The Medical Letter on Drugs and Therapeutics
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FDA Requires Lower Dosing of Zolpidem

On January 10, 2013, the FDA issued a news release to announce that it was requiring the manufacturers of the zolpidem-containing products Ambien, Ambien CR, Edluar and Zolpimist, which are all approved for treatment of insomnia, to lower the doses for women and to recommend in their labeling consideration of a lower dose for men.1 No change will be required in the dose of Intermezzo, a low-dose sublingual formulation of zolpidem for middle-of-the-night awakening, which is already recommended in a lower dose for women.2

New Data – Driving simulation and laboratory studies recently submitted to the agency indicate that zolpidem serum concentrations >50 ng/mL can seriously impair driving performance. In pharmacokinetic studies, 8 hours after taking 10 mg of Ambien, 15% of women and 3% of men had ... more      

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