Ambien and Ambien CR dosage: Form, strengths, and more

Ambien and Ambien CR (zolpidem) are brand-name prescription medications. The Food and Drug Administration (FDA) has approved Ambien and Ambien CR for use in adults. They’re approved to treat insomnia that involves trouble falling asleep. Ambien CR is also approved to treat insomnia that involves difficulty staying asleep.

Ambien and Ambien CR come as oral tablets. They belong to a class of drugs called sedative-hypnotics. Generic forms of Ambien and Ambien CR are available.

For information about the dosage of Ambien and Ambien CR, including strengths and how to take them, keep reading. For a comprehensive look at Ambien and Ambien CR, see this article.

This article describes typical dosages for Ambien and Ambien CR provided by the drugs’ manufacturer. When taking Ambien or Ambien CR, always follow the dosage prescribed by your doctor.

Below, you’ll find information on Ambien and Ambien CR’s form, strengths, and typical dosages.

Ambien and Ambien CR form

Ambien and Ambien CR come as oral tablets. You’ll take either medication by mouth.

Ambien and Ambien CR strengths

Ambien is available in the following strengths:

• 5 milligrams (mg)
• 10 mg

Ambien CR is available in the following strengths:

• 6.25 mg
• 12.5 mg

Ambien CR is an extended-release form of the drug. Unlike Ambien, it’s released into the body over time rather than all at once.

Typical dosages

Typically, a doctor will start you on a low dosage of Ambien or Ambien CR. If you’re still experiencing insomnia, your doctor may increase the Ambien or Ambien CR dosage strength prescribed. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Doses of this drug should be taken just before bedtime. Plan to have at least 7 to 8 hours available for sleeping after you take a dose.

Ambien dosage for insomnia

Recommended dosages of Ambien vary between males and females.*

The starting Ambien dosage for females is 5 mg once daily. The starting Ambien dosage for males is 5 mg or 10 mg once daily.

If the starting dosage is not effective, your doctor may increase your dosage. A 10-mg dose is the highest dose of Ambien per day that’s typically prescribed.

*Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.

Ambien CR dosage for insomnia

Recommended dosages of Ambien CR also vary between males and females.*

The recommended starting dosage of Ambien CR for females is 6.25 mg once daily. For males, it’s 6.25 mg or 12.5 mg once daily. If the starting dosage is not effective, your doctor may increase your dosage.

A 6.25-mg dose is the lowest dose of Ambien CR per day that’s typically prescribed. A 12.5-mg dose is the highest dose of Ambien CR per day that’s typically recommended.

*Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.

Long-term treatment

Ambien and Ambien CR are not meant to be used as long-term treatments. Instead, they are each used short term to treat insomnia.

If you take more Ambien or Ambien CR than your doctor prescribes, you may develop serious side effects.

It’s important that you do not take more Ambien or Ambien CR than your doctor advises.

Symptoms of an Ambien or Ambien CR overdose

Overdose symptoms for Ambien or Ambien CR can include:

• loss of consciousness
• extreme sleepiness
• breathing problems
• very low blood pressure or heart rate
• coma

In rare cases, an overdose could lead to death.

If you take more than the recommended amount of Ambien or Ambien CR

Call your doctor right away if you believe you’ve taken too much Ambien or Ambien CR. Another option is to call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. If you have severe symptoms, immediately call 911 or your local emergency number, or go to the nearest emergency room.

Below are some frequently asked questions about Ambien and Ambien CR.

What is the maximum Ambien dosage? Is there a ‘normal’ dose of Ambien?

The maximum dosage of Ambien that’s approved by the Food and Drug Administration (FDA) is 10 milligrams (mg), taken once daily. The maximum recommended dosage of Ambien CR is 12.5 mg, taken once daily.

There isn’t a “normal” dose of either drug. However, there are typical recommended doses for both medications. To learn more, see the “Ambien and Ambien CR dosage” section above. Your doctor will prescribe a dosage of Ambien or Ambien CR that’s right for you.

If you have additional questions about dosages for these medications, talk with your doctor or pharmacist.

How do Ambien dosages compare between males and females?

Typically, doctors prescribe a higher dosage of Ambien or Ambien CR to treat insomnia in males compared with females.*

That’s because Ambien’s clearance has a higher rate in males. (Clearance describes how the body processes and removes a drug after a person takes it.)

Ambien’s clearance tends to have a lower rate in females. So, they may need a smaller dose of the drug to have the same effect as males.

If you’d like to learn more about this, ask your doctor or pharmacist.

*Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.

Is there a 2.5-mg dosage of Ambien?

No, this isn’t a recommended dosage of Ambien or Ambien CR. There also isn’t a “low dose” of Ambien for sleep problems. To learn about typical recommended doses for insomnia, see the “Ambien and Ambien CR dosage” section above.

Ambien comes in 5-mg tablets. However, its manufacturer has not stated whether it’s safe to cut the tablets in half.

Ambien CR is an extended-release tablet. It should not be cut, crushed, or chewed. This is because the drug may be released all at once instead of over a period of time as intended.

If you have questions about low doses of Ambien or Ambien CR, ask your doctor or pharmacist.

Does Ambien have an extended-release form and dosage?

Yes, Ambien CR is an extended-release (ER) form of the medication. Unlike Ambien, Ambien CR is released into the body over time rather than all at once.

The recommended Ambien CR dosage is 6.25 mg or 12.5 mg, taken once just before bedtime.

For more information, see the “Ambien and Ambien CR dosage” section above.

The Ambien or Ambien CR dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of insomnia you’re using either medication to treat
• your age
• other medications you may take
• your liver function and other medical conditions

Dosage adjustments

Your doctor may recommend a lower dosage than usual of Ambien or Ambien CR. This may be the case if you’re age 65 years or older or if you have liver problems.

Ambien and Ambien CR come as oral tablets. Unlike Ambien, Ambien CR is released into the body over time rather than all at once.

You’ll take one Ambien tablet or one Ambien CR tablet once daily, just before bedtime. Plan to have at least 7 to 8 hours for sleeping after you take a dose.

Be sure to take Ambien or Ambien CR on an empty stomach. Doing so allows the drug to work quickly, which can help you fall asleep faster. Do not take the tablets with food or right after you’ve eaten.

It may be helpful to take Ambien or Ambien CR at the same time each day, just before going to sleep. This helps you maintain a regular sleep schedule, which may also help the medication work effectively to improve your sleep.

If you have trouble swallowing tablets, see this article for tips on how to take this form of medication. You can also talk with your doctor or pharmacist.

ACCESSIBLE DRUG LABELS AND CONTAINERS

If you’re having trouble reading your prescription label, talk with your doctor or pharmacist. Some pharmacies offer labels with large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist might be able to recommend a pharmacy that does.

If you’re having trouble opening medication bottles, ask your pharmacist about putting Ambien and Ambien CR in an easy-open container. They also may recommend tools that can make it easier to open bottles.

People who’ve misused drugs or alcohol may have a higher risk of misusing or becoming addicted to Ambien or Ambien CR.

Misuse means taking a drug in a way other than how a doctor prescribes it. Addiction means taking a drug even if it’s causing harmful outcomes.

Talk with your doctor if you have concerns about misuse or addiction with Ambien or Ambien CR. Let them know if you’ve misused drugs or alcohol in the past. If your doctor recommends that you take Ambien or Ambien CR, they’ll likely monitor you closely during treatment.

It’s possible to develop dependence on Ambien or Ambien CR. Dependence means your body needs a drug in order to function like usual.

This risk may be greater for people who’ve:

• taken Ambien or Ambien CR long term
• taken higher doses of either drug
• misused drugs or alcohol in the past

Misuse means taking a drug in a way other than how a doctor prescribes it.

Withdrawal symptoms can occur if you stop taking Ambien or Ambien CR abruptly. These are symptoms that can happen when you stop taking a drug your body is dependent on.

Possible withdrawal symptoms for Ambien or Ambien CR can include:

• flushing
• uncontrolled crying
• fatigue
• nausea, vomiting, and stomach cramps
• lightheadedness
• nervousness or panic attacks

Typically, these symptoms go away after a few days.

If you’re interested in stopping Ambien or Ambien CR, talk with your doctor first. They may have you taper your dosage slowly over a few days. This can help decrease possible withdrawal symptoms from the medication.

The dosages presented in this article are typical dosages provided by the drugs’ manufacturer. If your doctor recommends Ambien or Ambien CR for you, they will prescribe the dosage that’s right for you. Always follow the dosage that your doctor prescribes.

As with any drug, never change your dosage of Ambien or Ambien CR without your doctor’s recommendation. If you have questions about the dosage of Ambien or Ambien CR that’s best for you, talk with your doctor.

Besides learning about dosage, you may want other information about Ambien and Ambien CR. These additional articles might be helpful:

• More about Ambien and Ambien CR. For information about other aspects of Ambien and Ambien CR, refer to this article.
• Drug comparison. To find out how Ambien and Ambien CR compare with Lunesta, read this article.
• Interactions. For details about what substances Ambien and Ambien CR interact with, see this article.
• Details about insomnia. For details about your condition, see our science of sleep hub.

Disclaimer: Medical News Today 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 another 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.

Ambien and Ambien CR dosage: Form, strengths, and more

Ambien and Ambien CR (zolpidem) are brand-name prescription medications. The Food and Drug Administration (FDA) has approved Ambien and Ambien CR for use in adults. They’re approved to treat insomnia that involves trouble falling asleep. Ambien CR is also approved to treat insomnia that involves difficulty staying asleep.

Ambien and Ambien CR come as oral tablets. They belong to a class of drugs called sedative-hypnotics. Generic forms of Ambien and Ambien CR are available.

For information about the dosage of Ambien and Ambien CR, including strengths and how to take them, keep reading. For a comprehensive look at Ambien and Ambien CR, see this article.

This article describes typical dosages for Ambien and Ambien CR provided by the drugs’ manufacturer. When taking Ambien or Ambien CR, always follow the dosage prescribed by your doctor.

Below, you’ll find information on Ambien and Ambien CR’s form, strengths, and typical dosages.

Ambien and Ambien CR form

Ambien and Ambien CR come as oral tablets. You’ll take either medication by mouth.

Ambien and Ambien CR strengths

Ambien is available in the following strengths:

• 5 milligrams (mg)
• 10 mg

Ambien CR is available in the following strengths:

• 6.25 mg
• 12.5 mg

Ambien CR is an extended-release form of the drug. Unlike Ambien, it’s released into the body over time rather than all at once.

Typical dosages

Typically, a doctor will start you on a low dosage of Ambien or Ambien CR. If you’re still experiencing insomnia, your doctor may increase the Ambien or Ambien CR dosage strength prescribed. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Doses of this drug should be taken just before bedtime. Plan to have at least 7 to 8 hours available for sleeping after you take a dose.

Ambien dosage for insomnia

Recommended dosages of Ambien vary between males and females.*

The starting Ambien dosage for females is 5 mg once daily. The starting Ambien dosage for males is 5 mg or 10 mg once daily.

If the starting dosage is not effective, your doctor may increase your dosage. A 10-mg dose is the highest dose of Ambien per day that’s typically prescribed.

*Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.

Ambien CR dosage for insomnia

Recommended dosages of Ambien CR also vary between males and females.*

The recommended starting dosage of Ambien CR for females is 6.25 mg once daily. For males, it’s 6.25 mg or 12.5 mg once daily. If the starting dosage is not effective, your doctor may increase your dosage.

A 6.25-mg dose is the lowest dose of Ambien CR per day that’s typically prescribed. A 12.5-mg dose is the highest dose of Ambien CR per day that’s typically recommended.

*Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.

Long-term treatment

Ambien and Ambien CR are not meant to be used as long-term treatments. Instead, they are each used short term to treat insomnia.

If you take more Ambien or Ambien CR than your doctor prescribes, you may develop serious side effects.

It’s important that you do not take more Ambien or Ambien CR than your doctor advises.

Symptoms of an Ambien or Ambien CR overdose

Overdose symptoms for Ambien or Ambien CR can include:

• loss of consciousness
• extreme sleepiness
• breathing problems
• very low blood pressure or heart rate
• coma

In rare cases, an overdose could lead to death.

If you take more than the recommended amount of Ambien or Ambien CR

Call your doctor right away if you believe you’ve taken too much Ambien or Ambien CR. Another option is to call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. If you have severe symptoms, immediately call 911 or your local emergency number, or go to the nearest emergency room.

Below are some frequently asked questions about Ambien and Ambien CR.

What is the maximum Ambien dosage? Is there a ‘normal’ dose of Ambien?

The maximum dosage of Ambien that’s approved by the Food and Drug Administration (FDA) is 10 milligrams (mg), taken once daily. The maximum recommended dosage of Ambien CR is 12.5 mg, taken once daily.

There isn’t a “normal” dose of either drug. However, there are typical recommended doses for both medications. To learn more, see the “Ambien and Ambien CR dosage” section above. Your doctor will prescribe a dosage of Ambien or Ambien CR that’s right for you.

If you have additional questions about dosages for these medications, talk with your doctor or pharmacist.

How do Ambien dosages compare between males and females?

Typically, doctors prescribe a higher dosage of Ambien or Ambien CR to treat insomnia in males compared with females.*

That’s because Ambien’s clearance has a higher rate in males. (Clearance describes how the body processes and removes a drug after a person takes it.)

Ambien’s clearance tends to have a lower rate in females. So, they may need a smaller dose of the drug to have the same effect as males.

If you’d like to learn more about this, ask your doctor or pharmacist.

*Sex and gender exist on spectrums. In this article, use of the terms “male” and “female” refers to sex assigned at birth.

Is there a 2.5-mg dosage of Ambien?

No, this isn’t a recommended dosage of Ambien or Ambien CR. There also isn’t a “low dose” of Ambien for sleep problems. To learn about typical recommended doses for insomnia, see the “Ambien and Ambien CR dosage” section above.

Ambien comes in 5-mg tablets. However, its manufacturer has not stated whether it’s safe to cut the tablets in half.

Ambien CR is an extended-release tablet. It should not be cut, crushed, or chewed. This is because the drug may be released all at once instead of over a period of time as intended.

If you have questions about low doses of Ambien or Ambien CR, ask your doctor or pharmacist.

Does Ambien have an extended-release form and dosage?

Yes, Ambien CR is an extended-release (ER) form of the medication. Unlike Ambien, Ambien CR is released into the body over time rather than all at once.

The recommended Ambien CR dosage is 6.25 mg or 12.5 mg, taken once just before bedtime.

For more information, see the “Ambien and Ambien CR dosage” section above.

The Ambien or Ambien CR dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of insomnia you’re using either medication to treat
• your age
• other medications you may take
• your liver function and other medical conditions

Dosage adjustments

Your doctor may recommend a lower dosage than usual of Ambien or Ambien CR. This may be the case if you’re age 65 years or older or if you have liver problems.

Ambien and Ambien CR come as oral tablets. Unlike Ambien, Ambien CR is released into the body over time rather than all at once.

You’ll take one Ambien tablet or one Ambien CR tablet once daily, just before bedtime. Plan to have at least 7 to 8 hours for sleeping after you take a dose.

Be sure to take Ambien or Ambien CR on an empty stomach. Doing so allows the drug to work quickly, which can help you fall asleep faster. Do not take the tablets with food or right after you’ve eaten.

It may be helpful to take Ambien or Ambien CR at the same time each day, just before going to sleep. This helps you maintain a regular sleep schedule, which may also help the medication work effectively to improve your sleep.

If you have trouble swallowing tablets, see this article for tips on how to take this form of medication. You can also talk with your doctor or pharmacist.

ACCESSIBLE DRUG LABELS AND CONTAINERS

If you’re having trouble reading your prescription label, talk with your doctor or pharmacist. Some pharmacies offer labels with large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist might be able to recommend a pharmacy that does.

If you’re having trouble opening medication bottles, ask your pharmacist about putting Ambien and Ambien CR in an easy-open container. They also may recommend tools that can make it easier to open bottles.

People who’ve misused drugs or alcohol may have a higher risk of misusing or becoming addicted to Ambien or Ambien CR.

Misuse means taking a drug in a way other than how a doctor prescribes it. Addiction means taking a drug even if it’s causing harmful outcomes.

Talk with your doctor if you have concerns about misuse or addiction with Ambien or Ambien CR. Let them know if you’ve misused drugs or alcohol in the past. If your doctor recommends that you take Ambien or Ambien CR, they’ll likely monitor you closely during treatment.

It’s possible to develop dependence on Ambien or Ambien CR. Dependence means your body needs a drug in order to function like usual.

This risk may be greater for people who’ve:

• taken Ambien or Ambien CR long term
• taken higher doses of either drug
• misused drugs or alcohol in the past

Misuse means taking a drug in a way other than how a doctor prescribes it.

Withdrawal symptoms can occur if you stop taking Ambien or Ambien CR abruptly. These are symptoms that can happen when you stop taking a drug your body is dependent on.

Possible withdrawal symptoms for Ambien or Ambien CR can include:

• flushing
• uncontrolled crying
• fatigue
• nausea, vomiting, and stomach cramps
• lightheadedness
• nervousness or panic attacks

Typically, these symptoms go away after a few days.

If you’re interested in stopping Ambien or Ambien CR, talk with your doctor first. They may have you taper your dosage slowly over a few days. This can help decrease possible withdrawal symptoms from the medication.

The dosages presented in this article are typical dosages provided by the drugs’ manufacturer. If your doctor recommends Ambien or Ambien CR for you, they will prescribe the dosage that’s right for you. Always follow the dosage that your doctor prescribes.

As with any drug, never change your dosage of Ambien or Ambien CR without your doctor’s recommendation. If you have questions about the dosage of Ambien or Ambien CR that’s best for you, talk with your doctor.

Besides learning about dosage, you may want other information about Ambien and Ambien CR. These additional articles might be helpful:

• More about Ambien and Ambien CR. For information about other aspects of Ambien and Ambien CR, refer to this article.
• Drug comparison. To find out how Ambien and Ambien CR compare with Lunesta, read this article.
• Interactions. For details about what substances Ambien and Ambien CR interact with, see this article.
• Details about insomnia. For details about your condition, see our science of sleep hub.

Disclaimer: Medical News Today 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 another 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.

Memorial Sloan Kettering Cancer Center

Adult Medication

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Provided by Lexicomp ^® , this document 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

Ambien; Ambien CR; Edluar; Intermezzo [DSC]; Zolpimist [DSC]

Trade names: Canada

APO-Zolpidem ODT; MINT-Zolpidem ODT; PMS-Zolpidem ODT; Sublinox

Warning

• Some people who take this drug do activities such as sleep walking, sleep driving, cook and eat food, have sex, or engage in other activities without fully waking up. In rare cases, this has resulted in serious injury or death. In most cases, these individuals had no memory of having performed these acts. If you experience the above effect, stop taking this drug and tell your doctor immediately.

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 have liver disease.
• If you are taking medicinal or natural preparations as sleeping pills. There are many drugs that are used in connection with sleep disorders. If in doubt, consult your doctor or pharmacist.
• If you have taken this or similar drugs in the past and performed any tasks or activities without ever waking up.
• If you are taking any of these drugs: rifampin or St. John’s wort.

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 (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?

All forms:

• Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• Do not take this drug for longer than the length of time your doctor has prescribed.
• 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.
• Long-term or regular use of this drug may lead to dependence. Sudden discontinuation of this drug may lead to so-called “withdrawal” symptoms. Talk to your doctor before reducing your dose or stopping this drug. You must follow the doctor’s instructions. If you experience any side effects, check with your doctor.
• Don’t take sleep breaks.
• 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.
• If you have phenylketonuria, talk to your doctor. Some foods contain phenylalanine.
• This drug may cause drowsiness or impair alertness. This can lead to falls and injuries that can be very severe. Very severe injuries were noted, such as a fracture of the femoral neck and cerebral hemorrhage. Consult your doctor.
• If you are a woman, use this drug with caution. You may experience more side effects.
• If you are 60 years of age or older, take this drug with caution. You may experience more side effects.
• This drug is not approved for use in children. Children may be at increased risk of side effects such as dizziness and hallucinations. However, your child’s doctor may decide that the benefits of this drug outweigh the risks. Talk to your doctor if you have any questions about the use of this drug in your child.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.
• Taking this drug during the third trimester of pregnancy may cause some health problems in the newborn. Consult your doctor.

Extended release tablets:

• Your alertness may decrease. On the day of taking the drug, refrain from driving vehicles, as well as other activities or activities that require increased attention.

All other dosage forms:

• 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.

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. Contact your doctor or seek medical attention right away if you have any of the following signs or symptoms that may 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).
• Confusion of consciousness.
• Lack of clarity of thought.
• Labored, slow or shallow breathing.
• Balance change.
• Vision change.
• Impairment or loss of memory.
• A very bad reaction called angioedema has happened with this drug. Sometimes this reaction can be life-threatening. Symptoms may include swelling of the hands, face, lips, eyelids, tongue, or throat, difficulty breathing or swallowing, or an uncharacteristic hoarse voice. If any of these symptoms occur, seek medical attention immediately.

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:

• Feeling dizzy, tired or weak.
• Sleepiness the next day.
• Headache.
• Nausea.
• Diarrhea.

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.

All forms:

• If you still have trouble sleeping after 7-10 days, contact your doctor.
• Take this drug at bedtime.
• Take this drug only once in one night.
• Take this medicine on an empty stomach.
• Do not take during or immediately after a meal.

Tablets:

• 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.

Extended release tablets:

• Take this drug immediately before going to bed.
• Swallow whole. Do not chew, break or crush.
• 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.

Spray:

• Take this drug immediately before going to bed.
• Squirt into mouth over tongue.
• Prepare the nebulizer before first use.
• Test the pump empty by making 5 sprays.
• If you have not used the aerosol for more than 14 days, test the pump empty by 1 spray or until you see fine mist droplets.
• 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.

Sublingual lozenges (sublingual tablets):

• Do not touch the preparation with wet hands.
• Place under tongue and let dissolve completely. Do not chew, dissolve, or swallow the tablet.
• Do not eat, drink or smoke until the tablet has dissolved.

Edluar:

• 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.

Intermezzo

^® :

• Take only as needed if you wake up in the middle of the night and cannot get back to sleep. Take a dose only if you are at least 4 hours away from getting up. Do not take more than 1 dose per night.
• Keep only 1 packet of this drug near your bed. Keep all other packages elsewhere. Do not remove the drug from the package until you are ready to take a dose. After taking the drug, leave the empty bag in a conspicuous place. This will serve as a reminder that you have already taken your dose.

What if I miss a dose of a drug?

All preparations except Intermezzo:

• If you take 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.
• Do not take more than 1 dose of this drug in one day.
• In most cases, this drug is used as needed. Do not take the drug more often than prescribed by your doctor.

Intermezzo

^® :

• If you take the drug regularly, take the missed dose as soon as you can.
• If you are unable to sleep for at least 4 hours after taking the missed dose, do not take the missed dose and go back to your regular dosing schedule.
• Do not take 2 doses or an additional dose at the same time.
• Do not take more than 1 dose of this drug in one day.
• 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?

All forms:

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Monday, December 12, 2022

The dangers of using sleeping pills for sleep disorders.

Poluektov M.G.

Oksana Mikhailovna Drapkina , professor, doctor of medical sciences:

We continue. We are transported to an area that is not very known to us, it seems to me, but very interesting: neurology. Poluektov Mikhail Gurevich will talk about the dangers of using sleeping pills for sleep disorders.

Mikhail Gurevich Poluektov , Associate Professor, Candidate of Medical Sciences:

– Good afternoon, dear colleagues. Today we will talk about one of the biggest problems in Russian somnology – the problem of the abuse of sleeping pills. What does this entail?

At one time at an international conference, we presented data where we tried to analyze the frequency of seeking specialized help in sleep centers, in centers where they deal with sleep disorders, patients with different diagnoses. And it turned out that in the first place, more than half of the calls were associated with the so-called secondary insomnia – secondary insomnia. And more than half of the cases of secondary insomnia, secondary insomnia were associated with such a form of insomnia as dependence on sleeping pills.

I want to remind you again about insomnia. What is it in general? How to diagnose it? Insomnia, or insomnia, is not a disease, it is a clinical syndrome. He has three main points for diagnosis. Firstly, these are any sleep disorders. That is, if a person falls asleep badly, if he often wakes up, if he wakes up early in the morning and cannot fall asleep later – all this is insomnia. Any complaints about sleep disturbances are actually insomnia. These disorders occur when a person has enough time for sleep. This is the second starting point for the diagnosis of this syndrome. And the third point is that the consequences of such a sleep disturbance are a violation of daytime functioning. These can be a variety of disorders: it can be drowsiness, irritability, a feeling of fatigue, and difficulty concentrating, even gastroenterological complaints can be. That is, the range of daytime consequences of insomnia is quite wide. It is very important that insomnia is not just one disease. There are 9types of insomnia, in some of which sleeping pills are categorically contraindicated to prescribe.

Not so long ago we published a study that was conducted in Chuvashia at the Department of Andrey Vasilievich Golenkov, at the Department of Psychiatry, where the frequency of sleep disorders in a sample of the population of the Russian Federation was analyzed. And it turned out that about 20% of respondents in the general population are unhappy with their sleep. They answered yes to the question whether they had sleep disturbances often or constantly. But what we were most concerned about in the results of this study was that 4.5% of all respondents – not those who were unhappy with their sleep, but in general all those surveyed – constantly or almost constantly took sleeping pills. If, for example, we compare this with data from foreign studies, then only 0. 2% of the population in the general population takes sleeping pills, for example, in Western Europe or the United States of America. That is, the frequency of use of sleeping pills in the Russian Federation is several tens of times higher.

And most often the use of sleeping pills is associated with the so-called secondary insomnia, secondary insomnia. There are primary forms of insomnia, which I will talk about a little later, and there are secondary forms. Usually no one really tries to look for the cause of insomnia. If there is any diagnosis of the underlying disease, the diagnosis of insomnia is also attributed to it. There, “Discirculatory encephalopathy. Insomnia”, “Gastroesophageal reflux disease. Insomnia.” In fact, everything is not so simple, of course. We can talk about the presence of a causal relationship with the underlying disease if the sleep disturbance begins after the onset of the underlying disease or simultaneously with it, and if periods of change in the clinical picture of the underlying disease are also accompanied by a change in the severity of sleep disturbance. Then we have no doubt that this insomnia is secondary. For example, with pain syndromes, when the back hurts or the joint hurts, then, of course, there is no time for sleep until the appropriate drugs are taken. When the exacerbation subsides, sleep is restored. This is a very characteristic example of a typical secondary insomnia.

Insomnia in psychiatric disorders is also a very common form of secondary insomnia, accompanying almost any mental disorder: anxiety disorders, depressive disorders, panic disorders, and sleep disorders are very common in schizophrenia. That is, it is a very characteristic symptom of mental illness.

Another form of secondary insomnia is insomnia in diseases of the internal organs and the nervous system. I have touched on this subject a little. In patients with cerebral stroke, for example, sleep disorders are very common – 57% of the hospital population of such patients have sleep disorders.

In general, the probability of detecting insomnia in various forms of pathology not associated with a mental disorder is very high. That is, insomnia occurs in a variety of diseases: with heart disease, with arterial hypertension, with arrhythmias, with various respiratory problems. But most often, insomnia disorders, sleep disorders are found in diseases of the nervous system. In this table, we see that 6 times more often in patients with diseases of a neurological nature, sleep disorders occur than in a comparable control group without such diseases. This is much more common than, for example, in people with diabetes, with problems in the urogenital area, and so on. That is, neurological diseases lead after mental disorders in terms of the frequency of occurrence of insomnia (insomnia).

And a very big problem of secondary insomnia is insomnia associated with taking drugs or other substances. With this I began the story that more than half of the patients who turn to specialized centers for help have just this diagnosis – insomnia associated with drug dependence, or insomnia associated with taking medications. Most often, this is insomnia associated with the use of benzodiazepine hypnotics. You know that it is in the Russian Federation that certain benzodiazepine sleeping pills are extremely widespread and are used completely uncontrollably. Maybe barbituric addiction – very popular drugs contain phenobarbital. If you roughly count, then, for example, 100 drops of Valocordin is about one tablet of Phenobarbital. Phenobarbital is a first-generation sleeping pill that has a lot of unwanted side effects. Alcohol: also alcohol intake, alcohol abuse is accompanied by the development of a specific form of insomnia associated specifically with alcohol dependence. But with “recreational substances” – I mean energy tonics, some substances associated with nighttime pastime – we still don’t come across so often in our practice, and this is not such a pronounced problem, at least in those centers in which we are working.

We said that there are forms of secondary insomnia that are associated with certain diseases, and there are forms of primary insomnia. And the most common medical error is the use of sleeping pills in some forms of primary insomnia. There is only one form of primary insomnia for which sleeping pills must be taken. Indeed, it has been proven that if sleeping pills are prescribed in time for, for example, such a form of insomnia, which is called “adaptive insomnia”, or “acute insomnia”, or “stress reaction”, then the person quickly gets out of this stressful state, recovers faster. This is the most common, in fact, household insomnia. During the year, 1/5 of the population experiences this form of insomnia, because stress happens all the time. But most often this insomnia resolves spontaneously without the need to resort to any sleeping pills. But if it drags on, if it lasts for more than three months after the stress factor has ended, then most likely we will be talking about another form of sleep disorder, which I will talk about a little later. This is the only form of primary insomnia that is not associated with any disease, in which the appointment of a sleeping pill is indicated and helps to quickly get out of this stressful state.

What drugs are used most often? The most commonly used ligands are the GABA-A receptor complex. This is how it looks beautiful in an electronic photo. It is also called the Costa complex. This is an ion channel that is surrounded by five protein subunits, a molecule of gamma-aminobutyric acid is attached to certain places, and benzodiazepines are attached to certain places. Benzodiazepines increase the affinity of this receptor for GABA – GABA begins to act more strongly, causes a stronger inhibitory effect. And the hypnotic effect of the drug, whether sedative, or anxiolytic, or muscle relaxant, depends on which variety of one of the five subunits the hypnotic drug is attached to.

Benzodiazepines, non-selective. If we use hypnotics as benzodiazepines, they attach to the alpha-1 subunits of this complex, and to alpha-2, to alpha-3, 5, and accordingly they produce a whole range of effects, and desirable ones, such as sedative and hypnotic effects, and undesirable, if we use as sleeping pills – amnestic action, muscle relaxant. The anxiolytic effect is rather desirable.

More modern sleeping pills have a different structure – not benzodiazepine. These are Zaleplon, Zopiclone, Zolpidem – the so-called Z-drugs. They have a high affinity specifically for the alpha-1 subunit and almost do not bind to other subunits. They are considered to have less potential for unwanted side effects than the benzodiazepine hypnotics that preceded them.

What are the most common problems associated with the use of benzodiazepine sleeping pills? This is tolerance (addiction), that is, it is gradually required to apply an increasing and large dose of the drug in order to get the same effect. Dependence, withdrawal syndrome – the development of an abstinence syndrome is just included in the criterion of dependence: when we cancel the drug, sleep disturbances sharply increase, there is a whole range of side effects, primarily of a vegetative plan, and psychomotor agitation occurs. These are very undesirable effects that are really very poorly tolerated by patients.

Worsening of sleep apnea – more on that later. Reduced memory, attention, reaction time – the so-called cognitive toxicity. It is due to the fact that many benzodiazepine drugs that are used as sleeping pills have a very long half-life and continue to work both in the morning and in the afternoon, because they have not yet been excreted in sufficient quantities from the body. For actively working people, this can really become a problem, or, for example, when driving a car.

So-called behavioral toxicity is a problem for the elderly, of course, above all. Again, in the morning, when an older person gets up and the effect of the sleeping pill has not yet ended, this can lead to unwanted falls, which for older people can be fraught with complications.

Daytime sleepiness – also due to the long half-life of the beneficial effect of the sleeping pill becomes harmful.

Another approach to the use of these hypnotic drugs is not to increase the GABAergic transmission, when we increase the inhibitory effect on the brain, put it to sleep, but to inhibit the activating brain systems. It is one of the most important activating brain systems containing histamine and has an awakening property that stimulates wakefulness. If the receptors in this system are blocked, then the balance between the activating and inhibitory brain systems will be disturbed accordingly: a person will fall into sleep. This is the ideology behind the use of central blockers of histamine receptors.

Doxylamine is used for this, for example. This is an h2-subtype blocker, as I said, histamine receptors. It has a sedative, hypnotic effect. The half-life of the drug is 10 hours. Not as small, but significantly smaller than many commonly prescribed benzodiazepine sleeping pills. It is usually prescribed for a short period in acute forms of insomnia. It is issued according to the usual prescriptions. It can be used in pregnant women throughout the entire period of pregnancy – this is written in the new instructions for the drug.

There are certain restrictions on the use of this drug. It is not used in children, with caution if sleep apnea is suspected. Again, it is necessary to talk about apnea further. With caution – patients over 65 years of age due to possible dizziness and delayed reactions with the danger of falling. And due to the fact that it has an anticholinergic effect, it is contraindicated in patients with angle-closure glaucoma and prostate adenoma. That is, this sleeping pill has limitations for use.

What to do with a patient who 10 years ago came to the doctor, asked him for a sleeping pill, was prescribed (most likely it was a benzodiazepine sleeping pill), and now he comes 10 years later and says: “Doctor, I already two or three tablets of this drug do not help. Give me something else”? This is a really big problem, we need to work a lot with this patient, and here we propose an algorithm for working with such patients. First, you need to reduce the dose of the drug. Do not immediately remove the drug, but gradually reduce it in order to avoid a sharp onset of withdrawal syndrome, withdrawal syndrome. Unfortunately, in the Russian Federation there are no sedative-hypnotic drugs that would be dosed in drops, when it would be possible, for example, to gradually reduce the same Diazepam by one drop per night. But we recommend that patients somehow divide these tablets into several parts.

Then, if we manage to minimize the dose of the drug, go from, for example, three tablets to two, to one tablet, we transfer the patient to a non-hypnotic drug that has a sedative and hypnotic side effect. Most often, these are antidepressants with sedative effects: Mianserin, Trazodone.

In the future, if we manage to get away from a typical sleeping pill, and antidepressants do not become addictive, then in the future it is possible to get away from antidepressants: reduce the dose of the drug, switch to lighter over-the-counter drugs.

If that doesn’t help, if the patient can’t bear the period of dose reduction, the period of withdrawal, we probably have only one remedy left – the so-called drug holidays. Some patients can live according to this scheme for years: 1 plus 1, 3 plus 1 – live and sleep relatively tolerably. What is the essence of this scheme? Three weeks, for example, the patient takes a sleeping pill, three weeks he does not take a sleeping pill, but takes anything: sedative herbs, but most often these are over-the-counter drugs. This is necessary in order to restore sensitivity to the original drug. And the patient himself already knows that he will indeed sleep very badly for three weeks, he will suffer, but he will still sleep, because sleep is a basic need of the body. But for the next three weeks he will sleep wonderfully, and he will not develop addiction during these three weeks. At the same time, it is important to support him: we prescribe behavioral therapy, limit the time spent in bed, limit daytime sleep, for example, teach him to follow the rules of sleep hygiene, and there are so-called “supporting” visits, when the doctor and the patient simply talk “Is everything observed? “.

I said that another problem with the use of many sleeping pills is the danger of aggravating a condition such as obstructive sleep apnea, or Pickwickian syndrome. There’s a classic image of this fat guy Joe, who served a certain gentleman and got into strange situations all the time, falling asleep while eating, falling asleep ringing the bell, falling asleep all the time. Therefore, since this was the first novel by Charles Dickens, The Pickwick Papers, this syndrome was called Pickwick Syndrome for a long time.

And then it turned out that this condition is due to the fact that during sleep, such people, most often with morbid obesity, have a huge number of breath holdings, and because of this they can hardly fall into deep sleep. For years they do not get deep sleep, and consequently have constant daytime sleepiness. Most often it is associated with morbid obesity. Here we see how different the lumen of the upper respiratory tract is in such patients, and when they fall asleep, this lumen becomes even smaller.

One of the main pathogenetic mechanisms for the development of complications in this condition are fluctuations in blood pressure associated with changes in the level of oxygen saturation in the blood and with sympathetic hyperactivation.

At the same time, if sleeping pills are taken, then a very unpleasant phenomenon is observed when there is a discoordination of muscle contractions of those muscles that support the lumen of the upper respiratory tract, which do not allow them to close during inhalation, and the diaphragm.

In the upper graph, we see that during the respiratory cycle there is a synchronous activation of these muscles, and when, for example, alcohol is used, the activation of the hypoglossal muscle, which is responsible for ensuring the lumen of the airways, is significantly reduced. And there is such a situation that the muscles of the upper respiratory tract do not have time to prepare for the negative pressure of the air that enters the respiratory tract during inspiration, and obstruction may occur. Most often, it occurs in people with an existing diagnosis of sleep apnea. Therefore, the vast majority of sleeping pills are contraindicated in patients with sleep apnea. Benzodiazepine drugs have contraindications in their instructions. Even the most modern Z-drugs have limitations for use, including Doxylamine: the instructions also say that they should be used with caution in such violations.

What should be done about sleep apnea? For sleep apnea, the treatment of choice is the use of a device called a CPAP machine. Through the mask, which is applied to the patient’s face before going to bed, air is supplied, which constantly keeps the airways open and does not allow them to subside. It is the method of choice in the treatment of moderate to severe sleep apnea.

So, when should sleeping pills be prescribed to avoid the development of these undesirable effects? Sleeping pills are prescribed for acute insomnia, for acute insomnia (under stress, for example, during an exacerbation of the underlying disease), but for chronic insomnia, non-drug methods of treatment have priority: normalization of sleep hygiene and behavioral methods.