FDA Wants Lower Sleep Drug Doses, May Require Driving Simulations

January 25, 2013
The FDA is asking manufacturers of insomnia drugs Ambien, Ambien CR, Edluar and Zolpimist to halve the current recommended dosages for women and consider halving the recommended dosages for men. The new recommended dosage of sleep drugs that contain the active ingredient zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for extended-release products, such as Ambien CR. For men, manufacturers should tell health professionals to consider prescribing the same dosages as for women.
Washington Drug Letter