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Marp2
Posts: 1,320
Registered: ‎01-31-2012

FDA requires lower doses for sleep medications

‎01-10-2013 04:42 PM

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 said Thursday that new research shows that the drugs remain in the bloodstream at levels high enough to interfere with morning 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. Doses will be lowered from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations.

The FDA is recommending that manufacturers apply these lower doses to men as well, though it is not making them a requirement.

The new doses apply to all insomnia treatments containing the drug zolpidem, which is sold under brands including Ambien, Intermezzo and Zolpimist.

http://news.yahoo.com/fda-requires-lower-doses-sleep-medications-153619863--finance.html

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