1:38AM Transcept Pharma comments on new FDA Dosage reduction requirements for Zolpidem based prescription sleep aids administered at bedtime (TSPT) 5.76 : 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.
The FDA announcement further states, "The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo's approval in November 2011, the label already recommended a lower dosage for women than for men." Co states: "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."
