The data presented was from a Phase 3 development program, made up of four Phase 3 trials that evaluated SILENOR in low dose formulation. The Phase 3 program showed positive results. Patients experienced significant improvements in sleep onset, sleep maintenance, and the prevention of early morning awakenings, while the side effect profile reported for SILENOR was comparable to placebo. Additionally, there were no reports of amnesia or complex sleep behaviors reported, and no next-day residual effects were found.
“While several prescription products for the treatment of insomnia have become available in recent years, we believe that a need remains for a medication that helps people fall asleep and say asleep throughout the night without next-day residual effects or risk of dependence,” says David F. Hale, Somaxon’s executive chairman. “SILENOR can be an attractive treatment alternative for physicians and the insomnia patients they treat, if it is approved by the FDA.”