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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."
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.