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FDA changes recommended sleeping pill dosage for women


For years the sleep drug Ambien has been associated with strange behaviors.

Patients have reported everything from painting their houses and binge eating to having sex and conversations with their spouses--with no recollection of the events the morning after taking the drug.

A possible explanation

As it turns out, there could be an explanation for the unusual--and sometimes dangerous--sleep walking-like behavior that often accompanies the medication.

Last week the Food and Drug Administration announced that, after further review, women should be taking about half as much of the drug than previously recommended. This will help prevent the hallmark drowsiness that's associated with sleeping drugs that contain zolpidem.

More risks for women

The reason the FDA focused the announcement on women is because women's bodies take longer to metabolize Ambien than men. The research found that about 10 to 15 percent of women taking the drug could be too drowsy to drive--even eight hours after taking it.

“In this case, the F.D.A. may be behind the eight ball,” Daniel Carlat, an associate clinical professor of psychiatry at Tufts University, told the New York Times. “Few doctors will be surprised hearing about this. They’ll say, ‘Oh yeah, we’ve already seen this in our patients."

The new dosage recommendations came as the result of clinical trials on a separate drug, Intermezzo, which was found to pose drowsiness risks above a certain dose.

The FDA says that the recommended Ambien, Edluar and Zolpimist dose for women should be 5 milligrams (not 10). The agency also recommends that health care providers consider lowering doses for men.

“A lot of people are wondering about the elephant in the room,” said Dr. Ellis Unger, an official at the FDA's Center for Drug Evaluation and Research. “Why did this take so long? This is science, and our thinking evolves over time.”

Source: New York Times