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zolpidem FDA Alerts

The FDA Alert(s) below may be specifically about zolpidem or relate to a group or class of drugs which include zolpidem.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for zolpidem

Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

May 14, 2013

Audience: Family Practice, Health Professional, Patient

Including Ambien, Ambien CR, Edluar, and Zolpimist 

[UPDATE 05/14/2013] Today, the U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs.

[Posted 01/10/2013]

ISSUE: FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. This announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.

FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.

For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men.

Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose.

FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.

FDA prepared a list of questions and answers to provide an additional overview of this safety issue. See the FDA Drug Safety Communication for a Data Summary.

BACKGROUND: Zolpidem is a sedative-hypnotic (sleep) medicine used in adults for the treatment of insomnia. It is marketed as generics and under the brand-names Ambien, Ambien CR, Edluar, Zolpimist, and Intermezzo.

RECOMMENDATION: 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 complete mental alertness, including driving.

  • The recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).
  • For zolpidem and other insomnia drugs, prescribe the lowest dose that treats the patient’s symptoms.
  • Inform patients that impairment from sleep drugs can be present despite feeling fully awake.
  • The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[01/10/2013 - Drug Safety Communication - FDA]
[01/10/2013 - Questions and Answers - FDA]
[01/10/2013 - Consumer Update - FDA]
[01/10/2013 - News Release - FDA]

Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

Jan 10, 2013

Audience: Family Practice, Health Professional, Patient

Including Ambien, Ambien CR, Edluar, and Zolpimist 

 

[Posted 01/10/2013]

ISSUE: FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. This announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.

FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.

For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men.

Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose.

FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.

FDA prepared a list of questions and answers to provide an additional overview of this safety issue. See the FDA Drug Safety Communication for a Data Summary.

BACKGROUND: Zolpidem is a sedative-hypnotic (sleep) medicine used in adults for the treatment of insomnia. It is marketed as generics and under the brand-names Ambien, Ambien CR, Edluar, Zolpimist, and Intermezzo.

RECOMMENDATION: 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 complete mental alertness, including driving.

  • The recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).
  • For zolpidem and other insomnia drugs, prescribe the lowest dose that treats the patient’s symptoms.
  • Inform patients that impairment from sleep drugs can be present despite feeling fully awake.
  • The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[01/10/2013 - Drug Safety Communication - FDA]
[01/10/2013 - Questions and Answers - FDA]
[01/10/2013 - Consumer Update - FDA]
[01/10/2013 - News Release - FDA]

Ambien, Ambien CR (zolpidem tartate)

Mar 14, 2007

Audience: Healthcare professionals, consumers

[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken.

[March 14, 2007 - News Release - FDA]

More zolpidem Resources