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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

pproved PRN ("use only when needed") treatment for MOTN insomnia.

"The prevalence and impact of nocturnal awakenings may require significant adjustments in how we define, diagnose and treat insomnia, which is currently approached in a one-size-fits-all fashion due to the limitations of available therapies," said Dr. Roth, who participated in a June 2008 APSS symposium convened to discuss the prevalence and consequences of nocturnal awakenings.

A Potential New Approach for Patients with Middle of the Night Awakenings

In a related APSS poster presentation, investigators described a study in which they sought to quantify the proportion of MOTN insomnia patients who would be suitable candidates for treatment with a rapidly effective and short-acting agent. Investigators monitored 654 patients participating in an insomnia clinical trial using an Interactive Voice Response System (IVRS) that patients called each night after a middle of the night awakening. This system tracked the time of awakenings and amount of bedtime remaining.

Of the original group, 300 met the study criteria and were verified to suffer from MOTN awakenings with difficulty returning to sleep. These patients experienced a weekly average of 5.2 such awakenings and more than 90 percent of these awakenings occurred with at least four hours of bedtime remaining.

"Nearly all patients in this study experienced frequent awakenings at a time of night when they had at least four hours of sleep remaining. Thus, they would be appropriate candidates for treatment with a rapid-acting, low-dose medication," said Russell Rosenberg, Ph.D., principal study author and Director, NeuroTrials Research and the Atlanta School of Sleep Medicine. "The study underscored the potential for Intermezzo(R) to be useful in a patient population such as this."

About Zolpidem

To date, zolpidem has been available in the United States as the active agent in Ambien(R) and Ambien CRTM, prescr
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SOURCE Transcept Pharmaceuticals, Inc.
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