Friday, January 11, 2013

Ambien dose halved by FDA

Published: Jan. 10, 2013 at 8:57 PM
WASHINGTON, Jan. 10 (UPI) -- The U.S. Food and Drug Administration said the dose of Ambien, a widely prescribed sleeping pill, might be high enough the day after use to impair driving.

The FDA recommended the bedtime dose of zolpidem should be lowered because data showed blood levels in some patients might be high enough the morning after use to impair activities that require alertness such as driving.

Thursday's announcement focused on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar and Zolpimist.

The FDA is requiring the manufacturers of these drugs to lower the recommended dose. The FDA recommended the dose of zolpidem for women should be lowered from 10 milligrams to 5 mg for immediate-release products such as Ambien, Edluar and Zolpimist, and from 12.5 mg to 6.25 mg for extended-release products -- Ambien CR.

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