FDA requires lower doses for sleep meds
WASHINGTON -- 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 yesterday that new research shows the drugs remain in the bloodstream at levels high enough to interfere with alertness and coordination, which increases the risk of car accidents.
Regulators are ordering manufacturers to cut the dose of the medications in half for women, who process it more slowly.
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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, Edluar, Zolpimist and in generic forms. It is the most widely prescribed sleeping aid in the United States.
The changes don't affect other popular sleeping medicines like Lunesta and Sonata, which use different drugs.
FDA officials pointed out that all sleeping drugs carry warnings about drowsiness.
"All sleep drugs have the potential to cause this, so health professionals should prescribe -- and patients should take -- the lowest dose that is capable of preventing insomnia," said Dr. Ellis Unger, a director in the FDA's Office of Drug Evaluation, on a teleconference with reporters.
Unger added that the FDA will begin requiring developers of sleep drugs to conduct driving simulation studies going forward.
The FDA has received more than 700 reports of driving-related problems connected to zolpidem over the years.
"But in most cases it was very difficult to determine if the driving impairment was actually related to zolpidem," Unger said. "Usually the reports did not contain information about when the accident happened or how much time had lapsed since taking the drug."