Indiplon
Encyclopedia
Indiplon 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.
, like most other nonbenzodiazepine sedatives. It primarily binds to the α1 subunits of the GABAA receptors in the brain.
' 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.
Neurocrine's website is currently stating that they have discontinued development of indiplon in the United States, raising doubts about whether it will ever be brought to market.
Nonbenzodiazepine
The nonbenzodiazepines, also called benzodiazepine-like drugs, are a class of psychoactive drugs pharmacologically resembling the benzodiazepines, with similar benefits, side effects and risks, despite having dissimilar or entirely different chemical structures.-Classes:There are currently three...
, hypnotic
Hypnotic
Hypnotic drugs are a class of psychoactives whose primary function is to induce sleep and to be used in the treatment of insomnia and in surgical anesthesia...
sedative
Sedative
A sedative or tranquilizer is a substance that induces sedation by reducing irritability or excitement....
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 GABAGabâ
Gabâ or gabaa, for the people in many parts of the Philippines), is the concept of a non-human and non-divine, imminent retribution. A sort of negative karma, it is generally seen as an evil effect on a person because of their wrongdoings or transgressions...
, like most other nonbenzodiazepine sedatives. It primarily binds to the α1 subunits of the GABAA 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-AventisSanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
' popular sleep aid, zolpidem
Zolpidem
Zolpidem is a prescription medication used for the short-term treatment of insomnia, as well as some brain disorders. It is a short-acting nonbenzodiazepine hypnotic of the imidazopyridine class that potentiates gamma-aminobutyric acid , an inhibitory neurotransmitter, by binding to GABAA...
, lost its patent rights in the United States and thus became available to patients as a much less expensive generic. Neurocrine Biosciences
Neurocrine Biosciences
Neurocrine Biosciences is a biopharmaceutical company founded in 1992 and located in San Diego, California. The company tooks its name from the original focus on therapies for neurological and endocrine diseases and disorders....
had planned to comarket indiplon in the US with Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
. 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
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
decided to end its relationship with Neurocrine.
On December 13, 2007, Neurocrine announced that the FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
deemed their new drug application
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
(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.
Neurocrine's website is currently stating that they have discontinued development of indiplon in the United States, raising doubts about whether it will ever be brought to market.