If you use any sleep aids, the FDA may be changing your dosage. The administration released a statement Thursday saying it 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. And doses may be different for men and women..
Women eliminate zolpidem from their bodies more slowly than men, the FDA told 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 who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.
Ellis Unger, M.D., director, Office of Drug Evaluation in the FDA's Center for Drug Evaluation and Research says, “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. 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.”
For more on the recommendations read here.
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