FDA: Lower Ambien's Dose to Prevent Drowsy Driving

Blood levels from nighttime dose of sleep aid can remain too high the next morning, agency says

From the WebMD Archives

By Amanda Gardner

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard while performing certain tasks such as driving.

The move follows the FDA's request to manufacturers in January that drugs containing zolpidem carry instructions that lower the recommended dose and provide more safety information to patients.

"FDA has approved these changes because of the known risk of next-morning impairment with these drugs," the agency said in a statement released Tuesday on its website.

Sleep medications containing zolpidem include Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien and Ambien CR.

"The purpose of the lowering is to help decrease the risk of next-morning impairment of activities that require alertness," Dr. Ellis Unger, director of the Office of Drug Evaluation I at the FDA's Center for Drug Evaluation and Research, said at the time of the agency's request to manufacturers. "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 said.

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 that "women appear to be more susceptible to risk for next-morning impairment because they eliminate zolpidem from their bodies more slowly."

It's not clear why women eliminate the substance from their bodies more slowly than men.

Pagination