Friday, January 11, 2013

FDA Wants Lower Dosage Recommendations for Zolpidem

The Food and Drug Administration (FDA) announced that it is requiring manufacturers of widely used sleep medications that contain zolpidem to lower current recommended dosages. The ruling will affect manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist. 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.

The FDA 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 said that the labeling should recommend that health care professionals consider prescribing these lower dosages (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are available in both the higher and lower dosages.

Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. “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, M.D., 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.”

Ruth Benca, M.D., a professor of psychiatry and director of the sleep center at the University of Wisconsin School of Medicine, said the ruling is appropriate. “We have always known that zolpidem is a bit more potent in women than in men,” she told Psychiatric News. “It doesn’t mean that everyone should automatically cut their dose if they are doing okay with what they are taking, but clinically it is always good practice to start low and prescribe the lowest dose that is effective.”

For more information on treating sleep problems, see American Psychiatric Publishing's Clinical Manual for Evaluation and Treatment of Sleep Disorders. For purchasing information click here.

(Image: Warren Goldswain/


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