Washington, DC: The Food and Drug Administration (FDA) has issued a notification to the public concerning new information about zolpidem products, which are approved for bedtime use, and are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist, and Intermezzo.
The 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.
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 also requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose.
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.