90
Views
30
CrossRef citations to date
0
Altmetric
Drug Evaluation

Zaleplon - a review of a novel sedative hypnotic used in the treatment of insomnia

Pages 841-858 | Published online: 24 Feb 2005

Bibliography

  • FRANCES A: Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). American Psychiatric Association (1994)553–557.
  • KARACAN I, THORNBY JI, ANCH M et al.: Prevalence of sleep disturbance in a primarily urban Florida county. Soc. Sci. Med. (1976) 10:239–244.
  • BIXLER EO, KALES A, SOLDATOS C: Prevalence of sleep disorders in the Los Angeles metropolitan area. Am. J. Psychiatry (1979) 136:1257–1262.
  • LUGARESI E, ZUCCONI M, BIXLER EO: Epidemiology of sleep disorders. Psychiatr. Ann. (1987) 17:446–453.
  • BECKER PM, JAMIESON AO, BROWN WD: Insomnia. Use of a decision tree to assess and treat. Postgrad. Med. (1993) 93:66–85.
  • FORD DE, KAMEROW DB: Epidemiologic study of sleep disturbances and psychiatric disorders. An opportu-nity for prevention? J. Am. Med. Assoc. (1989) 262:1479–1484.
  • WALSH JK, ENGELHARDE CL: Trends in the pharma-cologic treatment of insomnia. J. Clin. Psychiatry (1992) 53\(Suppl. 12):510–517.
  • JOHNSON C, CHERNIK DA: Sedative hypnotics and human performance. Psychopharmacology (1982) 76:101–113.
  • KALES A, SOLDATOS CR, BIXLER E, KALES J: Rebound insomnia and rebound anxiety: a review. Pharma-cology (1983) 26:121–137.
  • MENDELSON WB: Medications in the treatment of sleep disorders. In: Psychopharmacology: the Third Generation of Progress. Meltzer HY, Coyle JT, Kopin IJ (Eds.) Raven Press, New York, USA (1987):163–172.
  • Approved labelling for Zaleplon (Sonata, Wyeth-Ayerst): Physician's Desk Reference 54th Edition. (2000):3319–3323.
  • GAUDREAULT J, VARIN F, POLLACK GM: Pharmacoki-netics and anticonvulsant effect of a new hypnotic, CL 284,846, in rats. Pharmaceutical Res. (1995) 12:1592–1597.
  • BEER B, CLODY DE, MANGANO R, LEVNER M, MAYER P, BARRETT JE: A review of the preclinical development of zaleplon, a novel non-benzodiazepine hypnotic for the treatment of insomnia. CNS Drug Reviews (1997) 3:207–224.
  • ••An excellent overview of the in vitro and in vivo pharma-cology of zaleplon.
  • DAY IP, CLODY DE, MONAGHAN MM, ABEL MS, DUSZA JP, BEER B: Pharmacology of CL 284,846, a non-benzodiazepine sedative with reduced amnestic liability. Soc. Neurosci. (1992) 18:725(Abstract).
  • VANOVER KE, BARRETT JE: Evaluation of the discrimi-native stimulus effects of the novel sedative-hypnotic CL 284,846. Psychopharmacology (1994) 115:289–296.
  • ••Results from discriminative stimulus studies with zaleplon.
  • SANGER DJ, MOREL E, PERRAULT G: Comparison of the pharmacological profiles of the hypnotic drugs, zaleplon and zolpidem. Eur. J. Pharmacol. (1996) 313:35–42.
  • ••Results of a comparison of zaleplon and zolpidem in variousin vivo models.
  • SANGER DJ: The effects of new hypnotic drugs in rats trained to discriminate ethanol. Behav. Pharmacol (1997) 8:287–292.
  • GRANT KA: Emerging neurochemical concepts in the actions of ethanol at ligand gated ion channels. Behav. Pharmacol. (1994) 5:383–404.
  • FILE SE: Tolerance to the behavioral actions of benzodi-azepines. Neurosci. Biobehav. Rev. (1985) 9:113–121.
  • GARRATT JC, GENT JP, FEELY M, HAIGH JRM: Can benzodiazepines be classified by characterising their anticonvulsant tolerance-inducing potential? Eur. J. Pharmacol. (1988) 145:75–80.
  • PERRAULT G, MOREL E, SANGER DJ, ZIVKOVIC B: Lack of tolerance and physical dependence upon repeated treatment with the novel hypnotic zolpidem. J. Pharmacol. Exp. Ther. (1992) 263:298–303.
  • PERRAULT G, MOREL E, SANGER DJ, ZIVKOVIC B: Repeated treatment with alpidem, a new amdolytic, does not induce tolerance or physical dependence. Neuropharmacology (1993) 32:855–863.
  • COX A, BOYLAND P, GENT JP, FEELY M: An investigation of anti-convulsant tolerance to zolpidem in mice. Br. J. Pharmacol (1988) 95:667P.
  • GRIEBEL G, PERRAULT G, SANGER DJ: Limited anxiolytic-like effects of non-benzodiazepine hypnotics in rodents. J. Psychopharmacol. (1998) 12:356–365.
  • GRIEBEL G, BLANCHARD D, JUNG A, BLANCHARD R: Amodel of `antipredator' defense in Swiss-Webster mice: effect of benzodiazepine receptor ligands with different intrinsic activities. Behav. Pharmacol (1995) 6:732–745.
  • VANOVER KE, MANGANO RM, BARRETT JE: CL 284,846, anovel sedative-hypnotic - evaluation of its metabolites for pharmacological activity in vitro and in vivo. Drug Dev. Res. (1994) 33:39–45.
  • ROSEN AS, FOURNIE P, DARWISH M, DANJOU P, TROYSM: Zaleplon pharmacokinetics and absolute bioavail-ability. Biopharm. Drug Dispos. (1999) 20:171–175.
  • RENWICK AB, MISTRY H, BALL SE, WALTERS DG, KAO J,LAKE BG: Metabolism of zaleplon by human hepatic microsomal cytochrome P450 isoforms. Xenobiotica (1998) 28:337–348.
  • KAWASHIMA K, HOSOI K, NARUKE T, SHIBA T, KITAMURA M, WATABE T: Aldehyde oxidase-dependent marked species difference in hepatic metabolism of the sedative-hypnotic, zaleplon, between monkeys and rats. Drug Metab. Dispos. (1999) 27:422–428.
  • •Demonstration of the difference in metabolism of zaleplon in rats versus monkeys.
  • CHAUDHARY I, DEMAIO W, KANTROWITZ J: Species comparison of in vitro and in vivo metabolism of CL 284,846, a non-benzodiazepine sedative/hypnotic agent. Pharm. Res. (1994) 11:319.
  • DARWISH M, MARTIN P, CEVALLOS W, TSE S, WHEELERS,TROY S: Rapid disappearance of zaleplon from breast milk after oral administration to lactating women. J. Pharmacol. (1999) 39:670–674.
  • GONZALEZ FJ, CRESPI CL, GELBOIN HV: cDNA-expressed human cytochrome P450s: a new age of molecular toxicology and human risk assessment. Mutation Res. (1991) 247:113–127.
  • BEER B, IENI JR, WU W et al: A placebo-controlledevaluation of single, escalating doses of CL 284,846, a non-benzodiazepine hypnotic. J. Clin. Pharmacol. (1994) 34:335–344.
  • •Results from a Phase I pharmacokinetic/pharmacodynamic study with zaleplon.
  • TALLLAND GA: Effects of alcohol on performance in continuous attention tasks. Psychosomatic Med. (1966) 28:596–604.
  • WESNES K, WARBURTON DM: Effects of smoking on rapid information processing performance. Neuropsy-chobiology (1983) 9:223–229.
  • HINDMARCH I, PARROTT AC: A repeated dose comparison of the side effects of five antihistamines on objective assessments of psychomotor perform-ance, central nervous system arousal and subjective appraisals of sleep and early morning behavior. Arzneimit-Forchung (Drug Research) (1978) 28:483–486.
  • HINDMARCH I, SUBHAN Z, STOKER MJ: The effects of zimelidine and amitriptyline on car driving and psychomotor performance. Acta Psychiatr. Scand. (1983) 308:141–146.
  • GREENBLATT DJ, HARMATZ JS, VON MOLTKE LL et al:Comparative kinetics and dynamics of zaleplon, zolpidem and placebo. Clin. Pharmacol Ther. (1998) 64:553–561.
  • ALLEN D, CURRAN HV, LADER M: The effects of singledoses of CL 284,846, lorazepam and placebo on psychomotor and memory function in normal male volunteers. Eur. J. Clin. Pharmacol (1993) 45:313–320.
  • ALLEN D, LADER M: The interactions of ethanol withsingle and repeated doses of suriclone and diazepam on physiological and psychomotor functions in normal subjects. Eur. J. Clin. Pharmacol. (1992) 42:499–505.
  • FREWER LJ, LADER M: The effects of caffeine on two computerised tests of attention and vigilance. Human Psychopharmacol (1991) 6:119–128.
  • ALLEN D, BAYLAV A, LADER M: A comparative study of the interaction of alcohol with alpidem, lorazepam and placebo in normal subjects. Int. Clin. Psychophar-macol. (1988) 3:327–341.
  • ALLEN D, CURRAN HV, LADER M: The effects of repeated doses of clomipramine and alprazolam on physio-logical, psychomotor and cognitive functions in normal subjects. Eur. J. Clin. Pharmacol. (1991) 40:355–362.
  • BADDELEY AD: A 3 minute reasoning test based ongrammatical transformation. Psychosom. Sci. (1968) 10:341–342.
  • SHEPERD RN, MELTZER J: Mental rotation of three dimensional objects. Science (1971) 171:701–703.
  • DANJOU P, PATY I, FRUNCILLO R et al.: A comparison of the residual effects of zaleplon and zolpidem following administration 5 to 2 h before awakening. Br. J. Clin. Pharmacol. (1999) 48:367–374.
  • VERMEEREN A, DANJOU PE, O'HANLON JF: Residual effects of evening and middle-of-the-night administra-tion of zaleplon 10 mg and 20 mg on memory and actual driving performance. Hum. Psychopharmacol Clin. Exp. (1998) 13:S98–5107.
  • KAPTEYN TS, BLES W, NJIOKIKTREN CJ, KOODE L, MASSEN CH, MOL JM: Standardization in platform stabilometry being part of posturography. Aggresso-logie (1983) 24:321–326.
  • O'HANLON JF, RAMAEKERS JG: Antihistamine effects on actual driving performance in a standard test: a summary of the Dutch experience 1989-1994. Allergy (1995) 50:234–242.
  • O'HANLON JF, VERMEEREN A, UITERWIJK MMC, VAN VEGGEL LMA, SWIJGMAN HF: Anxiolytics' effects on actual driving performance of patients and healthy volunteers in a standardized test. Neuropsychobiology (1995) 31:81–88.
  • RAMAEKERS JG, UITERWIJK MMC, O'HANLON JF: Effects of loratadine and cetirizine on actual driving and psychometric test performance and EEG during driving. Eurj Gun. Pharmacol. (1992) 42:363–369.
  • VUURMAN EFPM, MUNTJEWERFF ND, UITERWIJK MMC et al.: Effects of mefloquine, alone and with alcohol, on psychomotor and driving performance. Eur. j Clin. Pharmacol. (1996) 50:475–482.
  • SAKAMOTO T, UCHIMURA N, MUKAI M, MIZUMA H, SHIRAKAWA S, NAKAZAWA Y: Efficacy of L-846 in patients with insomnia: Evaluation by polysom-nography. Psychiatry Clin. Neurosci. (1998) 52:156–157.
  • WALSH JK, FRY J, ERWIN CW, SCHARF M, ROTH T, VOGEL GW: Efficacy and tolerability of 14-day administration of zaleplon 5 mg and 10 mg for the treatment of primary insomnia. Clin. Drug Invest. (1998) 16:347–354.
  • ••Results from a 14 day placebo-controlled multicentre studywith zaleplon in 132 patients.
  • ELIE R, RUTHER E, FARR I, EMILIEN G, SALINAS E: Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel non-benzodiazepine hypnotic. J. Clin. Psychiatry (1999) 60:536–544.
  • ••Results from a 28 day placebo- and zolpidem-controlledstudy with zaleplon in 574 patients.
  • TYRER P, MURPHY S, RILEY P: The Benzodiazepine Withdrawal Sleep Questionnaire. J. Affective Disord. (1990) 19:53–61.
  • RUSH CR, FREY JM, GRIFFITHS RR: Zaleplon and triazolam in humans: acute behavioral effects and abuse potential. Psychopharmacology (1999) 145:39–51.
  • •An evaluation of the abuse potential of zaleplon in subjects with a history of drug abuse.

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.