51
Views
0
CrossRef citations to date
0
Altmetric
Drug Evaluation

Indiplon: a single compound in two formulations for the treatment of insomnia

Pages 259-268 | Published online: 21 Apr 2006

Bibliography

  • American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC, USA (2000).
  • American Sleep Disorders Association: The International Classification of Sleep Disorders Diagnostic and Coding Manual. Rochester, MN, USA (2001).
  • Ohayon M : Epidemiological study on insomnia in the general population. Sleep19(3 Suppl.), S7–S15 (1996).
  • Ancoli-Israel S , RothT: Characteristics of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. Sleep22, S347–S353 (1999).
  • Simon GE , VonKorffM: Prevalence, burden and treatment of insomnia in primary care. Am. J. Psychiatry154, 1417–1423 (1997).
  • Ford DE , KamerowDB: Epidemiologic study of sleep disturbances and psychiatric disorders. An opportunity for prevention?JAMA262, 1479–1484 (1989).
  • Monjan AA : Epidemiologic studies of sleep in aging. Paper presented at the 12th Annual Meeting of the Associated Professional Sleep Societies. New Orleans, LA, USA, June 19 (1998).
  • Lindberg E , JansonC, GislasonT, BjornssonE, HettaJ, BomanG: Sleep disturbances in a young adult population: can gender differences be explained by differences in psychological status?Sleep20(6), 381–387 (1997).
  • Klink ME , QuanSF, KaltenbornWTet al.: Risk factors associated with complaints of insomnia in a general adult population: influence of previous complaints of insomnia. Arch. Intern. Med.152, 1634–1637 (1992).
  • Breslau N , RothT, RosenthalLet al.: Sleep disturbance and psychiatric disorders: a longitudinal epidemiological study of young adults. Biol. Psychiatry39, 411–418 (1996).
  • Mellinger GD , BalterMB, UhlenhuthEH: Insomnia and its treatment: prevalence and correlates. Arch. Gen. Psychiatry42, 225–235 (1985).
  • Roth T , RoehrsT: Insomnia: epidemiology, characteristics, and consequences. Clin. Cornerstone5(3), 5–12 (2003).
  • Ohayon M , LemoineP, Arnaud-BriantV, DreyfusM: Prevalence and consequences of sleep disorders in a shift worker population. J. Psychosom. Res.53(1), 577–583 (2002).
  • Bastien CH , VallieresA, MorinCM: Precipitating factors of insomnia. Behav. Sleep Med.2, 50–62 (2004).
  • Jubber AS : Respiratory complications of obesity. Int. J. Clin. Pract.58(6), 573–580 (2004).
  • Kessler R , ChaouatA, SchinkewitchPet al.: The obesity-hypoventilation syndrome revisited. Chest120(2), 369–376 (2001).
  • Benca RM , Ancoli-IsraelA, MoldofskyH: Special considerations in insomnia diagnosis and management: depressed, elderly and chronic pain populations. J. Clin. Psychiatry.65(Suppl. 8), 26–35 (2004).
  • Bliwise D : Normal Aging. In: Principles and Practice of Sleep Medicine, Third Edition.KrygerMH, RothT, DementWC (Eds). WB Saunders Co., Philadelphia, PA, USA, 26–42 (2000).
  • Lindberg E , JansonC, GislasonT, BjornssonE, HettaJ, BomanG: Sleep disturbances in a young adult population: can gender differences be explained by differences in psychological status?Sleep20(6), 381–387 (1997).
  • Ballinger CB : Subjective sleep disturbance at the menopause. J. Psychosom. Res.20, 509–513 (1976).
  • Boyd JH , WeissmanMM: Epidemiology of affective disorders. A re-examination and future directions [review]. Arch. Gen. Psychiatry. 38, 1039–1046 (1981).
  • Roth T , Ancoli-IsraelS: Daytime consequences and correlates of insomnia in the United States: results of the 1991 National Sleep Foundation survey. Sleep22(Suppl. 2), S354–S358 (1999).
  • Rosenthal L , RoehrsTA, RosenAet al.: Level of sleepiness and total sleep time following various time in bed conditions. Sleep16, 226–232 (1993).
  • Zammit G : Insomnia interventions: new ideas for the management of sleep disorders. Clin. Geriatr. (July Suppl.), 11–13 (1999).
  • Balter MB , UhlenhuthEH: The beneficial and adverse effects of hypnotics. J. Clin. Psychiatry.52(Suppl.), 16–23 (1991).
  • Zammit GK , WeinerJ, DamatoNet al.: Quality of life in people with insomnia. Sleep22(Suppl. 2), S386–S393 (1999).
  • Johnson LC , SpinweberCL: Good and poor sleepers differ in navy performance. Mil. Med.148, 727–731 (1983).
  • Kupperman M , LubeckDP, MazonsonPDet al.: Sleep problems and their correlates in a working population. J. Gen. Intern. Med.10, 25–32 (1995).
  • Janson C , LindbergE, GislasonTet al.: Insomnia in men – a 10-year prospective population based study. Sleep24(4), 425–430 (2001).
  • Mallon L , BromanJE, HettaJ: Sleep complaints predicts coronary artery disease mortality in males: a 12-year follow-up study of a middle-aged Swedish population. J. Intern. Med.251, 207–216 (2002).
  • Gislason T , ReynisdottirH, Kristbjarnarson Het al.: Sleep habits and sleep disturbances among the elderly – an epidemiological survey.J. Int. Med.234(1), 31–39 (1993).
  • Haefely W , FacklamM, SchochPet al.: Partial agonists of benzodiazepine receptors for the treatment of epilepsy, sleep and anxiety disorders.Adv. Biochem. Psychopharmacol.47, 379–394 (1992).
  • Kales A , SoldatosCR, BixlerEO, KalesJD: Rebound insomnia and rebound anxiety: a review. Pharmacology26, 121–137 (1983).
  • Adams K , OswaldI: Can a rapidly-eliminated hypnotic cause daytime anxiety?Pharmacopsychiatry22, 115–119 (1989).
  • Bixler EO , KalesA, BurbakerBH, Kales JD: Adverse reactions to benzodiazepine hypnotics: spontaneous reporting system. Pharmacology35, 286–300 (1987).
  • Holbrook AM , CrowtherR, LotterA, ChengC, KingD: Meta-analysis of benzodiazepine use in the treatment of insomnia.CMAJ162(2), 225–233 (2000).
  • Bateson AN : The benzodiazepine site of the GABA-A receptor: an old target with new potential?Sleep Med.5(Suppl. 1), S9–S15 (2005).
  • Bateson AN : Basic pharmacologic mechanisms involved in benzodiazepine tolerance and withdrawal.Curr. Pharm. Des.8, 5–21 (2002).
  • Mendelson WB : Clinical distinctions between long-acting and short-acting benzodiazepines.J. Clin. Psychiatry.53(Suppl. 12), 4–9 (1992).
  • Vgontzas AN , KalesA, BixlerEO: Benzodiazepine side effects: role of pharmacokinetics and pharmacodynamics.Pharmacology51, 205–223 (1995).
  • Mendelson WB , JainB: An assessment of short-acting hypnotics.Drug Saf.13(4), 257–270 (1995).
  • Gillin JC , SpinweberCL, JohnsonLC: Rebond insomnia: a critical review.J. Clin. Psychopharmacol.9(3), 161–172 (1989).
  • Greenblatt DJ : Benzodiazepine hypnotics: sorting the pharmacodynamic facts.J. Clin. Psychiatry.52(Suppl.), 4–10 (1991).
  • Doghramji K : The need for flexibility in dosing hypnotic agents.Sleep23(Suppl. 1), S16–S20 (2000).
  • Rudolph U , CrestaniF, MohlerH: GABAA receptor subtypes: dissecting their pharmacological functions. Trends Pharmacol. Sci.22(4), 188–194 (2001).
  • Rudolph U , CrestaniF, BenkeDet al.: Benzodiazepine actions mediated by specific γ-aminobutyric acid (A) receptor subtypes.Nature401, 796–800 (1999).
  • McKernan RM , RosahlTW, ReynoldsDSet al.: Sedative but not anxiolytic properties of benzodiazepines are mediated by the GABAA receptor α1 subtype.Nature Neurosci.3, 587–592 (2000).
  • Walsh JK , SchweitzerPK, SugermanJL, MuehlbachMJ: Transient insomnia associated with a three-hour phase advance of sleeptime and treatment with zolpidem.J. Clin. Psychopharmacol.10, 184–189 (1990).
  • Scharf MB , RothT, VogelG, WalshJF: A multicenter placebo controlled study evaluating zolpidem in the treatment of chronic insomnia.J. Clin. Psychiatry.55(5), 192–199 (1994).
  • Walsh JK , FryJ, ErwinCWet al.: Efficacy and tolerability of 14-day administration of zaleplon 5 mg and 10 mg for the treatment of primary insomnia.Clin. Drug Invest.16, 347–354 (1998).
  • Fry J , ScharfM, ManganoRet al.: Zaleplon improves sleep without producing rebound effects in outpatients with insomnia.Int. Clin. Psychopharmacol.15, 141–152 (2000).
  • Nicholson AN , SchlosbergA, DreyfusJF: Zopiclone, a third-generation of hypnotics.Pharmacology27(Suppl. 2), 165–215 (1983).
  • Wyss PA , RadovanovicD, Meier-AbtPJ: Akute uberdosierungen mit zolpidem.Schweizer Med. Wochenschr.126, 750–756 (1996).
  • Hirai K , KatoK, NishiyamaKet al.: TAK-375 and its metabolites are selective agonists at ML-1 receptors.Sleep26(Suppl.), A79 (2003).
  • Brzezinski A : Melatonin in humans.N. Engl. J. Med.336, 186–195 (1997).
  • Erman M , SeidenD, ZammitGet al.: An efficacy, safety, and dose-response study of ramelteon in patients with chronic primary insomnia.Sleep Med.7, 17–24 (2006).
  • Griffiths R , SuessP, JohnsonM: Ramelteon and triazolam in humans: behavioral effects and abuse potential.Sleep28(Suppl.), A44 (Abstract 0132) (2005).
  • France C , WeltmanR, CruzC, McMahon L: Ramelteon does not have benzodiazepine agonist-like discriminative stimulus effects in normal or diazepam-dependant rhesus monkeys. Sleep28(Suppl.), A45 (Abstract 0133) (2005).
  • France C , WeltmanR, CruzC: Lack of primary physical dependence effects of ramelteon in rhesus monkeys.Sleep28(Suppl.), A45 (Abstract 0134) (2005).
  • Nishida N , SasakiM, WakasaYet al.: Reinforcing effect of ramelteon assessed by intravenous self-administration experiments in rhesus monkeys.Sleep28(Suppl.), A45 (Abstract 0135) (2005).
  • Foster AC , PelleymounterMA, CullenMJet al.: In vivo pharmacological characterization of indiplon, a novel pyrazolopyrimidlne sedative–hypnotic.J. Pharmacol. Exp. Ther.311(2), 547–559 (2004).
  • Rudolph U , CrestaniF, BenkeDet al.: Benzodiazepine actions mediated by specific γ-aminobutyric acid (A) receptor subtypes.Nature401, 796–800 (1999).
  • McKernan RM , RosahlTW, ReynoldsDSet al.: Sedative but not anxiolytic properties of benzodiazepines are mediated by the GABA(A) receptor α1 subtype.Nature Neurosci.3, 587–592 (2000).
  • Sullivan SK , PetroskiRE, VergeG, Gross RS, Foster AC, Grigoriadis DE: Characterization of the interaction of indiplon, a novel pyrazolopyrimidine sedative-hypnotic, with the GABAA receptor: Pharmacol. Exp. Ther.311(2), 537–546 (2004).
  • Petroski RE , PomeroyJE, DasRet al.: Indiplon is a high-affinity positive allosteric modulator with selectivity for {α} 1 subunit containing GABAA receptors: J. Pharmacol. Exp. Ther.317, 369–377 (2006).
  • Rogowski R , GarberM, BozigianH, JochelsonP, FarberR, CampbellB: NBI-34060 (a non-benzodiazepine sedative-hypnotic): lack of a pharmacokinetic gender effect:Sleep25(Suppl.), A415 (2002).
  • Jochelson P , RogowskiR, BurkeJet al.: The pharmacokinetics of the non-benzodiazepine sedative-hypnotic, NBI-34060 in elderly subjects.Sleep25(Suppl.), A415 (2002).
  • Rosen AS , FournieP, DarwishM, Danjou P, Troy SM: Zaleplon pharmacokinetics and absolute bioavailability. Biopharm. Drug Dispos.20, 171–175 (1999).
  • Greenblatt DJ , HarmatzJS, Von Moltke LLet al.: Comparative kinetics and response to the benzodiazepine agonist triazolam and zolpidem; evaluation of sex-dependent differences.J. Pharmacol. Exp. Ther.293, 435–443 (2000).
  • FDA Supervisory overview (NDA19–908), Zoplidem, 41–42 DHHS (1991).
  • Greenblatt DJ , HarmatzJS, ShaderRI: Clinical pharmacokinetics of antiolytics and hypnotics in the elderly.Clin. Pharmacokinet.21(4), 262–273 (1991).
  • Gailot J , Le Roux Y, Houghton GW, Dreyfus JF: Critical factors for the pharmacokinetics of zopiclone in the elderly and in patients with liver and renal insufficiency. Sleep10(Suppl. 1), 7–21 (1987).
  • Berkowitz DV , ScharfMB, JochelsonPet al.: The co-administration of indiplon (NBI-34060) and alcohol lacks pharmacokinetic and pharmacodynamic interaction.Sleep26(Suppl.), A81 (2003).
  • Jochelson P , ChenTK, FarberR, Campbell B: Lack of pharmacological and pharmacokinetic tolerance following repeat dosing of Indiplon (NBI-34060). Sleep26(Suppl.), A85–A86 (2003).
  • Roth T , WalshJK, RogowskiR: Farber R, Burke J, Jochelson P: Efficacy and tolerability of indiplon (NBI-34060) solution in healthy adults in a model on transient insomnia.Sleep26(Suppl.), A87 (2003).
  • Scharf MB , RothT, RosenbergR, Lankford DA, Alexander T: Efficacy and tolerability of indiplon IR in the treatment of transient insomnia. Sleep27(Suppl.), A267 (2004).
  • Walsh JK , RosenbergR, RothT, Lankford DA, Jochelson P: Treatment of primary insomnia for five weeks with indiplon-IR: Sleep27(Suppl.), A259 (2004).
  • Scharf MB Black J, Hull S et al. : Long term efficacy and tolerability of indiplon-IR in the treatment of chronic insomnia: results of a double-blind, placebo-controlled 3-month study.Sleep28(Suppl.), A229 (2005).
  • Neubauer D : Indiplon: the development of a new hypnotic.Expert Opin. Investig. Drugs14(10) 1269–1276 (2005).
  • Roth T , ZammitG, ScharfMB, BoydM, JochelsonP: Efficacy and safety of indiplon-IR in adults with chronic insomnia characterized by prolonged nighttime awakenings with difficulty returning to sleep.Sleep28(Suppl.), A229 (2005).
  • Scharf MB , RosenbergR, CohnMet al.: Safety and efficacy of immediate release indiplon (NBI-34060) in elderly patients with insomnia.Sleep26(Suppl.), A85 (2003).
  • Walsh JK , RothT, MoscovitchA, FarberR, JochelsonP: Efficacy and tolerability of indlplon-IR in elderly patients with primary insomnia.Sleep28(Suppl.), A229 (2005).
  • Jochelson P , BozigianH, GarberMet al.: The activity of modified release indiplon (NBI-34060) in a transient nighttime venipuncture model.Sleep26, (Suppl.) A84 (2003).
  • Jochelson P , ScharfM, RothT, WalshJK, GarberM: Efficacy of indiplon in inducing and maintaining sleep in patients with chronic sleep maintenance insomnia.Sleep27(Suppl.), A262 (2004).
  • Walsh JK , LankfordDD, KrystalAet al.: Efficacy and tolerability of four doses of indiplon (NBI-34060) modified-release in elderly patients with sleep maintenance insomnia.Sleep26, (Suppl.) A78 (2003).
  • Lankford J , LydiardR, WalshJK, 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. Sleep28(Suppl.), A230 (2005).
  • Hull S , FogartyC, VinceB, ChediakAD, JochelsonP, GatelyN: Safety of indiplon-MR in patients with mild-to-moderate COPD.Sleep27(Suppl.), A261 (2004).
  • Garber M , BurkeJ, FarberR, JochelsonP, CampbellB: Residual effects of middle of the night dosing: a placebo-controlled crossover study of indiplon-IR, zolpidem, and zolpiclone in healthy volunteers.Sleep27(Suppl.), A260 (2004).

Websites

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:

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:

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.