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FDA requires lower doses for sleep medications
Posted: Jan 10, 2013 9:07 AM by Associated Press
WASHINGTON (AP) - The Food and Drug Administration is requiring makers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting patients face a higher risk of injury due to morning drowsiness.
The agency says new research shows that the widely-used sleeping drugs remain in the blood at levels high enough to interfere with driving, which increases the risk of car accidents.
Regulators are ordering drug manufacturers to cut the dose of the medications in half for women, who process the drug more slowly. The FDA is also recommending that manufacturers use the lower doses for men, though it will not be mandatory.
The new doses apply to all insomnia treatments containing the drug zolpidem, which is sold under the brands Ambien, Edluar and Zolpimist.
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