FDA Orders Cuts To Sleep-Aid Dosages Over Car Crash Risks

Law360, New York (January 10, 2013, 2:57 PM EST) -- The U.S. Food and Drug Administration on Thursday directed Sanofi-Aventis US LLC and other makers of insomnia drugs containing zolpidem to halve the recommended dosage for women, saying the increased drowsiness they may feel the morning after usage could make driving dangerous.

The agency is requiring drugmakers to lower the recommended dosage on labeling for Ambien and other bedtime-use, zolpidem-containing drugs from 10 milligrams to 5 mg for women taking immediate-release versions and from 12.5 to 6.25 mg for women taking extended-release versions. The labeling should...
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