Indiplon

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.

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Mode of action

Indiplon is said to work by enhancing the action of the inhibitory neurotransmitter GABA, like most other nonbenzodiazepine sedatives. Its primary function is to bind to BZ₁ and Alpha₁ subunits of the GABA-_A receptors in the brain.

Availability

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 15mg formulation and an approvable letter (with stipulations) for the 5mg and 10mg immediate-release version by the FDA (May 2006), Pfizer decided to end its relationship with Neurocrine.^{[citation needed]}

On December 13, 2007, Neurocrine announced that the FDA deemed their new drug application (NDA) 'approvable'.^[1] 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.^[1]

The planned brand name has not yet been revealed to the public. The NDA was initially approved by the FDA in 1998,^{[citation needed]} and since then, Neurocrine has been conducting clinical trials, with purportedly satisfactory results.^{[citation needed]}

References

1. ^ ^{a b} Neurocrine Biosciences, Inc. (2007-12-13). "Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA". Press release. Retrieved on 2007-12-13.