Pharmacy Daily | Changing US sleep patterns

THE manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, are being forced to lower the current recommended doses in the US. The move by the US Food and Drug Administration will see changes in both branded and generic sleep aids containing zolpidem, with the agency informing 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 extendedrelease 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. The change in dosage recommendations follows the release of new data which shows 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,” the FDA said. “Data show the risk for nextmorning impairment is highest for patients taking the extendedrelease 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 nextmorning impairment for activities that require complete mental alertness, including driving,” the FDA added. Meanwhile, for those already taking higher doses (10 mg or 12.5 mg) of zolpidem-containing insomnia medicines, the FDA has advised them to keep with their prescribed dose, until they discuss how they can safely continue to take their medicine with their GP.

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