FDA Requires Lower Doses of Sleep Meds to Avoid Morning Drowsiness Injuries

The FDA is requiring makers of sleeping pills, such as Ambien, to lower the dosage of their drugs after finding that patients who take them face an increased risk of injury due to morning drowsiness.

According to the studies, the drugs can stay in the bloodstream long enough to interfere with morning driving and increasing the risk of car accidents. The FDA is ordering that the dose be cut in half for women, who process the drug more slowly. This would lower the dosage from 10 milligrams to 5 milligrams (or from 12.5 milligrams to 6.25 milligrams for extended-release formulas). This adjustment is also a recommendation, but not a requirement, for the dosage taken by men.

The new regulation applies to all sleep medications containing zolpidem, which is sold under the brand names Ambien, Edluar and Zolpimist.

The FDA said that doctors should aim to prescribe the lowest possible dose of the drug that will successfully treat insomnia.

Current patients should continue taking their prescribed dose until they can talk to their doctors about the best way to proceed.

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