Sleep Drugs Under Gun for Doing Job Too Well

FDA is cracking down on drowsy drugs that affect drivers
By Ruth Brown,  Newser Staff
Posted Aug 14, 2013 2:35 PM CDT
Sleep Drugs Under Gun for Doing Job Too Well

(Newser) Back in January, the FDA told drugmakers to reduce their recommended dosage for sleep aids in an effort to stop people from zonking out on their morning drive to work. Now it's cracking the whip. The agency says it will push manufacturers for more extensive driving tests, write specific guidelines for those tests, and widen its focus to any drug that causes drowsiness, such as allergy meds, the New York Times reports. Part of the problem, says an FDA doctor, is that people tend to ignore the driving warnings on drug labels, and many actually don't realize their driving ability is impaired.

Drugmakers already do some driving tests, but they vary wildly, and until recently, the FDA just looked at whether the average person was too drowsy. Now, reports the Times, it's recognizing that a drug's effect can vary from person to person—one new sleep drug, Intermezzo, has different dosages for men and women because tests showed woman stayed drowsier longer; another, suvorexant, was initially rejected altogether because it affected women so much. (Read more FDA stories.)

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