Drug Makers Ordered to Lower Sleep Aid Doses

The FDA today announced that it is ordering drug makers to reduce the recommended doses for all sleep aids containing the active ingredient zolpidem.  The U.S. government agency cited concerns about how long the drug stays in the user’s blood system, saying it could cause drowsiness the next morning and could impair activities that require alertness, including driving.

Manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, all of which contain zolpidem, were given the following guidelines, according to an FDA news release:

The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 milligrams (mg) to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are currently available on the market in both the higher and lower dosages.

People who are currently taking the higher doses (10 mg or 12.5 mg) of zolpidem-containing insomnia medicines should continue taking the prescribed dose as directed until discussing with their health care professional how to safely continue to take the medicine.

The labeling change is based on findings in driving simulation and laboratory studies showing that, in some individuals, zolpidem blood levels the morning after use appear capable of impairing driving to a degree that increases the risk of a motor vehicle accident.

“Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” said Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”

The FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (nonprescription) drugs.

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