Transcept Pharmaceuticals Announces FDA Approval of Intermezzo For Use as Needed for the Treatment of Insomnia
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that the U.S. Food and Drug Administration has approved Intermezzo C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
Middle-of-the-night awakening with difficulty falling back to sleep is a form of insomnia that is estimated to affect millions of adults in the United States. Intermezzo is the first and only prescription sleep aid indicated for dosing in the middle of the night to treat this form of insomnia.
Intermezzo is formulated as a sublingual tablet containing a bicarbonate-carbonate buffer. Intermezzo is rapidly absorbed in both women and men. The recommended dose of Intermezzo for non-elderly patients is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. These recommended doses are specific to each gender because women clear zolpidem from the body at a lower rate than men. The 1.75 mg dose is recommended for patients over the age of 65. The recommended doses of other FDA approved zolpidem products range between 5 mg and 12.5 mg and are indicated for bedtime use.
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