The Food and Drug Administration announced on Thursday that it was requiring manufacturers of popular sleeping pills like Ambien and Zolpimist to cut their recommended dosage in half for women, after laboratory studies showed that they can leave people still sleepy in the morning and at risk for accidents.
The agency issued the requirement for drugs containing the active ingredient zolpidem, by far the most widely used sleep aid. Using lower doses means less of the drug will remain in the blood in the morning hours, and leave people who take it less exposed to the risk of impairment while driving to work.
Women eliminate zolpidem from their bodies more slowly than men and the agency told manufacturers that the recommended dosage for women should be lowered to 5 milligrams from 10 milligrams for immediate-release products like Ambien, Edluar and Zolpimist. Dosages for extended-release products should be lowered to 6.25 milligrams from 12.5, the agency said. The agency also recommended lowering dosages for men.
An estimated 10 to 15 percent of women will have a level of zolpidem in their blood that impairs driving eight hours after taking the pill, while only about 3 percent of men do, said Dr. Robert Temple, deputy director for clinical science in the F.D.A.'s Center for Drug Evaluation and Research.
Doctors will still be told that they can prescribe the higher dosage if the lower one does not work, Dr. Temple said.
“Most people thought that by the morning it is gone,” he said. “What we’re reminding people is that is sort of true, but that in some women who take a full 10 milligram dose, and in a lot of people who take the control release dose, it is not entirely true. Some people will be impaired in the morning.”
F.D.A. Requires Cuts to Dosages of Ambien and Other Sleep Drugs
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F.D.A. Requires Cuts to Dosages of Ambien and Other Sleep Drugs
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F.D.A. Requires Cuts to Dosages of Ambien and Other Sleep Drugs
