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Clinical Study of Intermezzo(R) for the Treatment of Middle of the Night Awakening Published in SLEEP
Date:10/22/2008

somnia and a history of prolonged middle of the night awakenings. Subjects were randomized to receive 1.75 mg or 3.5 mg doses of Intermezzo(R), or a placebo, over three 2-night treatment periods.

The study results demonstrated that Intermezzo(R) 1.75 mg and 3.5 mg doses, when taken at the time of a middle of the night awakening, significantly shortened the time for patients to return to sleep as compared to placebo and there was no evidence of next morning residual effects. Patients taking Intermezzo(R) 3.5 mg also had statistically significant improvements in post-dose total sleep time, sleep efficiency, subjective number of awakenings and sleep quality. Morning questionnaires also revealed improvements in the level of refreshed sleep and next day ability to function compared to placebo.

Dr. Roth commented, "This study supports the safety and efficacy of Intermezzo(R) for the treatment of middle of the night awakenings at the time they occur. The most commonly prescribed sleep medications are intended to be taken at bedtime and they produce sleep for seven to eight hours after dosing. Such medications can be used at bedtime to prevent an awakening later in the night, but the patient must either anticipate which nights an awakening may occur, or take a seven to eight hour sleep aid every night. The results of this study suggest that low dose sublingual zolpidem (Intermezzo(R)) may offer patients a fast acting low-dose alternative that can be taken only when it is really needed at the time of an awakening, and which provides rapid return to sleep without the risk of residual sedation the following morning."

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, remarked, "We congratulate Dr. Roth and his colleagues on the publication in SLEEP. Along with our Phase 3 outpatient study, Dr. Roth's sleep-lab study serves as the foundation for the Intermezzo(R) New Drug Application we recently submitted to the U.S. Food and Drug Admini
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SOURCE Transcept Pharmaceuticals, Inc.
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