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FDA Views Sleep Aids With More Critical Perspective

Filed August 14th, 2013 Laurie

The U.S. Food and Drug Administration (FDA) is studying the effects sleeping aids like Ambien have on the body, particularly how easy it is for patients to wake up the morning after taking one of the drugs.

Studies suggest that Ambien and other sleep aids continue to make drivers drowsy well into the next day. Law enforcement officials have struggled with how to deal with drivers who are under the influence of prescription drugs. According to a 2007 government study, nearly five percent of daytime drivers tested positive for prescription or over-the-counter drugs, the NYTimes.com reported.

Close to 60 million prescriptions were written for sleep aids in the U.S. last year.

The FDA rejected an application by Merck to approve a new sleep aid called suvorexant after tests showed some people had difficulty driving the next day. The FDA has also warned the public about taking over-the-counter drugs like Benadryl because the sedating effects can last into the next day. The agency also cut the recommended dosage of Ambien for women in half for the same reason, according to NYTimes.com.

Dr. Ronald Farkas, the clinical team leader for the FDA’s division of neurology products, told a group of industry experts in February that it would be too simple to tell people not to drive unless they feel OK. “I think this has penetrated now that this is not adequate. It is still good advice that, if you feel impaired, don’t drive. But if you feel fine, you might be impaired.”

The FDA has changed its thinking when it comes to what constitutes impaired driving. “Some people have higher blood levels than others, and some seem to be more sensitive than others,” Dr. Farkas explained to the New York Times in a phone interview.

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