FDA to Ambien, Other Sleep Aids: Lower Recommended Dosage

Tim Boyle/Getty Images(WASHINGTON) — The U.S. Food and Drug Administration is telling makers of certain sleeping pills, such as Ambien, to lower the recommended dose on the label because it’s worried that lingering drowsiness could impair driving and other activities that require people to be alert.

The recommended dose will be halved for women, and labels must recommend considering a lower dose for men.

“Today’s action involves products that contain zolpidem, sold as Ambien, Ambien CR and their generics, Edluar and Zolpimist,” said the FDA’s Dr. Ellis Unger.

The FDA found that the effects of prescription sleeping pills linger for an extended period of time — even into the next morning.

Data show that women clear zolpidem, the active ingredient, more slowly than men. Unger says the new requirements take that into consideration.

“For women, for products that contain the immediate release form of zolpidem, FDA has asked the manufacturers to cut the recommended dosage in half…from ten milligrams to five milligrams,” Unger said. He added that alertness can be impaired even in people who don’t feel drowsy.

Companies have 30 days to come back to FDA with labeling changes or arguments about why they shouldn’t change the label.

The FDA is examining other sleep aids and will require manufactures to do some driving studies. These types of studies will also be a requirement going forward for any new sleep medication on the market.

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