This multi-center, placebo-controlled phase III clinical trial will evaluate the safety and efficacy of Silenor over a three month period in elderly patients diagnosed with primary chronic insomnia.
The primary goal of the trial is Wake After Sleep Onset (WASO), the sleep maintenance endpoint recommended by the FDA. Multiple secondary efficacy endpoints will be evaluated, both objectively and through patient-reported outcomes.
“We hope to demonstrate a significant improvement in a variety of measures of insomnia in the Silenor phase III clinical trials in elderly patients,” stated Ken Cohen, Somaxon’s president and CEO. “In addition, and importantly, the active ingredient in Silenor is non-addictive and therefore, unlike all products currently approved to treat insomnia characterized by difficulty maintaining sleep, it is not a Schedule IV controlled substance.”