The FDA has ordered manufacturers of popular sleeping aids (Ambien, Zolpimist, Edluar) to cut the recommended dosages for women in half, after studies demonstrating that residual effects of the drug are often present at waking and beyond (January 10).
Women process the drugs more slowly, meaning that they may be executing tasks, such as operating a motor vehicle, under the influence, while unaware of the risks.
“Most people thought that by the morning it is gone,” Dr. Robert Temple, deputy director for clinical science in the F.D.A.’s Center for Drug Evaluation and Research 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.”
The FDA is also recommending that manufacturers use the lower doses for men, though it will not be mandatory. The dosage reduction applies to sleep aids containing the drug Zolpidem.
by RTT Staff Writer
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