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Indiplon (INN and USAN) is a nonbenzodiazepine, hypnotic sedative being developed in 2 formulations - an immediate release product for sleep onset and a modified-release version for sleep maintenance.
Mode of action
Indiplon is said to work by enhancing the action of the inhibitory neurotransmitter GABA, like most other nonbenzodiazepine sedatives. It primarily binds to the α1 subunits of the GABAA receptors in the brain.
Indiplon was originally scheduled for release to doctors and pharmacies sometime in 2007, most likely in the springtime of that year, which is when Sanofi-Aventis' popular sleep aid, zolpidem, lost its patent rights in the United States and thus became available to patients as a much less expensive generic. Neurocrine Biosciences had planned to comarket indiplon in the US with Pfizer. However, following the issuing of a nonapprovable letter for the modified-release 15 mg formulation and an approvable letter (with stipulations) for the 5 mg and 10 mg immediate-release version by the FDA (May 2006), Pfizer decided to end its relationship with Neurocrine.
On December 13, 2007, Neurocrine announced that the FDA deemed their new drug application (NDA) 'approvable'. The 2007 Approvable Letter does not reference the setbacks seen previously in the May 2006 Approvable Letter, bringing the availability of indiplon one step closer to the consumer.
The planned brand name has not yet been revealed to the public. The NDA was initially approved by the FDA in 1998, and since then, Neurocrine has been conducting clinical trials, with purportedly satisfactory results.
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- "Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA" (Press release). Neurocrine Biosciences, Inc.. 2007-12-13. http://www.drugs.com/nda/indiplon_071213.html. Retrieved 2007-12-13.