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Indiplon
Systematic (IUPAC) name
N-methyl-N-[3-[3-(thiophene-2-carbonyl)
pyrazolo[5,1-b]pyrimidin-7-yl]phenyl]acetamide
Identifiers
CAS number 325715-02-4
ATC code none
PubChem 6450813
Chemical data
Formula C20H16N4O2S 
Mol. mass 376.0993
Therapeutic considerations
Pregnancy cat.  ?
Legal status Schedule IV (US)
Routes Oral

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.

Contents

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.[1]

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 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.[citation needed]

On December 13, 2007, Neurocrine announced that the FDA deemed their new drug application (NDA) 'approvable'.[2] 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.[2]

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. ^ Petroski RE, Pomeroy JE, Das R, et al. (April 2006). "Indiplon is a high-affinity positive allosteric modulator with selectivity for alpha1 subunit-containing GABAA receptors" (PDF). J. Pharmacol. Exp. Ther. 317 (1): 369–77. doi:10.1124/jpet.105.096701. PMID 16399882. http://jpet.aspetjournals.org/cgi/content/full/317/1/369. 
  2. ^ 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. http://www.drugs.com/nda/indiplon_071213.html. Retrieved 2007-12-13. 

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