WASHINGTON — The Food and Drug Administration on Thursday ordered 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 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.
Regulators are requiring drug manufacturers to cut the dose in half for women, who process the drug more slowly. Doses will be loweredto 5 milligrams for regular products and 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.
The FDA has received more than 700 reports of driving-related problems connected to zolpidem over the years.