Insomnia isn’t just the inability to go to sleep. Sufferers may finally drift into slumber, only to wake up too early and be unable to go back to sleep. They may also wake frequently during the night. These symptoms, termed sleep maintenance difficulty, are the most common symptom of insomnia.
This week, the U.S. Food and Drug Administration approved Somaxon Pharmaceutical’s Silenor for the treatment of insomnia with sleep maintenance difficulty. According to Richard Pascoe, president and CEO of Somaxon, Silenor the first sleep aid that hasn’t been deemed a controlled substance. Silenor is a low-dose formulation of doxepin, a medication typically used to treat depression and anxiety. In clinical trials, Silenor demonstrated sleep maintenance at 7 and 8 hours of sleep. No abuse or withdrawal effects, both common concerns among patients, were observed. Shares in Somaxon more than doubled following the announcement.
According to the FDA, about 40 million people in the U.S. suffer from sleep disorders. Demand for sleep aids is strong and will likely continue to increase over the next few years. Somaxon is part of a crowded market that includes competition (and potential competition) from NovaDel, Vanda Pharmaceuticals, Neurogen, and Transcept Pharmaceuticals. NovaDel was one of the presenters at the 2010 OneMedForum. Their presentation can be viewed here.