Mental Health

FDA Lowers Ambien Dosage to Prevent Sleep-Driving Risks

By Staff Reporter | Update Date: Jan 10, 2013 06:06 PM EST

The Food and Drug Administration is requiring the makers of certain sleep-inducing drugs, including Ambien, to reduce the current recommended dose of the medications after they have show to impair activities.

The agency said Thursday that new research shows that the drugs remain in the bloodstream at levels high enough to interfere with alertness and coordination, which increases the risk of car accidents.
The new requirement applies to sleep-inducing drugs that contain the active ingredient zolpidem, which is found in drugs such as Ambien, Ambien CR, Edluar and Zolpimist. Sanofi markets Ambien, but the products are also available in generic versions, the FDA said.

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 sleeping drugs are widely prescribed, with almost 40 million prescriptions written in the U.S. in 2011, according to information provider IMS Health.

Ambien and other drugs containing zolpidem are considered sedative-hypnotic drugs and are designed to treat insomnia by helping people fall and stay asleep. The drugs are meant for short-term use although the exact length of treatment isn't defined in the drugs' labels.

The FDA today said that it is also examining the effects of other sleep medications, and will require companies to do driving studies to determine if different dosing is needed for those medications as well.

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