The Food and Drug Administration (FDA) announced January 10 that it is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended dosages. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.
Using lower dosages of zolpidem means less of the drug will remain in the blood in the morning. Since women eliminate zolpidem from their bodies more slowly than men do, the FDA informed manufacturers that the recommended dosage 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 men, the FDA informed manufacturers that the labeling should recommend that health care professionals consider prescribing the same lowered dosages. Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urged 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.