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FDA orders recommended dose of Ambien and other insomnia drugs cut in half for women

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Manufacturers of Ambien, as well as certain other medications containing zolpidem, were ordered Thursday by the U.S. Food and Drug Administration to lower the recommended dose by half — for women.

The FDA asserts that "zolpidem doses for women and men should be different because women eliminate zolpidem from their bodies at a slower rate than men."

READ: Complete FDA Safety Announcement (document below)

Ambien, Ambien CR, Edluar, Zolpimist — and their generic forms — were named in the FDA's safety annoucement, "Risk of next-morning impairment after use of insomnia drugs." 

Patients should be informed, they say, that impairment of mental alertness from sleep drugs can be present the morning after use, despite feeling fully awake.

Doses will be lowered from 10 milligrams to 5 milligrams for regular products. For extended-release formulations, doses will be lowered from 12.5 milligrams to 6.25 milligrams.

The order follows new research that suggest next-morning drug levels in the bloodstream are present in high enough concentration to potentially interfere with driving.

The FDA recommends health care professionals also consider the lower doses for men since it "provides sufficient efficacy" for many. It is not required, however.

The Associated Press reports that Ambien has been blamed for several recent high-profile driving accidents in the past year, and that the FDA has received more than 700 reports of driving-related problems connected to zolpidem over the years.
 

"All sleep drugs have the potential to cause this, so health professionals should prescribe — and patients should take — the lowest dose that is capable of preventing insomnia," said Dr. Ellis Unger, a director in FDA's Office of Drug Evaluation, in a call with reporters, notes AP.

"We really don't want people to change the dose they're on," Unger continued. "We want them to talk to their health care provider." 

FDA Safety Announcement - Sleeping Pills [1-10-2013]

With contributions by AP

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