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January 11, 2013
05:02 EDTTSPTTranscept Pharmaceuticals comments on FDA dosage reduction for Zolpidem
The FDA is requiring that the manufacturers of certain zolpidem based prescription sleep aids such as Ambien and Ambien CR, and generic versions of these products, reduce the recommended dose. FDA has informed the manufacturers of these products that the recommended dose of zolpidem at bedtime for women should be lowered from 10 mg to 5 mg for immediate-release products such as Ambien, and from 12.5 mg to 6.25 mg for extended-release products such as Ambien CR. FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses 5 mg for immediate-release products and 6.25 mg for extended-release products. "We are pleased that this action by FDA confirms the recommended dose of Intermezzo at 3.5 mg in men and 1.75 mg in women for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep, so long as they have at least 4 hours of remaining bedtime," stated Glenn A. Oclassen, president and CEO of Transcept.
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