March 19, 2010 (FinancialWire) — Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) said that the U.S. Food and Drug Administration has approved the new drug application for its Silenor for the treatment of insomnia.

The company said that Silenor is approved for the treatment of both transient and chronic insomnia characterized by difficulty with sleep maintenance in both adults and elderly patients.

In clinical trials, Silenor demonstrated maintenance of sleep into the 7th and 8th hours of the night, with no meaningful evidence of next day residual effects, according to Somaxon.

The company added that Silenor has not been designated as a controlled substance by the U.S. Drug Enforcement Administration because of its demonstrated lack of abuse potential.

It also said that, in the Silenor clinical development program, no withdrawal effects or other adverse events were observed that were indicative of physical dependence.

California-based Somaxon Pharmaceuticals is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area.

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