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Intermezzo(R) 3.5 mg Achieves Greater Early Bioavailability Than Ambien(R) 10 mg Despite 65% Lower Dose
Date:6/11/2008

Data Presented as Poster Presentation at the Associated Professional Sleep

Societies 2008 Annual Meeting

BALTIMORE, June 11 /PRNewswire/ -- Data was presented today at the 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS) demonstrating that within 20 minutes of administration, Intermezzo(R), an investigational low-dose, sublingual formulation of zolpidem, delivered overall bioavailability that was significantly greater than that produced by a swallowed Ambien(R) tablet containing a zolpidem dose that was nearly 3 times higher. Despite this higher initial bioavailability, zolpidem blood levels from sublingual 3.5 mg Intermezzo(R) were significantly lower four hours after administration than the levels produced by the 10 mg Ambien(R) dose. Transcept Pharmaceuticals is developing Intermezzo(R) for the treatment of insomnia characterized by middle-of-the-night (MOTN) awakenings with difficulty returning to sleep.

"One significant challenge in trying to help insomnia patients return to sleep after a middle-of-the-night awakening is that the most commonly prescribed bedtime medications are not designed to be taken as needed in the middle of the night without risking significant drowsiness the following day," said Thomas Roth, Ph.D., Chief of Sleep Medicine, Henry Ford Hospital Sleep Disorders and Research Center in Detroit and principal investigator in this study. "The only recourse to date for patients has been either to try to predict what nights they will awaken, or to take sleep medication every night at bedtime. Studies of Intermezzo(R) show promise in offering the first viable, 'use only when needed' option for treating awakenings in the middle of the night when they occur."

Intermezzo(R): Rapid bioavailability despite a lower dose

In the pharmacokinetic comparison study presented at APSS, 36 healthy subjects between the ages of 19 and 64 were randomized to receive either a 3.5 mg. Inte
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SOURCE Transcept Pharmaceuticals, Inc.
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