Somaxon Pharmaceuticals Inc. got approval for its insomnia drug Silenor after three tries from the FDA. The company had initially sent their drug application as early as January, 2008 which eventually got declined. Somaxon resubmitted its application on January 21, 2010, which was considered as Class 1 resubmission with a two-month review cycle resulting in a decision date by March 21, 2010.
Silenor has not been designated as a controlled substance by the U.S. Drug Enforcement Administration because of its demonstrated lack of abuse potential. Silenor works by selectively blocking histamine that assists people in staying awake. The drug’s ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential is what made it stand out as a safe insomnia drug which many sleep-deprived people are sure to want to try out.
(Source) RTT News
