FDA requires lower doses for sleeping pills

Federal regulators will require drug companies to cut the recommended doses for sleeping pills, saying the drugs cause lingering problems like the inability to safely drive a car.

The Food and Drug Administration (FDA) announced Thursday that it will require lower doses for drugs including Ambien, Edluar and Zolpimist. The drugs share the same active ingredient, which can cause morning-after drowsiness that interferes with the ability to drive safely.

The recommended dose for female patients must drop from 10 milligrams to five, the FDA said. Extended-release products, which use a higher dose over a longer period of time, must also cut their recommended doses in half for women, the FDA said.

The agency also encouraged doctors to consider writing prescriptions for the lower dose for all patients.

“Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their healthcare professional about whether their sleep medicine is appropriate," the FDA's Ellis Unger said in a statement.

The FDA said recent studies have shown the sleep aids remain in the bloodstream the next morning, in quantities large enough to impair driving and similar tasks. That increases the risk of car accidents.

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