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FDA Urges Lower Bedtime Doses of Insomnia Drug

FDA Urges Lower Bedtime Doses of Insomnia Drug [the Philadelphia Inquirer]

From Philadelphia Inquirer (PA) (January 11, 2013)

Jan. 11--Driving is dangerous enough without people falling asleep at the wheel, so on Thursday, the U.S. Food and Drug Administration urged patients and doctors to lower the bedtime doses of a common insomnia drug, which was prescribed about 40 million times in 2011.

The new safety warnings are for the sleep drug zolpidem, which is sold as a generic and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.

The new warnings came after clinical tests for a recently approved drug were coupled with tests involving driving simulators. The FDA will now require that driving-simulation tests be conducted as part of any new application for insomnia drugs.

IMS Health, a health-care technology and information company with an office in Plymouth Meeting, said that about 60 million prescriptions were written in 2011 for all sleeping pills, about two thirds of those some form of zolpidem.

Ellis Unger, a director in the FDA’s Center for Drug Evaluation and Research, urged patients to discuss the situation with doctors before changing any medication regime.

"We hope less of the drug will be in the bloodstream in the morning driving hours," Unger said in a conference call with reporters.

Before it faced generic competition, IMS Health said, two versions of Ambien had nearly $2 billion in sales in 2007 for drug maker Sanofi-Aventis, based in Paris, but with big operations in New Jersey and a site in Malvern, Chester County.

Teva Pharmaceuticals Ltd., which has big operations around Philadelphia, and Pittsburgh-based Mylan Pharmaceuticals are the two largest generic-drug-makers, and both list a generic version of zolpidem among their products.

Not all sleeping pills have zolpidem, but all FDA-approved drugs have label warnings about morning drowsiness. The agency said that extended-release forms of zolpidem showed the highest risk for next-morning impairment and that women were more susceptible than men because the drug often took longer to flush from their systems.

Usher said the agency was not influenced by various reports of celebrities who were using Ambien and had car accidents.

"The new information was not tied to any specific case," Usher said, without naming names. But he added, in reference to reports of celebrity accidents, "We don’t know the time of the accidents, we don’t know the last dosage, or whether there was alcohol or other drugs involved."


Contact David Sell at 215-854-4506 of, or follow on Twitter @phillypharma. Read his blog:


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Posted: January 2013