In response to new data indicating that zolpidem drug levels in some patients may be high enough the morning after use to impair activities that require alertness, the FDA announced that it is requiring manufacturers of sleep drugs containing zolpidem to lower current recommended doses. The FDA action affects the makers of Ambien and Ambien CR (both brand name and generic), Edluar, and Zolpimist.
Because women eliminate zolpidem from their bodies more slowly than do men, the FDA notified manufacturers that the recommended dose should be lowered for women and that labeling should recommend that health care professionals consider a lower dose for men as well. Data show that the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA is urging all health care professionals to caution all patients who use these products about the risk of next-morning impairment for activities that require mental alertness, including driving.