Sleep is essential for mental and physical restoration. It is a cycle with two separate states: rapid eye movement (REM), the stage in which most dreaming occurs; and non-REM (NREM). Four stages of sleep take place during NREM: stage I, when the person passes from relaxed wakefulness; stage II, an early stage of light sleep; stages III and IV, which are increasing degrees of deep sleep. Most stage IV sleep (also called delta sleep), occurs in the first several hours of sleep. A period of REM sleep normally follows a period of NREM sleep.

Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX), a specialty pharmaceutical company, announced that it recently had a meeting with the U.S. Food & Drug Administration (FDA) relating to the over-the-counter (OTC) development program for Silenor®. In the meeting, which Somaxon attended jointly with its Silenor partner Procter & Gamble, the FDA provided clinical and regulatory guidance that the company believes provides a clear path forward toward an OTC version of Silenor.

Somaxon believes that the FDA’s guidance provides an opportunity to develop an OTC label that is tailored to Silenor’s clinical profile and differentiated from other OTC sleep products. Somaxon believes that Silenor’s characteristics, including its lack of addiction potential and its clinical efficacy and safety profile, make it an ideal candidate to be the first prescription insomnia product to be converted to an OTC product.



Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded products and late-stage product candidates to treat important medical conditions where there is an unmet medical need and/or high-level of patient dissatisfaction, currently in the central nervous system therapeutic area. Somaxon’s product Silenor, now available by prescription in the United States, is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

For more information, please visit the company’s web site at www.somaxon.com.

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