Monday, 8 October 2012

zolpidem


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.


What is the most important information I should know about zolpidem?


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. Some people using this medicine have engaged in activity such as driving, eating, or making phone calls 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. Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not take this medicine if you have consumed alcohol during the day or just before bed. Zolpidem may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

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.


What should I discuss with my healthcare provider before taking zolpidem?


Some people using this medicine have engaged in activity such as driving, eating, or making phone calls 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. Zolpidem tablets may contain lactose. Use caution if you are sensitive to lactose.

To make sure you can safely take zolpidem, tell your doctor if you have any of these other conditions:


  • 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. Zolpidem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling 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?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


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. Breaking the pill may cause too much of the drug to be released at one time.

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.

See also: Zolpidem dosage (in more detail)

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 while taking zolpidem?


Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

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 a serious side effects:

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




  • trouble breathing or swallowing; or




  • feeling like you might pass out.



Less serious side effects may include:



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




  • tired feeling, loss of coordination;




  • dry mouth, nose or throat irritation;




  • nausea, constipation, diarrhea, upset stomach;




  • stuffy nose, sore throat; 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.


Zolpidem Dosing Information


Usual Adult Dose for Insomnia:

Immediate release: 10 mg orally once a day immediately before bedtime. Alternatively, the dose may be administered as one 10 mg 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: 12.5 mg orally once a day 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 five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.

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.


What other drugs will affect zolpidem?


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

Tell your doctor about all other medicines you use, especially:



  • chlorpromazine (Thorazine);




  • itraconazole (Sporanox), ketoconazole (Nizoral);




  • rifampin (Rifadin, Rimactane, Rifater); or




  • antidepressants such as imipramine (Tofranil), or sertraline (Zoloft).



This list is not complete and other drugs may interact with zolpidem. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More zolpidem resources


  • Zolpidem Side Effects (in more detail)
  • Zolpidem Dosage
  • Zolpidem Use in Pregnancy & Breastfeeding
  • Drug Images
  • Zolpidem Drug Interactions
  • Zolpidem Support Group
  • 304 Reviews for Zolpidem - Add your own review/rating


  • zolpidem Oral, Oromucosal Advanced Consumer (Micromedex) - Includes Dosage Information

  • Zolpidem Prescribing Information (FDA)

  • Zolpidem MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ambien Consumer Overview

  • Ambien Monograph (AHFS DI)

  • Ambien Prescribing Information (FDA)

  • Ambien CR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ambien CR Prescribing Information (FDA)

  • Edluar Consumer Overview

  • Edluar MedFacts Consumer Leaflet (Wolters Kluwer)

  • Edluar Prescribing Information (FDA)

  • Intermezzo Consumer Overview

  • ZolpiMist Consumer Overview

  • Zolpimist Prescribing Information (FDA)

  • Zolpimist Oral Spray MedFacts Consumer Leaflet (Wolters Kluwer)



Compare zolpidem with other medications


  • Insomnia


Where can I get more information?


  • Your pharmacist can provide more information about zolpidem.

See also: zolpidem side effects (in more detail)


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