The US Food and Drug Administration is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses.
New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours.
Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men.
Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.
The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 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.
"To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient's insomnia," said Ellis Unger, MD, director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research. "Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate."
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