Zolpidem

Pronunciation

Generic Name: zolpidem (zole PI dem)
Brand Names: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist

What is zolpidem?

Zolpidem is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Zolpidem is used to treat insomnia. The immediate-release forms of zolpidem are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. The extended-release form of zolpidem is Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.

Your doctor will determine which form of zolpidem is best for you.

Zolpidem may also be used for purposes not listed in this medication guide.

Important information

In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for zolpidem. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Slideshow: Need To Catch Some Shut-Eye? Tips on Getting the Sleep You Need

Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Zolpidem may be habit forming. Keep the medication in a place where others cannot get to it.

Zolpidem may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Before taking this medicine

Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.

You should not use this medication if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.

To make sure zolpidem is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);

  • sleep apnea (breathing stops during sleep);

  • myasthenia gravis;

  • a history of depression, mental illness, or suicidal thoughts; or

  • a history of drug or alcohol addiction.

Zolpidem may be habit forming and should be used only by the person it was prescribed for. Never share zolpidem with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

Zolpidem can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The sedative effects of zolpidem may be stronger in older adults.

Do not give this medicine to anyone younger than 18 years of age.

It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

How should I take zolpidem?

In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for zolpidem. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before.

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Zolpidem comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.

Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.

Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice.

Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.

Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole.

Do not swallow the Edluar or Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water.

Spray Zolpimist directly into your mouth over your tongue. Prime the spray before the first use by pumping 5 test sprays into the air, away from your face. Prime the spray with 1 test spray if it has not been used for longer than 14 days.

Store at room temperature away from moisture and heat. Do not freeze. Keep the Zolpimist bottle upright when not in use.

What happens if I miss a dose?

Since zolpidem is taken only at bedtime, you will not be on a frequent dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What should I avoid?

Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Zolpidem side effects

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using zolpidem and call your doctor at once if you have:

  • chest pain, fast or irregular heartbeat, feeling short of breath;

  • trouble breathing or swallowing; or

  • feeling like you might pass out.

Common zolpidem side effects may include:

  • daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;

  • tired feeling, loss of coordination;

  • stuffy nose, dry mouth, nose or throat irritation;

  • nausea, constipation, diarrhea, upset stomach; or

  • headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Zolpidem dosing information

Usual Adult Dose for Insomnia:

Immediate release:
Men: 10 mg orally once daily immediately before bedtime
Women: 5 mg orally once daily immediately before bedtime

Alternatively, the dose may be administered as a sublingual tablet placed under the tongue to disintegrate once a day immediately before bedtime. The sublingual tablet should not be swallowed or taken with water. The recommended duration of zolpidem therapy is generally 7 to 10 days. Each metered actuation (one spray) of zolpidem tartrate oral spray delivers 5 mg of zolpidem.

Controlled release:
Men: 12.5 mg orally once daily immediately before bedtime
Women: 6.25 mg orally once daily immediately before bedtime

Sublingual: The recommended and maximum dose is 1.75 mg SL for women and 3.5 mg SL for men only once per night (to be taken only if the patient has at least 4 hours of bedtime remaining before the planned time of waking).

If zolpidem is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.

The safety of immediate release zolpidem has only been established for treatment regimens of up to 5 weeks. Administration of immediate release zolpidem for therapies longer than 5 weeks is not recommended.

Comments: FDA is recommending that the bedtime dose of zolpidem be lowered because blood levels in some patients may be high enough the morning to impair activities that require alertness, including driving. Women are more susceptible to this risk because they eliminate zolpidem more slowly than men. This includes products which are marketed as generics and under the brand names Ambien (R), Ambien CR (R), Edluar (R), and Zolpimist (R). Patients who take insomnia drugs can experience impairment of mental alertness even if they feel fully awake. The risk for next morning impairment is highest for patients taking the extended-release forms. FDA is requiring manufacturers to lower the dose for women from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for extended-release products. FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next morning impairment for activities that require mental alertness. The recommended doses of Intermezzo (R), a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

Usual Geriatric Dose for Insomnia:

Immediate release: 5 mg once a day immediately before bedtime. Alternatively, the dose may be administered as one 5 mg sublingual tablet placed under the tongue to disintegrate. The sublingual tablet should not be swallowed or taken with water. The recommended duration of zolpidem therapy is generally 7 to 10 days. The dosage can be titrated up to 10 mg nightly if necessary depending on patient response.

Controlled release: 6.25 mg orally once a day immediately before bedtime.

Sublingual: The recommended and maximum dose is 1.75 mg only once per night (to be taken only if the patient has at least 4 hours of bedtime remaining before the planned time of waking).

If zolpidem is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.

The safety of immediate release zolpidem has only been established for treatment regimens of up to five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.

Comments: FDA is recommending that the bedtime dose of zolpidem be lowered because blood levels in some patients may be high enough the morning to impair activities that require alertness, including driving. Women are more susceptible to this risk because they eliminate zolpidem more slowly than men. This includes products which are marketed as generics and under the brand names Ambien (R), Ambien CR (R), Edluar (R), and Zolpimist (R). Patients who take insomnia drugs can experience impairment of mental alertness even if they feel fully awake. The risk for next morning impairment is highest for patients taking the extended-release forms. FDA is requiring manufacturers to lower the dose for women from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for extended-release products. FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next morning impairment for activities that require mental alertness. The recommended doses of Intermezzo (R), a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

What other drugs will affect zolpidem?

You may need a lower dose of zolpidem if you take other medicines that make you sleepy or slow your breathing (such as cold medicine, pain medication, muscle relaxants, and medicine for depression, anxiety, or seizures). Tell your doctor if you are currently taking any of these medications.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with zolpidem, especially:

  • chlorpromazine;

  • itraconazole or ketoconazole;

  • rifampin; or

  • an antidepressant--imipramine, sertraline.

This list is not complete. Other drugs may interact with zolpidem, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about zolpidem.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use zolpidem only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 8.02. Revision Date: 2013-05-15, 3:09:39 PM.

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