FDA Approves Lower Doses For Sleep Aids

Law360, New York (May 14, 2013, 6:51 PM EDT) -- The Food and Drug Administration said Tuesday that it had approved labeling changes recommending lower doses for sleep aids containing zolpidem, such as Sanofi SA's Ambien, which can stay in a patient's bloodstream at high levels into the next day, making it dangerous to drive.

The changes incorporate lower dosing recommendations for women that the FDA made in January, and affect Ambien and Ambien CR, as well as Meda AB's Edluar. The new dosing recommendations for immediate release zolpidem are 5 milligrams for women and 5...
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