Relaxing before going to bed will help a person fall asleep faster. Learning to substitute pleasant thoughts for unpleasant ones (imagery training) is a technique that can be very helpful in reducing worry. Another effective measure is the use of audiotapes that combine the sounds of nature with soft relaxing music. These, alone or in combination with other relaxation techniques, can safely promote sleepiness.

Changes in diet and exercise routines can also have a beneficial effect. Dietary items to be avoided include drinks that contain caffeine, such as coffee, tea and colas'chocolate (which contains a stimulant); and alcohol, which initially makes a person sleepy but a few hours later can have the opposite effect. Maintaining a comfortable bedroom temperature, reducing noise and eliminating light are also helpful. Regularly scheduled morning or afternoon exercise can relax the body. This should be done 3-4 times a week and be sufficient to produce a light sweat.

Somaxon Pharmaceuticals Announces FDA Feedback on Silenor OTC Regulatory Pathway





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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