FDA calls for lower dosage in some insomnia drugs

Agency requires drug makers to lower recommended dosage in products with zolpidem

SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.

According to the agency's recommendation, the dosage for women should be lowered from 10 mg to 5 mg for immediate-release drugs and from 12.5 mg to 6.25 mg for extended-release formulations. For men, doctors should consider prescribing these lower doses, the FDA said. The higher and lower doses are both currently available on the market.

"To decrease the potential risk of impairment with all insomnia drugs, healthcare professionals should prescribe, and patients should take, the lowest dose capable of treating the patient's insomnia," FDA Office of Drug Evaluation I director Ellis Unger said. "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."

Zolpidem is the active ingredient of Sanofi's Ambien and Ambien CR, Meda Pharmaceuticals' Edluar and NovaDel Pharma's Zolpimist, as well as several generics.


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