SOMAXON REPORTS POSITIVE DATA ON INSOMNIA DRUG

Somaxon Pharmaceuticals has announced positive results from the company's Phase III clinical trial evaluating Silenor (doxepin HCl) in adults with transient insomnia. Silenor demonstrated statistically significant improvements compared with placebo in the primary endpoint of this trial, Latency to Persistent Sleep, a measure of sleep onset. Silenor also produced statistically significant improvements relative to placebo in multiple secondary endpoints, including measures of both sleep onset and sleep maintenance.

This trial was a randomized, double-blind, placebo-controlled, multicenter, parallel-group study that enrolled 565 adults in a sleep laboratory setting using a phase-advance, first-night assessment model of induced transient insomnia. Efficacy assessments evaluated both objective polysomnography and subjective measures of sleep. Results demonstrated that 6 mg of Silenor was effective at inducing sleep and maintaining sleep throughout the night.

Additionally, the drug achieved statistically significant results compared to placebo in Sleep Efficiency for the entire night and in each third of the night, as well as in subjective measures of sleep maintenance and Sleep Quality. The study also demonstrated that Silenor was well-tolerated. The incidence of adverse events was low and comparable to placebo. There were no reports of amnesia, memory impairment or anticholinergic effects, and there were no clinically meaningful effects on measures of next day impairment.