FDA Recommends Reducing Doses of Sleep Drugs Containing Zolpidem

January 16, 2013

The current recommended doses of popular sleep drugs Ambien, Ambien CR, Edluar, and Zolpimist must be reduced, the US Food and Drug Administration (FDA) informed the drugs’ manufacturers. The change in labeling is based on new data showing that zolpidem, the active ingredient in all of the targeted drugs, may remain in the blood of some patients the next morning and could impair alertness in driving and other daily activities.

The new recommendations take into account gender differences in eliminating zolpidem from the bloodstream. For women, who eliminate zolpidem more slowly than men, the recommended dosage of zolpidem will change from 10 mg to 5 mg for immediate-release products such as Ambien, Edluar, and Zolpimist and from 12.5 mg to 6.25 mg for extended-release products such as Ambien CR. For men, drug labeling should suggest that health care providers consider prescribing the same lower doses indicated for women, the FDA said.

To reduce the possibility of impairment, clinicians are encouraged to prescribe the lowest dose capable of treating the patient’s insomnia, said Ellis Unger, MD, Director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.

The FDA also issued a Drug Safety Communication cautioning that morning drowsiness is a common side effect of all insomnia drugs, not just those containing zolpidem. Even people who do not feel impaired may experience reduced alertness the day after taking a sleep drug. However, the FDA noted that each patient and situation is unique and that the appropriate dose should be discussed with a health care professional.

  —Lauren LeBano



1.  FDA requiring lower recommended dose for certain sleep drugs containing zolpidem [press release]. Silver Spring, MD; January 10, 2013.

2.   US Food and Drug Administration. Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist). Silver Spring, MD: US Food and Drug Administration; 2013.         

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