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February 4, 2008

SILENOR -- A Sleeper among Hypnotics

Analysis of: Somaxon Pharmaceuticals Submits New Drug Application For SILENOR(TM) For The Treatment Of Insomnia | www.pipelinereview.com

This analysis is solely the work of the author. It has not been edited or endorsed by GLG.

Analysis By:

Daniel Wynn, MD
Director, Clinical Research, Consultants In Neurology Ltd.

Implications: Somaxon Pharmaceuticals has submitted a NDA for Silenor for the treatment of insomnia. The active ingredient is doxepin, which has been available for years.The effect of the drug can be expected to be very modest, side effects unfavorable when compared to Ambien or Lunesta, and with both significant potential side effects and drug interactions. The introduction of this sleeper puts me to sleep. I doubt that I would ever prescribe it. given its disadvantages, I do not see Somaxon's goal.

Analysis: Histamine binding, the mechanism of action of this drug, can be expected to cause weight gain, a side effect which would keep patients from taking this medication. This is already a problem with other histamine binding antidepressants such as Remeron and Paxil

The chemical structure of the drug would predict danger if taken in combination with several medications or alcohol, unfortunately the most commonly taken hypnotic.

The effect of this drug on long term sleep maintenance versus sleep onset (time to persistent sleep) would be expected to be very short, if existent at all.

There are too many more effective, safer hypnotics on the market today to make this drug attractive to physicians or patients.

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