Cedars-Sinai Medical Center

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A BI-WEEKLY PUBLICATION FROM THE CEDARS-SINAI CHIEF OF STAFF Jan. 18, 2013 | Archived Issues

FDA lowers recommended dose of zolpidem products

Pharmacy focus

The U.S. Food and Drug Administration 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.

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FDA lowers recommended dose of zolpidem products

Pharmacy focus

The U.S. Food and Drug Administration 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.

Zolpidem products approved for bedtime use are marketed as generics and under the brand names Ambien, Ambien CR, Edluar and Zolpimist.

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.

The FDA urges health care professionals to caution all patients who use these products about the risks of next-morning impairment for activities that require complete mental alertness. The agency also says:

  • 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 even though the patient feels fully awake.

The recommended doses of Intermezzo, a lower-dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

Click here to read the MedWatch alert, including links to a drug safety communication.