· Log in

Silenor approved by the FDA for insomnia treatment

Written by: David Castillo on March 23rd, 2010

Silenor approved by the FDA for insomnia treatment | read this item

Somaxon Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor, a treatment for insomnia.

The new drug has been approved as a treatment for short term and long term insomnia in adults and elderly individuals. In its clinical trials, Silenor demonstrated maintenance into seventh and eight hours of the night without evidence of residual effects during day time.

“The approval of Silenor represents an important milestone for Somaxon and will allow us to provide physicians and patients with a highly differentiated treatment option for insomnia,” explained Richard W. Pascoe, Somaxon’s president and chief executive officer. “We believe that Silenor’s ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential uniquely positions Silenor for commercial success.”

Pascoe continued: “Looking forward, we will continue to execute on our business strategy, focusing on seeking a US commercial partnership, building a US commercial presence and preparing to launch Silenor in the second half of 2010.”

Experts say that the maintenance of insomnia has important implications in a patient’s overall health. Silenor promotes good sleep habits for insomnia patients.

somaxon-pharmaceuticals