautions

What are the common side effects of temazepam 15mg. How does temazepam affect sleep patterns. What precautions should be taken when using temazepam. When should you seek medical attention while taking temazepam. How does temazepam interact with other medications.

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Understanding Temazepam: Uses and Mechanism of Action

Temazepam, available under the brand name Restoril, is a prescription medication primarily used for the short-term treatment of insomnia. It belongs to a class of drugs called benzodiazepines, which work by enhancing the effects of a neurotransmitter called GABA in the brain. This action helps to calm brain activity and promote sleep.

As a sleep aid, temazepam is typically prescribed for brief periods, usually 7 to 10 days, to help individuals establish a regular sleep pattern. It’s important to note that long-term use can lead to tolerance and dependence, which is why it’s crucial to follow your doctor’s instructions carefully.

How does temazepam differ from other sleep medications?

Unlike some sleep medications that work by altering melatonin levels or targeting specific sleep-wake cycle receptors, temazepam acts as a central nervous system depressant. This means it has a broader calming effect on the brain, which can be beneficial for those experiencing anxiety-related insomnia.

Common Side Effects of Temazepam 15mg

While temazepam can be effective for treating insomnia, it’s essential to be aware of potential side effects. Common side effects occurring in more than 1 in 100 people include:

  • Disturbed sleep (including vivid dreams)
  • Feeling drowsy, tired, or less alert the next day
  • Lightheadedness, unsteadiness, or dizziness
  • Dry mouth

These side effects are generally mild and often subside as your body adjusts to the medication. However, if they persist or worsen, it’s important to consult your healthcare provider.

How can you manage common side effects of temazepam?

To cope with common side effects, consider the following strategies:

  1. For disturbed sleep or vivid dreams, discuss with your doctor about adjusting the dosage or trying a different medication.
  2. If experiencing daytime drowsiness, avoid driving or operating machinery until you feel alert.
  3. For dizziness or unsteadiness, move slowly when changing positions and avoid sudden movements.
  4. To combat dry mouth, stay hydrated, use sugar-free gum or lozenges, and consider using a humidifier at night.

Serious Side Effects and When to Seek Medical Attention

While rare, some individuals may experience serious side effects when taking temazepam. It’s crucial to be aware of these potential reactions and seek immediate medical attention if they occur:

  • Yellowing of the skin or whites of the eyes (jaundice)
  • Difficulty urinating or decreased urine output
  • Noticeable heart palpitations
  • Changes in mood or behavior (e.g., aggression, agitation)
  • Delusions or hallucinations
  • Poor coordination or muscle weakness
  • Slurred speech
  • Memory loss or confusion

If you experience any of these symptoms, contact your healthcare provider immediately or seek emergency medical care.

What are the signs of an allergic reaction to temazepam?

Although rare, temazepam can cause severe allergic reactions. Seek immediate medical attention if you experience:

  • Skin rash (itchy, red, swollen, blistered, or peeling)
  • Wheezing or difficulty breathing
  • Tightness in the chest or throat
  • Swelling of the mouth, face, lips, tongue, or throat

These symptoms may indicate anaphylaxis, a life-threatening allergic reaction requiring immediate treatment.

Temazepam and Sleep Patterns: What to Expect

Temazepam is designed to help individuals fall asleep faster and stay asleep longer. However, it’s essential to understand how it may affect your sleep patterns and overall sleep quality.

How does temazepam influence sleep architecture?

Temazepam primarily affects sleep in the following ways:

  • Reduces sleep onset latency (time it takes to fall asleep)
  • Increases total sleep time
  • May decrease the number of nighttime awakenings
  • Can alter sleep stages, potentially reducing deep sleep (slow-wave sleep) and REM sleep

While temazepam can be effective in improving sleep quantity, it’s important to note that it may not necessarily enhance sleep quality. Some users report feeling groggy or “hungover” the next day, which can be attributed to the drug’s effects on sleep architecture.

Dosage Guidelines and Administration

The typical recommended dose of temazepam for adults is 15mg taken before bedtime. However, dosages can range from 7.5mg to 30mg, depending on individual factors and the severity of insomnia.

How should temazepam be taken for optimal effect?

To maximize the benefits of temazepam while minimizing potential side effects, follow these guidelines:

  1. Take temazepam exactly as prescribed by your doctor
  2. Swallow the capsule whole with a glass of water
  3. Take the medication immediately before going to bed
  4. Ensure you have at least 7-8 hours available for sleep after taking the dose
  5. Avoid alcohol and other central nervous system depressants while using temazepam
  6. Do not exceed the prescribed dose or duration of treatment

It’s crucial to remember that temazepam is intended for short-term use only. Prolonged use can lead to tolerance and dependence.

Precautions and Contraindications

While temazepam can be an effective treatment for insomnia, it’s not suitable for everyone. Certain conditions and factors may increase the risk of adverse effects or contraindicate its use.

Who should avoid taking temazepam?

Temazepam may not be appropriate for individuals with:

  • History of drug or alcohol abuse
  • Severe liver or kidney disease
  • Respiratory conditions such as sleep apnea or COPD
  • Myasthenia gravis
  • Pregnancy or breastfeeding
  • History of depression or suicidal thoughts
  • Allergies to benzodiazepines

Always inform your healthcare provider about your complete medical history and any medications you’re currently taking before starting temazepam.

Drug Interactions and Combination Risks

Temazepam can interact with various medications and substances, potentially leading to increased side effects or reduced efficacy. It’s crucial to be aware of these interactions to ensure safe and effective treatment.

What medications should not be taken with temazepam?

Exercise caution when combining temazepam with the following:

  • Opioid pain medications (e.g., hydrocodone, oxycodone)
  • Other sedatives or sleep aids
  • Antidepressants
  • Antihistamines
  • Antipsychotics
  • Certain antifungal medications
  • Some antibiotics
  • Alcohol

Always consult your healthcare provider or pharmacist before taking any new medications or supplements while using temazepam.

Long-term Effects and Dependency Concerns

While temazepam can be effective for short-term insomnia treatment, long-term use poses significant risks, including tolerance, dependence, and withdrawal symptoms upon discontinuation.

How does long-term temazepam use affect the body and brain?

Extended use of temazepam may lead to:

  • Decreased effectiveness in promoting sleep
  • Cognitive impairment and memory issues
  • Increased risk of falls and accidents, especially in older adults
  • Potential for abuse and addiction
  • Withdrawal symptoms when stopping the medication

If you’ve been using temazepam for an extended period, do not abruptly stop taking it without consulting your healthcare provider. A gradual tapering schedule may be necessary to minimize withdrawal symptoms.

Alternatives to Temazepam for Insomnia Management

While temazepam can be effective for short-term insomnia treatment, there are various alternatives available, both pharmacological and non-pharmacological, that may be suitable for some individuals.

What are some non-pharmacological approaches to managing insomnia?

Consider the following strategies for improving sleep without medication:

  • Cognitive Behavioral Therapy for Insomnia (CBT-I)
  • Sleep hygiene improvements (e.g., consistent sleep schedule, comfortable sleep environment)
  • Relaxation techniques (meditation, deep breathing exercises)
  • Regular exercise (but not too close to bedtime)
  • Limiting caffeine and alcohol intake, especially in the evening
  • Avoiding electronic devices before bedtime

These approaches can be effective in addressing the underlying causes of insomnia and promoting long-term improvements in sleep quality.

Are there other medications for insomnia with different mechanisms of action?

Yes, alternative medications for insomnia include:

  • Non-benzodiazepine hypnotics (e.g., zolpidem, zaleplon)
  • Melatonin receptor agonists (e.g., ramelteon)
  • Orexin receptor antagonists (e.g., suvorexant)
  • Certain antidepressants with sedating properties
  • Over-the-counter sleep aids (e.g., diphenhydramine, doxylamine)

Each of these alternatives has its own set of benefits and potential side effects. Consult with your healthcare provider to determine the most appropriate treatment option for your specific situation.

Monitoring and Follow-up: Ensuring Safe and Effective Use

Regular monitoring and follow-up are essential when using temazepam to ensure its effectiveness and minimize potential risks. Your healthcare provider will likely schedule periodic check-ups to assess your response to the medication and address any concerns.

What should be discussed during follow-up appointments for temazepam use?

During follow-up appointments, be prepared to discuss:

  • Effectiveness of the medication in improving sleep
  • Any side effects experienced
  • Changes in mood or behavior
  • Any new medications or supplements started
  • Plans for discontinuation or alternative treatments

Open communication with your healthcare provider is crucial for optimizing your treatment and ensuring your safety while using temazepam.

How often should temazepam use be reassessed?

The frequency of reassessment may vary depending on individual circumstances, but generally:

  • Initial follow-up within 1-2 weeks of starting treatment
  • Regular check-ins every 4-6 weeks during ongoing treatment
  • Immediate consultation if experiencing severe side effects or concerns

Remember, temazepam is intended for short-term use, typically not exceeding 4 weeks. Your healthcare provider will work with you to develop a plan for safely discontinuing the medication when appropriate.

By staying informed about the potential side effects, proper usage, and important precautions associated with temazepam, you can work closely with your healthcare provider to manage your insomnia effectively and safely. Always follow your prescribed treatment plan and don’t hesitate to ask questions or voice concerns about your medication regimen.

Side effects of temazepam – NHS

Like all medicines, temazepam can cause side effects, although not everyone gets them.

Common side effects

These common side effects of temazepam happen in more than 1 in 100 people. There are things you can do to help cope with them:

Disturbed sleep (such as vivid dreams)

Your doctor may suggest a different medicine or a lower dose.

Feeling drowsy, tired, less alert or “hungover” the next day

Try to lie down or sit down until it passes. Do not drive, ride a bike, or use tools or machinery until you feel OK. If the symptoms do not disappear after a few days or get worse, talk to your doctor.

Feeling lightheaded, unsteady or dizzy

Your doctor may suggest a lower dose. Do not drive, ride a bike or use machinery until you feel better.

A dry mouth

If this bothers you, try taking sips of water and keep some water by your bed at night. Using a mouthwash before bedtime may also help. Ask your pharmacist to recommend one that’s good for a dry mouth, as some can make a dry mouth worse.

Speak to a doctor or pharmacist if the advice on how to cope does not help and a side effect is still bothering you or does not go away.

Serious side effects

It happens rarely, but some people have serious side effects when taking temazepam.

Tell a doctor or contact 111 straight away if you get any of the following side effects:

  • the whites of your eyes turn yellow, or your skin turns yellow although this may be less obvious on brown or black skin (jaundice) – this can be a sign of liver problems
  • difficulty peeing or peeing less than usual
  • noticeable heartbeats (palpitations)
  • changes in the way you feel or act, such as feeling numb or restless, agitated or aggressive or acting inappropriately
  • you think things that are not true (delusions) or you see or hear things that are not there (hallucinations)
  • poor co-ordination or weak muscles
  • slurred speech
  • memory loss or confusion

Go to 111. nhs.uk or call 111.

Serious allergic reaction

In rare cases, temazepam may cause a serious allergic reaction (anaphylaxis).

Immediate action required: Call 999 or go to A&E now if:

  • you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
  • you’re wheezing
  • you get tightness in the chest or throat
  • you have trouble breathing or talking
  • your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

Other side effects

These are not all the side effects of temazepam. For a full list, see the leaflet inside your medicine packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 3 February 2022

Next review due: 3 February 2025

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.

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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.

Description of TEMAZEPAM indications, dosages, contraindications of the active substance TEMAZEPAM

Rec.INN
WHO registered


drug interaction

Pharmacological action

Anxiolytic agent (tranquilizer) from the group of benzodiazepine derivatives. Eliminates the state of tension, fear, anxiety, increased excitability, irritation.

Pharmacokinetics

Temazepam is rapidly and almost completely absorbed from the gastrointestinal tract. C max is reached in 1-2 hours and is 669-982 ng/ml. Plasma protein binding – 96%. Penetrates through the BBB, the placental barrier, into breast milk. C ss is noted after 1-3 days of treatment. It is metabolized in the liver by direct binding to glucuronic acid to form inactive metabolites. Removal is carried out in 2 phases: T 1/2 in the first phase is 0.4-0.6 hours, in the second – 3.5-18.4 hours. 80-90% is excreted by the kidneys, the rest is with feces. Cumulation upon repeated administration is minimal (applies to benzodiazepines with a short and medium T 1/2 ).

Indications of the active substance
TEMAZEPAM

Neuroses and psychopathy accompanied by anxiety, fear, emotional stress, depressive and hypochondriacal syndrome, neurasthenia, involutional depression.

Open list of ICD-10 codes

F32 Depressive episode
F40 Phobic anxiety disorders (including agoraphobia, social phobias)
F41. 2 Mixed anxiety and depressive disorder
F41.9 Anxiety disorder, unspecified
F45.2 Hypochondriacal disorder
F48.0 Neurasthenia
F48.9 Neurotic disorder, unspecified
R45.1 Anxiety and agitation

Dosage regimen

Inside 10 mg 3 times / day. If necessary, the dose can be increased to 20 mg 3 times / day.

Side effects

From the side of the central nervous system and peripheral nervous system: at the beginning of treatment (especially in elderly patients) – drowsiness, dizziness, fatigue, impaired concentration, ataxia, disorientation, unsteadiness of gait and poor coordination of movements, lethargy, dulling of emotions, slowing down of mental and motor reactions; rarely – headache, euphoria, depression, tremor, depressed mood, numbness, memory impairment (including anterograde amnesia), confusion, dystonic extrapyramidal reactions (uncontrolled body movements, including the eyes), weakness, muscle weakness during the day , dysarthria, blurred speech; extremely rarely – paradoxical reactions (aggressive outbursts, psychomotor agitation, fear, suicidal tendencies, muscle spasm, confusion, hallucinations, acute agitation, irritability, anxiety, insomnia).

From the side of the cardiovascular system: decrease in blood pressure; rarely – tachycardia.

From the hematopoietic system: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, unusual fatigue or weakness), anemia, thrombocytopenia.

From the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, anorexia, constipation, diarrhea, abnormal liver function, increased activity of liver transaminases and alkaline phosphatase, jaundice.

From the urinary system: urinary incontinence, urinary retention, impaired renal function.

From the reproductive system: increase or decrease in libido, dysmenorrhea.

Allergic reactions: skin rash, itching.

Other: addiction, drug dependence; rarely – depression of the respiratory center, visual impairment (diplopia), bulimia, weight loss.

With a sharp dose reduction or discontinuation: withdrawal syndrome (irritability, headache, anxiety, excitement, agitation, fear, nervousness, sleep disturbance, dysphoria, spasm of smooth muscles of internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, including hyperacusis, paresthesia, photophobia, tachycardia, convulsions, hallucinations, rarely acute psychosis).

Contraindications for use

Coma, shock, acute alcohol intoxication with impaired vital functions, acute intoxication with drugs that have a depressant effect on the central nervous system (narcotics, hypnotics and psychotropic drugs), myasthenia gravis, angle-closure glaucoma (acute attack or predisposition), severe COPD (progression of the degree of respiratory failure), acute respiratory failure, severe depression (suicidal tendencies may occur), pregnancy, lactation (breastfeeding), children and adolescents under 18 years of age (safety and efficacy have not been determined), hypersensitivity to temazepam.

Use in pregnancy and lactation

Temazepam is contraindicated in pregnancy and lactation (breastfeeding).

Effect on the fetus: teratogenicity (especially in the first trimester), CNS depression, respiratory failure and suppression of the sucking reflex in newborns whose mothers used temazepam.

Use in hepatic impairment

Use with caution in patients with hepatic impairment.

Use in impaired renal function

Use with caution in patients with renal insufficiency.

Use in children

Contraindicated in children and adolescents under 18 years of age (safety and efficacy not determined).

Use in the elderly

Use with caution in elderly patients.

Precautions

Precautions should be given to patients with hepatic and / or renal insufficiency, cerebral and spinal ataxias, hyperkinesia, drug dependence in history, a tendency to abuse psychotropic drugs, organic brain diseases, psychosis (possible paradoxical reactions), hypoproteinemia , sleep apnea (established or suspected), elderly patients.

Alcohol should not be consumed during treatment with the drug.

Influence on the ability to drive vehicles and mechanisms

Patients taking temazepam should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Drug interactions

With the simultaneous use of drugs that have a depressant effect on the central nervous system, it is possible to increase the inhibitory effect on the central nervous system.

With the simultaneous use of oral contraceptives, the effectiveness of temazepam is reduced.

A case of development of the toxic effect of temazepam (drowsiness, confusion) with simultaneous use with disulfiram is described.

Memorial Sloan Kettering Cancer Center

Adult Medication

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This document, provided by Lexicomp ® , contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Restoril

Trade names: Canada

Restoril

Warning

  • This drug is a benzodiazepine. The use of benzodiazepines concomitantly with opioids resulted in very severe side effects. Observed side effects have included slowing or difficulty in breathing, as well as death. Opioids include drugs such as codeine, oxycodone, and morphine. Opioids are used to treat pain, and some are used to treat coughs. Consult your doctor.
  • If you are taking this drug with an opioid, get medical help right away if you feel very drowsy or dizzy, if you have slow, shallow, or difficult breathing, or if you pass out. Caregivers or others should seek immediate medical attention if the patient does not respond, does not respond, or does not respond in the usual way, or if he sleeps and does not wake up.
  • There may be a risk of dependence, abuse or misuse when using benzodiazepines. Misuse or abuse of this drug may result in overdose or death, especially when used along with certain other drugs, alcohol, or drugs. Dependence may occur even if you use this drug as your doctor has told you to. Seek immediate medical attention if you have changes in mood or behavior, suicidal thoughts or actions, seizures, or trouble breathing.
  • You will be closely monitored to avoid misuse, abuse, or dependence on this drug.
  • Benzodiazepines can be addictive. Dose reduction or abrupt discontinuation of this drug may cause withdrawal symptoms. This can be life threatening. The risk of dependence and withdrawal increases with long-term use of this drug or when taking it in high doses. Talk to your doctor before reducing your dose or stopping this drug. You must follow the doctor’s instructions. Seek medical attention right away if you have trouble controlling your body movements, have seizures, have or become more severe, behavior or mood changes such as depression or thoughts of suicide, thoughts of hurting someone, hallucinations (seeing or hearing non-existent things), loss of contact with reality, erratic movements or conversations, or any other side effects.
  • Sometimes withdrawal symptoms can last from a few weeks to more than 12 months. Tell your doctor if you have any concerns; problems with memory, learning, or concentration; sleep problems; burning, numbness, or tingling; weakness; tremor; muscle twitching; ringing in the ears or any other side effects.

What is this drug used for?

  • It is used to treat sleep disorders.

What should I tell my doctor BEFORE taking this drug?

  • If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.
  • If you are taking other drugs that make you drowsy. There are many drugs that can have this effect. If you are not sure, ask your doctor or pharmacist for advice.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Tell your doctor and pharmacist about all medicines you take (both prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

  • Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
  • If sleeping pills are used every night for more than a few weeks, their effectiveness may decrease. The so-called tolerance to the drug develops. Do not take sleeping pills for a long period of time. If you have insomnia for a long period, consult your doctor.
  • After taking this drug, avoid driving, or other activities or activities that require increased attention. You may feel sleepy the day after taking this drug. Avoid such activities or activities until you are completely awake.
  • To reduce the risk of dizziness or loss of consciousness, get up slowly from a lying or sitting position. Walking up and down stairs should be done with care.
  • Avoid drinking alcohol while taking this drug. Do not take this drug if you drank alcohol that night or before bed.
  • Check with your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that can slow you down.
  • This drug may cause drowsiness and reduce concentration. These effects can lead to crashes. The risk of falls is higher in the elderly. If you have any questions, please consult your doctor.
  • If you are 65 years of age or older, use this drug with caution. You may experience more side effects.
  • When used during pregnancy, the drug may have a harmful effect on the fetus. If you are pregnant or become pregnant while taking this drug, call your doctor right away.
  • Taking this drug late in pregnancy may increase the risk of breathing or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Consult with your doctor.
  • If you are breastfeeding or planning to breastfeed, tell your doctor. This drug passes into breast milk and may harm your baby.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Call your doctor right away or get medical help if you have any of the following signs or symptoms that could be associated with serious side effects:

  • Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
  • The onset or worsening of behavioral or emotional disorders, such as depression or suicidal thoughts.
  • Hallucinations (a person sees or hears something that is not in reality).
  • Impairment or loss of memory.
  • Confusion of consciousness.
  • Lack of clarity of thought.
  • Balance change.
  • Severe dizziness or fainting.
  • Severe nausea or vomiting.
  • Some people, while not fully awake, engaged in certain activities and performed various tasks, such as driving a car, cooking, eating, and having sex. In most cases, people do not remember that they did these actions. If this happens to you, check with your doctor.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Contact your doctor or seek medical attention if these or any other side effects bother you or do not go away:

  • Headache.
  • Dizziness.
  • Sleepiness the next day.
  • Feeling tired or weak.
  • Nausea.
  • Nervous tension and agitation.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

  • Take this drug with or without food.
  • Take this drug immediately before going to bed.
  • Do not take this drug if you are unable to get a good night’s sleep (for at least 7 to 8 hours) before you need to be active again.
  • If you still have trouble sleeping after 7-10 days, contact your doctor.

What if I miss a dose of a drug?

  • If you are taking the drug regularly, take the missed dose as soon as you can.
  • If you are unable to get adequate sleep (for at least 7 hours) after taking the missed dose, skip the missed dose and then return to your regular dosing schedule.
  • Do not take 2 doses or an additional dose at the same time.
  • In most cases, this drug is used as needed. Do not take the drug more often than prescribed by your doctor.

How do I store and/or discard this drug?

  • Store at room temperature in a dry place. Do not store in the bathroom.
  • Keep this medicine in a protected place out of sight and reach of children and out of the reach of other people. A box or room that is locked with a key can act as a secure storage place for the drug. Keep all medicines out of the reach of pets.
  • Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General drug information

  • If your health does not improve or even worsens, see your doctor.
  • Do not give your medicine to anyone and do not take other people’s medicines.
  • Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
  • A separate instruction for patients is attached to the drug. Please read this information carefully. Reread it each time you refill your supply. If you have any questions about this drug, ask your doctor, pharmacist, or other health care professional.
  • If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient.