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FDA recommends lower zolpidem doses for women

Thursday January 10, 2013
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The Food and Drug Administration has issued new recommendations regarding dosages of zolpidem, a widely prescribed insomnia drug.

The FDA said the bedtime dose should be lowered for women because new data show blood levels in some may be high enough during the morning after use to impair activities that require alertness, including driving.

The announcement focuses on zolpidem products approved for bedtime use, which are marketed under the brand names Ambien, Ambien CR, Edluar and Zolpimist.

Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of the drugs, namely Ambien CR and generics. Women appear to be more susceptible to this risk because they eliminate zolpidem form their bodies more slowly than men.

Because use of lower doses of zolpidem will result in lower blood levels in the morning, the FDA is requiring the manufacturers to lower the recommended dose for women — from 10 milligrams 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).

The labeling should include a recommendation for clinicians to consider a lower dose for men as well, according to the FDA.

For zolpidem and other insominia drugs, clinicians should prescribe the lowest dose that treats the patient’s symptoms and should inform patients that impairment from sleep drugs can be present despite feeling fully awake.

"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," Ellis Unger, MD, a director in the FDA’s Center for Drug Evaluation and Research, said in a news release.

"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 noted that the recommended doses of Intermezzo, a lower-dose zolpidem product approved for middle-of-the-night awakening, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men.

The FDA is continuing to evaluate the risk of impaired mental alertness in other insomnia drugs, including over-the-counter drugs available without a prescription.

More information about the zolpidem recommendation is available on a frequently asked questions page at http://www.fda.gov/Drugs/DrugSafety/ucm334041.htm.


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