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FDA: Lower Ambien's Dose to Prevent Drowsy Driving
Date:1/11/2013

By Amanda Gardner
HealthDay Reporter

THURSDAY, Jan. 10 (HealthDay News) -- The U.S. Food and Drug Administration announced Thursday that it is asking manufacturers of sleep medications containing zolpidem -- including Ambien -- to lower the recommended doses and to provide more safety information to patients.

These sleep medications include Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien and Ambien CR.

Officials are concerned that blood levels of zolpidem are high enough the morning after taking the drugs to continue to impair one's ability to perform certain activities.

"The purpose of the lowering is to help decrease the risk of next-morning impairment of activities that require alertness," said Dr. Ellis Unger, director of the Office of Drug Evaluation I at the FDA's Center for Drug Evaluation and Research. "We're particularly concerned about driving. A large fraction of the population drives and driving is an inherently dangerous activity."

Lowering the nighttime dose means there will be less residual drug in the blood by the time the person wakes up. Extended-release forms of the drugs tend to stay in the body longer.

The FDA has told manufacturers that recommended doses for women should be cut in half, from 10 milligrams to 5 milligrams 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 agency has asked manufacturers to change the labeling to recommend that doctors and other health-care professionals consider prescribing lower doses, meaning 5 mg for immediate-release products and 6.25 mg for extended-release products.

In explaining the different recommendations for men and women, Unger said at a midday news conference that "women appear to be more susceptible to risk for next-morning impairment because they eliminate zolpidem from their bodies more slowl
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