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FDA: Lower Ambien's Dose to Prevent Drowsy Driving
Date:1/11/2013

y."

It's not clear why women eliminate the substance from their bodies more slowly than men.

Although there have been reports of adverse events, including motor vehicle accidents possibly related to zolpidem, the link has not and probably cannot be definitely established, Unger said.

The changes were spurred by new driving-simulation studies showing that currently prescribed levels of drugs containing zolpidem may be high enough to impair alertness the next day, he explained.

The FDA will be requiring driving-simulation studies for new sleep medications, and it is assessing other insomnia medications on the market. Eventually, Unger said, "we want driving data on all sleep medications."

Unger emphasized that next-day impairment is not limited to medications containing zolpidem but to all sleep medications.

"For all sleep medications, doctors should prescribe and patients should take the lowest dose," he said.

People taking any kind of sleep medication should not change their dose without first talking to their health-care professional, he stressed.

More information

Visit the U.S. Food and Drug Administration for more about next-morning impairment.

SOURCE: Jan. 10, 2013, news conference with Ellis Unger, M.D., director, Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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