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Effects of hypnotics on sleep quality and daytime well-being. Data from a comparative multicentre study in outpatients with insomnia

Published online by Cambridge University Press:  16 April 2020

G Hajak ,
P Clarenbach ,
W Fischer ,
W Haase ,
B Bandelow ,
L Adler  and
E Rüther
G Hajak
Affiliation:
Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075Göttingen, Germany
P Clarenbach
Affiliation:
Department of Neurology, Evangelisches Johannes-Krankenhaus, Bielefeld, Germany
W Fischer
Affiliation:
Rhone-Poulenc Rarer GmbH, Köln, Germany
W Haase
Affiliation:
Institute for Numeric Statistic, Köln, Germany
B Bandelow
Affiliation:
Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075Göttingen, Germany
L Adler
Affiliation:
Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075Göttingen, Germany
E Rüther
Affiliation:
Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075Göttingen, Germany
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Summary

The effect of treatment (28 days) with zopiclone, triazolam, flunitrazepam and placebo on sleep quality and daytime well-being was proven in a randomised, double-blind, parallel group, multicentre study in private practice. Results of an exploratory statistic of treatment efficacy in a subgroup of 1,291 patients suffering from insomnia are presented. Patients met the following criteria: insomnia lasting at least four weeks and the presence of at least two of the following: 1) sleep latency ≥ 45 minutes, 2) total sleep time ≤ 6 hours, and 3) nocturnal awakening ≥3 times. Treatment efficacy was assessed according to the following factors: either a shortening of sleep latency by at least 15 minutes, or prolongation of total sleep time by at least 20%, or reduction of the number of nocturnal awakenings to three or less and a refreshed feeling in the morning as well as no impairment in daytime well-being due to tiredness or anxiety. The total response rate was markedly higher with zopiclone (42.3%; p = 0.0003) than with placebo (29.0%). Triazolam (36.6%; p = 0.0905) and flunitrazepam (33.1%; p = 0.3401) were also more effective than the placebo, but they both tended to have a lower response rate than with zopiclone (p = 0.1199 and 0.0151, respectively). Total response was found to be essentially a reflection of the response of the socially important parameter of daytime well-being. These results suggest that zopiclone is more effective in the treatment of insomnia than either triazolam or flunitrazepam. Since the response of daytime well-being to therapy was generally poor, this parameter embodies the next main therapeutic challenge in the treatment of patients with insomnia.

Keywords

zopicloneflunitrazepamtriazolaminsomniasleep disorderhypnotics
Type
Research Article
Information
European Psychiatry , Volume 10 , Issue S3: Satellite Symposium to the AEP Congress , 1995 , pp. 173s - 179s
Copyright
Copyright © Elsevier, Paris 1995

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References

Adam, KOswald, ICan a rapidly-eliminated hypnotic cause daytime anxiety. Pharmacopsychiatry 1989;22:115–19CrossRefGoogle ScholarPubMed
American Psychiatric Association Diagnostic and statistic manual of mental disorders. Fourth edition (DSM-IV) Washington DC: APA, 1994Google Scholar
Anderson, AAZopiclone and nitrazepam: a multicenter placebo-controlled comparative study of efficacy and tolerance in insomnia patients in general practice. Sleep 1987; 10(suppl 1):54–62CrossRefGoogle ScholarPubMed
Autret, EMaillard, FAutret, AComparison of the clinical hypnotic effects of zopiclone and triazolam. Eur J Clin Pharmacol 1987;31:621–3CrossRefGoogle ScholarPubMed
Billiard, MBesset, ALustrac De, CBrissaud, LDose-response effect of zopiclone on night-time and daytime functioning. Sleep 1987; 10(suppl 1):27–34CrossRefGoogle Scholar
Bixler, EOKales, ALeo, LASlye, ECA comparison of subjective estimates and objective sleep laboratory findings in insomniac patients. J Sleep Res 1973;2:143Google Scholar
Bond, ALader, MAfter-effects of sleeping drugs. In: Wheatley, D ed. Psychopharmacology of sleep New York: Raven, 1991 177–7Google Scholar
Carskadon, MABrown, EDement, WCSleep fragmentation in the elderly: relationship to daytime sleep tendency. Neurobiol Aging 1982;3:321–327CrossRefGoogle ScholarPubMed
Carskadon, MADement, WCMitler, MMGuilleminault, CZarcone, VPSpiegel, RSelf-reports versus sleep laboratory findings in 122 drug-free subjects with complaints of chronic insomnia. Am J Psychiatry 1976;133:1382–8Google ScholarPubMed
Chaudoir, PJBodkin, NLO'Donell, JAnderson, AHolland, RLA comparative study of zopiclone and triazolam in patients with insomnia. Int Clin Psychopharmacol 1990; 5(suppl 2):21–7Google ScholarPubMed
Dement, WCSeidel, WCarskadon, MADaytime alertness, insomnia and benzodiazepines. Sleep 1982;5:528–45CrossRefGoogle ScholarPubMed
Dement, WCSeidel, WCarskadon, MAIssues in the diagnosis and treatment of insomnia. Psychopharmacologysuppl 11984 11–43Google ScholarPubMed
Elie, RFrenay, MLe Morvan, PBourgouin, JEfficacy and safety of zopiclone and triazolam in the treatment of geriatric insomniacs. Int Clin Psychopharmacol 1990; 5(suppl 2):39–46Google ScholarPubMed
Fleming, JAMcClure, DJMayes, CPhillips, RBourgouin, JA comparison of the efficacy, safety and withdrawal effects of zopiclone and triazolam in the treatment of insomnia,. Int Clin Psychopharmacol 1990; 5(suppl 2):29–37Google Scholar
Folkard, SShiftwork and performance in 24-hour workday: proceedings of a symposium on variations in sleep-work schedules.DMSS Publication Number (NIOSH) Washington DC: US Government Printing Office, 1981 81–127Google Scholar
Fontaine, RBeaudry, PLe Morvan, PBeauclair, LChouinard, GZopiclone and triazolam in insomnia associated with generalized anxiety disorder: a placebo controlled evaluation of efficacy and daytime anxiety. Int Clin Psychopharmacol 1990;5:173–83CrossRefGoogle ScholarPubMed
Ford, DEKamerow, DBEpidemiologic study of sleep disturbances psychiatric disorders. An opportuity for prevention. JAMA 1989;262:1479–84CrossRefGoogle Scholar
Goa, KLHeel, RCZopiclone. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy as a hypnotic.Updated version from Drugs 1986, 32. Auckland: Adis Drug Information Services, 1991 48–65Google Scholar
Hajak, GClarenbach, PFischer, WHaase, WRüther, EZopiclone improves sleep quality and daytime well-being in insomniac patients: comparison with triazolam, flunitrazepam and placebo. Int Clin Psychopharmacol 1994;9:251–261CrossRefGoogle ScholarPubMed
Hajak, GRüther, E ed. Insomnie Berlin, Heidelberg: Springer, 1995CrossRefGoogle Scholar
Harrison, CSubhan, ZHindmarch, IResidual effects of zopiclone and benzodiazepine hypnotics on psychomotor performance related to car driving. Drugs Exp Clin Res 1985;11:823–9Google ScholarPubMed
Hindmarch, IAssessment of daytime psychomotor performance and memory effects of hypnotic drugs. JAMA 1993; 9(suppl 1):13–20Google Scholar
Hindmarch, IHuman phannalogical differences betweeen benzodiazepines. In: Hindmarch, IBeaumont, GBrandon, SLeonard, BE ed. Benzodiazepines: current concepts. Biological, clinical and social perspectives Chichester: Wiley, 1990 73–109Google Scholar
ICSD — International classification of sleep disorders diagnostic and coding manual Rochester, Minnesota: American Sleep Disorders Association, 1990Google Scholar
Johnson, LCSpinweber, CLQuality of sleep and performance in the Navy: a longitudinal study of good and poor sleepers. In: Guilleminault, CLugaresi, E eds. Sleep/wake disorders. Natural history, epidemiology and long-term evolution New York: Raven, 1983 13–28Google Scholar
Kales, ABixler, EOVela-Bueno, ACadieux, RJSoldatos, CFKales, JDBiopsychobehavioral correlates of insomnia. III: Polygraphic findings of sleep difficulty and their relationship to psychopathology. Int J Neurosci 1984;23:43–56CrossRefGoogle ScholarPubMed
Kales, AKales, JD ed. Evaluation and treatment of insomnia New York: Oxford University Press, 1984Google Scholar
Klimm, HDDreyfus, JFDelmotte, MZopiclone versus nitrazepam: a double-blind comparative study of efficacy and tolerance in elderly patients with chronic insomnia. Sleep 1987; 10(suppl 1):73–8CrossRefGoogle ScholarPubMed
Lader, MDenney, SCA double-blind study to establish the residual effects of zopiclone on performance of healthy volunteers. Pharmacology 1983; 27(suppl 2):98–108CrossRefGoogle ScholarPubMed
Lassen, E ed. A randomized, double-blind cross-over mukicentre study comparing zopiclone 7.5 mg and flunitrazepam 1 ing in the treatment of insomniac patients World Federation of Sleep Research Societies, Founding Congress, 1991 Abstract 340Google Scholar
Martikainen, KHasan, JUrponen, HVuori, IPartinen, MDaytime sleepiness: a risk factor in community life. Acta Neurol Scand 1992;86:337–41CrossRefGoogle ScholarPubMed
Baiter, MBUhlenhut, EHInsomnia its treatment. Prevalence and correlates. Arch Gen Psychiatry 1985;42:225–32Google Scholar
Mendelson, WB ed. The use and misuse o sleeping pills. A clinical guide New York: Plenum, 1980CrossRefGoogle Scholar
Miller, MMCarskadon, MACzeisler, CADement, WCCatastrophes sleep public policy. Consensus report. Sleep 1988; 11: 100–09Google Scholar
Monchesky, TCBillings, BJPhillips, RZopiclone: a new non-benzodiazepine hypnotic used in general practice. Clin Therap 1986; 8: 283–91Google Scholar
Moon, CALAnkier, SIHayes, GEarly morning insomnia and day-time anxiety —a multicentre general practice study comparing loprazolam and triazolam. BrJ Clin Practice 1985;39(9):352–8Google Scholar
Moon, CALHindmarch, IHolland, RLThe effect of zopiclone 7.5 mg on the sleep, mood and performance of shift workers. Int Clin Psycliopliarmacol 1990; 5(suppl 2):79–84Google ScholarPubMed
Mouret, JRuel, DMaillard, FBianchi, MZopiclone versus triazolam in insomniac geriatric patients: a specific increase in delta sleep with zopiclone. Int Clin Psychopharmacol 1990; 5(suppl 2):47–55Google ScholarPubMed
Musch, RMaillard, FZopiclone, the third generation hypnotic: a clinical overview. Int Clin Psychopharmacol 1990; 5(suppl 2):147–58Google ScholarPubMed
National Institute of Mental Health (NIMH) Consensus Development Conference Drugs and insomnia: the use of medications to promote sleep JAMA 1984;251:2410–14CrossRefGoogle Scholar
National Institute of Mental Health Clinical global impressions In: Collegium Internationale Psychatriae Scalarum Internationale Skalen für Psychiatrie Weinheim: Beltz, 1986Google Scholar
Ott, HOswald, lFichte, KSastre-Y-Hernandez, MVisuelle Analogskalen zur Erfassung der Schlafqualitt. In: Collegium Internationale Psychatriae Scalarum, ed. Internationale Skalen für Psychiatrie Weinheim: Beltz, 1986Google Scholar
Roth, TRoehrs, TCarskadon, MDement, WDaytime sleep and alertness. In: Kryger, MHRoth, RDement, WC ed. Principles and practice of sleep medicine Philadelphia: Saunders, 1989 14–23Google Scholar
Rüther, EClarenbach, PHajak, GInfluence of zopiclone on sleep quality and daytime well-being vs flunitrazepam or uiazolam or placebo in patients with iasomnia. Pharmacopsychiatry 1992; 25: 112Google Scholar
Steinert, JBotros, WKurian, TPatel, AGPriest, RGDouble-blind comparison of zopiclone and triazolam as hypnotics. In: Koella, WPRüther, ESchulz, H eds. Sleep '84 Stuttgart: Fischer, 1984 328–9Google Scholar
Tamminen, JHansen, PPChronic administration of zopiclone and nitrazepam in the treatment of insomnia. Sleep 1987; 10(suppl 1):63–72Google ScholarPubMed
Task Force on Sedative Hypnotics Report of the World Psychiatric Association May, 1992Google Scholar
Venter, CPJoubert, PHStahmer, SDVenter, MRSharkey, JZopiclone compared with triazolam in insomnia in geriatric patientsCurr. Ther Res 1986; 40: 1062–8Google Scholar
Wickström, RGodtlibsen, OBBredesen, JEJensen, MHPerformance and mood following partial sleep deprivation: a randomized, double blind crossover study of zopiclone, triazolam, flunitrazepam, ethanol and placebo. Hum Psychopharmacol 1988; 3: 3–11CrossRefGoogle Scholar
World Health Organization Tenth revision of the international classification of diseases Chapter V (F): Mental and behavioural disorders (including disorders of the psychological development) Clinical descriptions and diagnostic guidelines Genf>: World Health Organization, 1991:+World+Health+Organization,+1991>Google Scholar
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