FDA issues Ambien warning that drug’s effects may last longer than intended

by Michael Heygood

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

FDA is now warning health care professionals to caution all patients (men and women) who use zolpidem that the effects of the drug may linger into the next morning. FDA is recommending that the bedtime dose be lowered because new data shows that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.

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.

As a result of “the risks of next-morning impairment for activities that require complete mental alertness, including driving,” the FDA has issued the following recommendations:

  • 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, helath care professionals should prescribe the lowest dose that treats the patient’s symptoms.
  • Health Care professionals should 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.

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.

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.

Zolpidem is available as an oral tablet (Ambien and generics), an extended-release tablet (Ambien CR and generics), a sublingual (under-the-tongue) tablet (Edluar), and an oral spray (Zolpimist).

Zolpidem is also available under the brand name Intermezzo, a lower dose sublingual tablet that is approved for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Over the years, FDA has received reports of possible driving impairment and motor vehicle accidents associated with zolpidem; however, in most cases it was difficult to determine if the driving impairment was related to zolpidem or to specific zolpidem blood levels because information about time of dosing and time of the impairment was often not reported.

Recently, data from clinical trials and driving simulation studies have become available that allowed FDA to better characterize the risk of driving impairment caused by specific blood levels of zolpidem and to recognize the increased risk of driving-impairing blood levels of zolpidem in women. This led FDA to require the manufacturers of certain zolpidem-containing products to revise the dosing recommendations.

FDA has received about 700 reports of zolpidem and “impaired driving ability and/or road traffic accident.” Following a zolpidem label change in 2007, which added information to the Warnings and Precautions section of the label about complex sleep-related behaviors, including sleep-driving (patients getting out of bed while not fully awake and driving), there was a great deal of media attention. Since such publicity tends to “stimulate” reporting, this led to the considerable number of reports of zolpidem and impaired driving that were submitted to FDA’s Adverse Event Reporting System (AERS) database.

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by Michael Heygood

Michael Heygood is a licensed attorney and partner at HO&P who focuses on insurance and corporate litigation, and other civil arenas. Michael has been named multiple times to the Super Lawyers List.