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Federal Regular Requires Dose Reduction for Women Taking Ambien, Other Sleep Aids

Filed January 11th, 2013 admin

The dosage of sleeping aid pills, such as Ambien, women take should be cut in half, the U.S. Food and Drug Administration (FDA) said after laboratory studies and driving tests confirmed the risks of drowsiness associated with the drugs.

The FDA’s recommendation applies to all drugs containing the active ingredient zolpidem, which is the most widely used sleep aid, The New York Times said. The use of lower doses will result in less of the drug remaining in the bloodstream during morning hours and will reduce the risk that people who use it will be impaired while driving, according to the agency.

The FDA’s recommendation was focused on women because they take longer to metabolize the drug than men. An estimated 10 percent to 15 percent of women will have a level of zolpidem in their blood that could impair driving eight hours after taking the pill, compared to about 3 percent of men, according to the Center for Drug Evaluation and Research, The New York Times said. FDA officials said they had received about 700 reports of driving accidents with people on zolpidem over the years.

The FDA’s recommendation comes after the agency reviewed driving simulation studies from trials of the drug, Intermezzo. The agency linked the driving simulation information with data from manufacturers on the amount of zolpidem in patients’ blood and found that levels above about 50 nanograms per milliliter increased the chance of having an accident while driving. The agency then informed manufacturers that the recommended dose for women should be lowered to 5 milligrams from 10 for products like Ambien, Edluar, and Zolpimist, said The New York Times.

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