Skip to Content

Ambien CR FDA Alerts

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

FDA Adds Boxed Warning for Risk of Serious Injuries Caused by Sleepwalking with Certain Prescription Insomnia Medicines

Apr 30, 2019

Audience: Audience: Consumer, Health Professional, Pharmacy

The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.

As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.

Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose. These behaviors can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.

Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.

Health care professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death. Tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behavior.

Patients should stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine.

We identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death (see Data Summary). This number includes only reports submitted to FDA* or those found in the medical literature,1-5 so there may be additional cases about which we are unaware. These cases included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts. Patients usually did not remember these events. The underlying mechanisms by which these insomnia medicines cause complex sleep behaviors are not completely understood.

FDA is also reminding the public that all medicines 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 medicines, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia medicines can experience decreased mental alertness the morning after use even if they feel fully awake.

We communicated safety information associated with certain insomnia medicines in January 2013 (risk of next-morning impairment with zolpidem), May 2013 (approved lower recommended doses for zolpidem), and May 2014 (risk of next-morning impairment with eszopiclone; lowered recommended dose). We are continuing to monitor the safety of insomnia medicines and will update the public as new information becomes available.

To help FDA better track safety issues with medicines, we urge health care professionals and patients to report side effects involving eszopiclone, zaleplon, and zolpidem or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

*The cases were reported to the FDA Adverse Event Reporting System (FAERS).

Source: FDA

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:

[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:

 

[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 Ambien CR Resources