FDA: Reduce bedtime dose of sleep meds

January 15, 2013

Silver Spring, MD – The Food and Drug Administration is requiring makers of certain sleep medications to lower the recommended bedtime dosage for women because the drug may linger in their systems and lead to impaired morning driving.

The agency’s Jan. 10 announcement applies to manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, all of which contain the ingredient zolpidem. FDA said studies show zolpidem levels in some patients were high enough the next morning to affect activities requiring alertness. Cutting the dose in half as recommended would mean less of the drug will be present in the morning. The risk is highest with the extended-release forms of the drugs, FDA said.

Although the recommendation is for women, whose bodies flush the drug more slowly than men, FDA said labels should advise health care professionals to also consider lower doses for men.