Indiplon is a novel
sedative-
hypnotic recently approved for the treatment of
insomnia. Like other non-
benzodiazepine hypnotics, its mechanism of action is to modulate subunits, especially the alpha-1 subunit, of the
GABA receptor complex in order to induce sedation.
Indiplon was developed in two different formulations to address two different types of
insomnia complaint:
indiplon-IR (immediate release) was designed for sleep onset difficulties, while
indiplon-MR (modified release) was developed for sleep maintenance
insomnia. While there are currently few peer reviewed articles about
indiplon clinical trial results, the early information that is available seems to indicate that both formulations have been well tolerated and have proven effective at improving both patient reported and objectively measured sleep parameters in both adult and elderly
insomnia patients. In May 2006, the FDA indicated that
indiplon-IR was approvable and plans are to resubmit the application in 2007.
Indiplon-MR was unapprovable and may require further evaluation.