Advanced search
Publication Cover
Expert Opinion on Investigational Drugs Volume 14, 2005 - Issue 10
Submit an article Journal homepage
83
Views
22
CrossRef citations to date
0
Altmetric
Drug Evaluation

Indiplon: the development of a new hypnotic

David N Neubauer Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, Suite A-456, Baltimore, MD 21224, USA. [email protected]
Pages 1269-1276 | Published online: 27 Sep 2005

Bibliography

  • NEUBAUER DN: Understanding Sleeplessness: Perspectives on Insomnia. Johns Hopkins University Press, Baltimore (2003).
  • OHAYON MM, ROTH T: Place of chronic insomnia in the course of depressive and anxiety disorders. J. Psychiatr. Res. (2003) 37:9–15.
  • FORD DE, KAMEROW DB: study of sleep disturbances and psychiatric disorders. An opportunity for prevention?JAMA (1989) 262:1479–184.
  • MENDELSON WB, ROTH T, CASSELLA J et al.: The treatment of chronic insomnia: drug indications, chronic use and abuse liability. Summary of a 2001 clinical drug evaluation unit meetingsymposium. Sleep Med. Rev (2004) 8:7–17.
  • ADIS INTERNATIONAL LIMITED: Indiplon. Indiplon modified-release, indiplon MR, NBI 34060, NBI 34060 modified-release, NBI 34060 MR. Drugs R&D (2002) 3:197–199.
  • FOSTER AC, PELLEYMOUNTER MA, CULLEN MJ et al.: LI vivo pharmacological characterization of indiplon, a novel pyrazolopyrimidine sedative-hypnotic. I Phannacol Exp. Ther. (2004) 311(2):547–559.
  • ••A detailed presentation of indiplon'spharmacological characteristics in animal models with a focus on the pharrnacodynamic actions related to sedative-hypnotic effects.
  • SULLIVAN SK, PETROSKI RE, VERGE G, GROSS RS, FOSTER AC, GRIGORIADIS DE: Characterization of interaction of indiplon, a novel pyrazolopyrimidine sedative-hypnotic, with the GABAA receptor. J. Phannacol Exp. Ther. (2004) 311(2):537–546.
  • ••A detailed presentation of indiplon'spharmacological characteristics in animal models with a focus on the interactions at the GABAA receptor complex.
  • PETROSKI RE, POMEROY JE, DAS R et al: Indiplon: A positive allosteric modulator of native and recombinant GABAA receptors. Society for Neuroscience2004 Abstract Vieweatinery Planner. DC USA. (2004) (Program No. 160.7).
  • JOCHELSON P, CHEN TK, FARBER R, CAMPBELL B: Lack of pharmacological and pharmacokinetic tolerance following repeat dosing of indiplon (NBI-34060). Sleep (2003) 26:A85-A86 (Abstract supplement).
  • FISHER D, YUAN Z, JIN L et al.: LI vitro metabolism of NBI-34060 (indiplon) and its potential to inhibit P450 enzymes. Drug Metab. Rev (2002) 34\(Suppl. 1):171.
  • BERKOWITZ DV, SCHARF MB, JOCHELSON P et al: The co-administration of indiplon (NBI-34060) and alcohol lacks pharmacokinetic and pharmacodynamic interaction. Sleep (2003) 26:A81 (Abstract supplement).
  • ROGOWSKI R, GARBER M, BOZIGIAN H, JOCHELSON P, FARBER R, CAMPBELL B: NBI-34060 (a non-benzodiazepine sedative-hypnotic): lack of a pharmacokinetic gender effect. Sleep (2002) 25:A415 (Abstract supplement).
  • JOCHELSON P, ROGOWSKI R, J et al.: The pharmacokinetics of the non-benzodiazepine sedative-hypnotic, NBI-34060 in elderly subjects. Sleep (2002) 25:A415-A416 (Abstract supplement).
  • ROTH T, WALSH JK, ROGOWSKI R, FARBER R, BURKE J, JOCHELSON P: Efficacy and tolerability of indiplon (NBI-34060) solution in healthy adults in a model on transient insomnia. Sleep (2003) 26:A87 (Abstract supplement).
  • SCHARF MB, ROTH T, R, LANKFORD DA, ALEXANDER T: Efficacy and tolerability of indiplon IR in the treatment of transient insomnia. Sleep (2004) 27:A267 (Abstract supplement).
  • WALSH JK, ROSENBERG R, ROTH T, LANKFORD DA, JOCHELSON P: Treatment of primary insomnia for five weeks with indiplon-IR. Sleep (2004) 27:A259 (Abstract supplement).
  • SCHARF MB, ROSENBERG R, M et al.: Safety and efficacy of immediate release indiplon (NBI-34060) in elderly patients with insomnia. Sleep (2003) 26:A85 (Abstract supplement).
  • WALSH JK, ROTH T, A, FARBER R, JOCHELSON P: Efficacy and tolerability of indiplon-IR in elderly patients with primary insomnia. Sleep (2005) 28:A229 (Abstract supplement).
  • SCHARF MB, BLACK J, HULLS et al.: Long term efficacy and tolerability of indiplon-IR in the treatment of chronic: results of a double-blind, placebo-controlled 3-month study. Sleep (2005) 28:A229 (Abstract supplement).
  • ROTH T, ZAMMIT G, SCHARF MB, BOYD M, JOCHELSON P: Efficacy and safety of indiplon-IR in adults with chronic insomnia characterized by prolonged nighttime awakenings with difficulty returning to sleep. Sleep (2005) 28:A229 (Abstract supplement).
  • JOCHELSON P, BOZIGIAN H, GARBER M et al.: The activity of modified release indiplon (NBI-34060) in a transient nighttime venipuncture model. Sleep (2003) 26:A84 (Abstract supplement).
  • JOCHELSON P, SCHARF M, ROTH T, WALSH JK, GARBER M: Efficacy of indiplon in inducing and maintaining sleep in patients with chronic sleep maintenance insomnia. Sleep (2004) 27:A262 (Abstract supplement).
  • WALSH JK, LANKFORD DD, A et al.: Efficacy and tolerability of four doses of indiplon (NBI-34060) modified-release in elderly patients with sleep maintenance insomnia. Sleep (2003) 26:A78 (Abstract supplement).
  • LANKFORD J, LYDIARD R, WALSH JK, SEIDEN D, JOCHELSON P: Efficacy and tolerability of indiplon-MR in elderly patients with chronic insomnia: results of a double-blind, placebo-controlled, 2-week trial. Sleep (2005) 28:A230 (Abstract supplement).
  • COHN M, JOCHELSON P, GATELY N, BARON C, BOYD M: Assessment of respiratory effects of indiplon-MR in a CO2 challenge model. Sleep (2004) 27:A261 (Abstract supplement).
  • HULLS, FOGARTY C, VINCE B, CHEDIAK AD, JOCHELSON P, GATELY N: Safety of indiplon-MR in patients with mild-to-moderate COPD. Sleep (2004) 27:A261 (Abstract supplement).
  • GARBER M, BURKE J, FARBER R, JOCHELSON P, CAMPBELL B: Residual effects of middle of the night dosing: a placebo-controlled crossover study of indiplon-IR, zolpidem, and zolpiclone in healthy volunteers. Sleep (2004) 27:A260 (Abstract supplement).

Websites

  • www.neurocrine.com/ar03/indiplon.htm Neurocrine Biosciences 2003 annual report.
  • http://phx.corporate-innet/ phoenix.zhtml?c=68817&p=IROL-secToc&TOC=aHROcDovL2NjYm4uMT Brd216YXJkLmNvbS94bWvvvY29udGVud HMueGlsP21wYWd1PTMyNzc2MzImcm Vwbz1OZW5r Biosciences securities and exchange commission form 10-K for the fiscal year ended December 31, 2004 (dated 16/02/05).
  • www.dovpharm.com DOV Pharmaceutical website.
  • http://phx.corporate-innet/ phoenix.zhtml?c=68817&p=irol-newsArticle&ID=613315 &highlight= Press release 1/18/02, Neurocrine announces positive Phase II efficacy and safety results with indiplon MR.
  • http://phx.corporate-innet/ phoenix.zhtml?c=68817&p=irol-newsArticle&ID=675569 &highlight= Press release 16/02/05, Neurocrine reports positive Phase III efficacy and safety results with indiplon MR tablets in treating adult patients with chronic insomnia.
  • http://phx.corporate-innet/ phoenix.zhtml?c=68817 &p=irol-newsArticle&ID=613212 &highlight= Press release 24/03/04, Neurocrine's 'SLEEP' study demonstrates highly positive long-term efficacy results with indiplon MR.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.