Eszopiclone for insomnia
- PMID: 30303519
- PMCID: PMC6492503
- DOI: 10.1002/14651858.CD010703.pub2
Eszopiclone for insomnia
Abstract
Background: Insomnia is a major public health issue affecting between 6% to 10% of the adult population in Western countries. Eszopiclone is a hypnotic drug belonging to a newer group of hypnotic agents, known as new generation hypnotics, which was marketed as being just as effective as benzodiazepines for this condition, while being safer and having a lower risk for abuse and dependence. It is the aim of the review to integrate evidence from randomised controlled trials and to draw conclusions on eszopiclone's efficacy and safety profile, while taking methodological features and bias risks into consideration.
Objectives: To assess the efficacy and safety of eszopiclone for the treatment of insomnia compared to placebo or active control.
Search methods: We searched the Cochrane Central Register of Controlled trials (CENTRAL), MEDLINE, Embase, PsycINFO, PSYNDEX and registry databases (WHO trials portal, ClinicalTrials.gov) with results incorporated from searches to 10 February 2016. To identify trials not registered in electronic databases, we contacted key informants and searched reference lists of identified studies. We ran an update search (21 February 2018) and have placed studies of interest in awaiting classification/ongoing studies. These will be incorporated into the next version of the review, as appropriate.
Selection criteria: Parallel group randomised controlled trials (RCTs) comparing eszopiclone with either placebo or active control were included in the review. Participants were adults with insomnia, as diagnosed with a standardised diagnostic system, including primary insomnia and comorbid insomnia.
Data collection and analysis: Two authors independently extracted outcome data; one reviewer assessed trial quality and the second author cross-checked it.
Main results: A total of 14 RCTs, with 4732 participants, were included in this review covering short-term (≤ 4 weeks; 6 studies), medium-term (> 4 weeks ≤ 6 months; 6 studies) and long-term treatment (> 6 months; 2 studies) with eszopiclone. Most RCTs included in the review included participants aged between 18 and 64 years, three RCTs only included elderly participants (64 to 85 years) and one RCT included participants with a broader age range (35 to 85 years). Seven studies considered primary insomnia; the remaining studies considered secondary insomnia comorbid with depression (2), generalised anxiety (1), back pain (1), Parkinson's disease (1), rheumatoid arthritis (1) and menopausal transition (1).Meta-analytic integrations of participant-reported data on sleep efficacy outcomes demonstrated better results for eszopiclone compared to placebo: a 12-minute decrease of sleep onset latency (mean difference (MD) -11.94 min, 95% confidence interval (CI) -16.03 to -7.86; 9 studies, 2890 participants, moderate quality evidence), a 17-minute decrease of wake time after sleep onset (MD -17.02 min, 95% CI -24.89 to -9.15; 8 studies, 2295 participants, moderate quality evidence) and a 28-minute increase of total sleep time (MD 27.70 min, 95% CI 20.30 to 35.09; 10 studies, 2965 participants, moderate quality evidence). There were no significant changes from baseline to the first three nights after drug discontinuation for sleep onset latency (MD 17.00 min, 95% CI -4.29 to 38.29; 1 study, 291 participants, low quality evidence) and wake time after sleep onset (MD -6.71 min, 95% CI -21.25 to 7.83; 1 study, 291 participants, low quality evidence). Adverse events during treatment that were documented more frequently under eszopiclone compared to placebo included unpleasant taste (risk difference (RD) 0.18, 95% CI 0.14 to 0.21; 9 studies, 3787 participants), dry mouth (RD 0.04, 95% CI 0.02 to 0.06; 6 studies, 2802 participants), somnolence (RD 0.04, 95% CI 0.02 to 0.06; 8 studies, 3532 participants) and dizziness (RD 0.03, 95% CI 0.01 to 0.05; 7 studies, 2933 participants). According to the GRADE criteria, evidence was rated as being of moderate quality for sleep efficacy outcomes and adverse events and of low quality for rebound effects and next-day functioning.
Authors' conclusions: Eszopiclone appears to be an efficient drug with moderate effects on sleep onset and maintenance. There was no or little evidence of harm if taken as recommended. However, as certain patient subgroups were underrepresented in RCTs included in the review, findings might not have displayed the entire spectrum of possible adverse events. Further, increased caution is required in elderly individuals with cognitive and motor impairments and individuals who are at increased risk of using eszopiclone in a non-recommended way.
Conflict of interest statement
Rösner S: no conflict of interest known
Englbrecht C: no conflict of interest known
Wehrle R: no conflict of interest known
Hajak G: received speaker/consultancy/advisory board honoraria from Actelion, Astra‐Zeneca, Bristol‐Meyers Squibb, Boehringer Ingelheim, Cephalon, EuMeCom, GlaxoSmithKline, Janssen‐Cilag, Lilly, Lundbeck, Novartis, Organon, Pfizer, Sanofi‐Aventis, Servier, Takeda, Wyeth. Advisory Boards: Actelion, Astra‐Zeneca, Bristol‐Meyers Squibb, Janssen‐Cilag, Lilly, Lundbeck, Neurocrine, Organon, Pfizer, Sanofi‐Aventis, Sepracor, Servier, Takeda, Wyeth.
Industrie‐Drittmittel: Actelion, Affectis, Astra‐Zeneca, Boehringer Ingelheim, GlaxoSmithKline, Lundbeck, Novartis, Organon, Sanofi‐Aventis, Sepracor, Servier, Takeda.
Soyka M: received speaker/consultancy/advisory board honoraria from Lipha Pharmaceuticals, Forest Laboratories, Sanofi‐Aventis, Essex Pharma, Eli Lilly, Prempharm, Lundbeck, and AstraZeneca.
Figures
Update of
References
References to studies included in this review
Ancoli‐Israel 2010 {published data only}
Fava 2006 {published data only}
-
- Fava M, McCall WV, Krystal A, Wessel T, Rubens R, Caron J, et al. Eszopiclone co‐administered with fluoxetine in patients with insomnia coexisting with major depressive disorder. Biological Psychiatry 2006;59(11):1052‐60. - PubMed
Goforth 2014 {published data only}
Krystal 2003 {published data only}
-
- Krystal AD, Walsh JK, Laska E, Caron J, Amato DA, Wessel TC, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomised, double‐blind, placebo‐controlled study in adults with chronic insomnia. Sleep 2003;26(7):793‐9. - PubMed
McCall 2006 {published data only}
-
- McCall WV, Erman M, Krystal AD, Rosenberg R, Scharf M, Zammit GK, et al. A polysomnography study of eszopiclone in elderly patients with insomnia. Current Medical Research and Opinion 2006;22(9):1633‐42. - PubMed
McCall 2010a {published data only}
Menza 2010 {published data only}
Pollack 2008 {published data only}
-
- Pollack M, Kinrys G, Krystal A, McCall WV, Roth T, Schaefer K, et al. Eszopiclone co‐administered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Archives of General Psychiatry 2008;65(5):551‐62. - PubMed
Roth 2009 {published data only}
Scharf 2005 {published data only}
-
- Scharf M, Erman M, Rosenberg R, Seiden D, McCall WV, Amato D, et al. A 2‐week efficacy and safety study of eszopiclone in elderly patients with primary insomnia. Sleep 2005;28(6):720‐7. - PubMed
Soares 2006 {published data only}
-
- Soares CN, Joffe H, Rubens R, Caron J, Roth T, Cohen L. Eszopiclone in patients with insomnia during perimenopause and early postmenopause: a randomised controlled trial. Obstetrics & Gynecology 2006;108(6):1402‐10. - PubMed
Spierings 2015 {published data only}
-
- Spierings EL, McAllister PJ, Bilchik TR. Efficacy of treatment of insomnia in migraineurs with eszopiclone (Lunesta) and its effect on total sleep time, headache frequency, and daytime functioning: a randomised, double‐blind, placebo‐controlled, parallel‐group, pilot study. Cranio 2015;33(2):115‐21. - PubMed
Walsh 2007 {published data only}
Zammit 2004 {published data only}
-
- Zammit GK, McNabb LJ, Caron J, Amato DA, Roth T. Efficacy and safety of eszopiclone across 6‐weeks of treatment for primary insomnia. Current Medical Research and Opinion 2004;20(12):1979‐91. - PubMed
References to studies excluded from this review
Attarian 2011 {published data only}
Boyle 2008 {published data only}
-
- Boyle J, Trick L, Johnsen S, Roach J, Rubens R. Next‐day cognition, psychomotor function, and driving‐related skills following nighttime administration of eszopiclone. Human Psychopharmacology 2008;23(5):385‐97. - PubMed
Boyle 2012 {published data only}
-
- Boyle J, Groeger JA, Paska W, Cooper JA, Rockett C, Jones S, et al. A method to assess the dissipation of residual hypnotics: eszopiclone versus zopiclone. Journal of Clinical Psychopharmacology 2012;32(5):704‐9. - PubMed
Demanuele 2014 {published data only}
-
- Demanuele C, Bartsch U, Wamsley EJ, Shinn AK, Goff DC, Jones MW. The effects of eszopiclone on slow wave modulation of sleep spindles in schizophrenia. 69th Annual Scientific Convention and Meeting of the Society of Biological Psychiatry. New York, United States, 2014.
Dimsdale 2011b {published data only}
Eckert 2011 {published data only}
Erman 2008 {published data only}
Gross 2011 {published data only}
Huang 2015 {published data only}
-
- Huang Y, Zheng Y. Sleep disorder of schizophrenia treated with shallow needling: a randomised controlled trial. Zhongguo Zhenjiu 2015;35(9):869‐73. - PubMed
Joffe 2010 {published data only}
-
- Joffe H, Petrillo L, Viguera A, Koukopoulos A, Silver‐Heilman K, Farrell A, et al. Eszopiclone improves insomnia and depressive and anxious symptoms in perimenopausal and postmenopausal women with hot flashes: a randomised, double‐blinded, placebo‐controlled crossover trial. American Journal of Obstetrics & Gynecology 2010;202(2):171.e1‐171.e11. - PubMed
Lettieri 2008 {published data only}
NCT00120250 {unpublished data only}
-
- NCT00120250. Eszopiclone for sleep disturbance and nightmares in post‐traumatic stress disorder. clinicaltrials.gov/show/NCT000120250 (first received 15 July 2005).
NCT00368056 {unpublished data only}
-
- NCT00368056. Effects of one evening dose of 3 mg eszopiclone on next day driving ability. clinicaltrials.gov/ct2/results?term=NCT00368056 (first received 24 August 2006).
NCT00374192 {unpublished data only}
-
- NCT00374192. The treatment of insomnia in symptomatic peri‐ and postmenopausal women. clinicaltrials.gov/ct2/show/NCT00374192 (first received 11 September 2006).
NCT00460993 {unpublished data only}
-
- NCT00460993. Efficacy & safety of eszopiclone (Lunesta) in nursing home patients. clinicaltrials.gov/show/NCT000460993 (first received 17 April 2007).
NCT00511134 {unpublished data only}
-
- NCT00511134. Study of lunesta versus placebo for sleep problems related to smoking cessation and zyban. clinicaltrials.gov/ct2/show/NCT00511134 (first received 3 August 2007).
NCT00616655 {published data only}
-
- NCT00616655. Generalized anxiety disorder proof of concept efficacy and safety study of SEP‐225441 (eszopiclone) In GAD subjects. clinicaltrials.gov/show/NCT000616655 (first received 15 February 2008).
NCT00685269 {unpublished data only}
-
- NCT00685269. Safety and efficacy of eszopiclone with mild to moderate obstructive sleep apnea syndrome (OSAS). clinicaltrials.gov/show/NCT00685269 (first received 28 May 2008).
NCT00811746 {unpublished data only}
-
- NCT00811746. Hypnotics to improve polysomnography yield: eszopiclone vs ramelteon?. clinicaltrials.gov/show/NCT00811746 (first received 19 December 2008).
NCT00813735 {unpublished data only}
-
- NCT00813735. Eszopiclone co‐administered with escitalopram for insomnia in elderly adults with major depressive disorder. clinicaltrials.gov/ct2/results?term=NCT00813735 (first received 23 December 2008).
NCT00826111 {unpublished data only}
-
- NCT00826111. The effects of eszopiclone and lexapro on prefrontal glutamate and GABA in depression with anxiety and insomnia. clinicaltrials.gov/show/NCT00826111 (first received 21 January 2009).
NCT00889200 {unpublished data only}
-
- NCT00889200. Eszopiclone treatment & cortisol responsitivity. clinicaltrials.gov/show/NCT00889200 (first received 28 April 2009).
NCT00900159 {unpublished data only}
-
- NCT00900159. Effects of daytime eszopiclone administration in shift workers. clinicaltrials.gov/show/NCT00900159 (first received 12 May 2009).
NCT01102270 {unpublished data only}
-
- NCT011022270. The effect of eszopiclone on the arousal threshold in sleep apnea syndrome. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2010‐ [cited 2015 April 15]. Available from: clinicaltrials.gov/show/NCT01102270 NLM Identifier: NCT01102270 (first received 13 April 2010).
NCT01641900 {unpublished data only}
-
- NCT01641900. Effects of eszopiclone on sleep and memory in schizophrenia. clinicaltrials.gov/show/NCT01641900 (first received 17 July 2012).
NCT01710631 {unpublished data only}
-
- NCT01710631. Twelve month study of the safety of eszopiclone in adult subjects with insomnia. clinicaltrials.gov/show/NCT01710631 (first received 19 October 2012).
Peng 2013 {published data only}
-
- Peng Y. Efficacy of eszopiclone combined with psychotherapy in the treatment of insomnia. Chinese Journal of New Drugs 2013;22:443‐6.
Pollack 2011 {published data only}
-
- Pollack MH, Hoge EA, Worthington JJ, Moshier SJ, Wechsler RS, Brandes M, et al. Eszopiclone for the treatment of posttraumatic stress disorder and associated insomnia: a randomised, double‐blind, placebo‐controlled trial. Journal of Clinical Psychiatry 2011;72(7):892‐7. - PubMed
Rosenberg 2005 {published data only}
-
- Rosenberg R, Caron J, Roth T, Amato D. An assessment of the efficacy and safety of eszopiclone in the treatment of transient insomnia in healthy adults. Sleep Medicine 2005;6(1):15‐22. - PubMed
Rosenberg 2007 {published data only}
-
- Rosenberg R, Roach JM, Scharf M, Amato DA. A pilot study evaluating acute use of eszopiclone in patients with mild to moderate obstructive sleep apnea syndrome. Sleep Medicine 2007;8(5):464‐70. - PubMed
Sangal 2014 {unpublished data only}
-
- Sangal RB, Blumer JL, Lankford DA, Grinnell TA, Huang H. Eszopiclone for insomnia associated with attention‐deficit/hyperactivity disorder. Pediatrics 2014;134(4):1095‐103. - PubMed
Tek 2014 {published data only}
-
- Tek C, Palmese LB, Krystal AD, DeGeorge PC, Reutenauer EL, Guloksuz S. The impact of eszopiclone insomnia treatment on cognition in schizophrenia: a double‐blind, randomized, placebo‐controlled trial. 69th Annual Scientific Convention and Meeting of the Society of Biological Psychiatry. New York, United States, 2014.
Uchimura 2012a {published data only}
-
- Uchimura N, Kamijo A, Takase T. Effects of eszopiclone on safety, subjective measures of efficacy, and quality of life in elderly and non‐elderly Japanese patients with chronic insomnia, both with and without comorbid psychiatric disorders: a 24‐week, randomised, double‐blind study. Annals of General Psychiatry 2012;25(11):2‐15. - PMC - PubMed
Uchimura 2012b {published data only}
-
- Uchimura N, Kamijo A, Kuwahara H, Uchiyama M, Shimizu T, Chiba S, Inoue Y. A randomized placebo‐controlled polysomnographic study of eszopiclone in Japanese patients with primary insomnia. Sleep Med 2012;13(10):1247‐53. - PubMed
References to studies awaiting assessment
Baran 2017 {published data only}
-
- Baran B, Demanuele C, Vuper TC. The effects of eszopiclone on sleep spindles and memory consolidation in schizophrenia: a double‐blind randomised trial. Sleep Conference: 31st Anniversary Meeting of the Associated Professional Sleep Societies, LLC, SLEEP. United States, 2017; Vol. 40:A415.
Buxton 2017 {published data only}
NCT00374556 {published data only}
-
- NCT00374556. The efficacy of eszopiclone (Lunesta) for chronic insomnia associated with osteoarthritis. clinicaltrials.gov/ct2/show/NCT00374556 (first received 11 September 2006).
NCT00392041 {unpublished data only}
-
- NCT00392041. Eszopiclone in the treatment of insomnia and associated symptoms of fibromyalgia. clinicaltrials.gov/ct2/show/NCT00392041 (first received 25 October 2006).
NCT00435279 {unpublished data only}
-
- EUCTR2006‐001529‐24 [HU, AT, GB, FR]. Adults administered Venlafaxine and Eszopiclone Response to Treatment (AVERT): A 31‐Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co‐administered with Venlafaxine in Subjects with Major Depressive Disorder (MDD) and Co‐existing Insomnia. https://www.clinicaltrialsregister.eu/ 2006.
-
- NCT00435279. A 31‐week, efficacy, safety and tolerability study of eszopiclone 3 mg co‐administered with venlafaxine in subjects with major depressive disorder (MDD) and co‐existing insomnia. clinicaltrials.gov/ct2/show/NCT00435279 (first received 14 February 2007).
Pinto 2016 {published data only}
-
- NCT01100164. A Non‐inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg ‐ for the Treatment of Insomnia (Eszo). https://clinicaltrials.gov/ct2/show/NCT01100164 2010.
References to ongoing studies
Emiko 2015 {unpublished data only}
-
- Emiko H, Tsuyoshi M. Efficacy and safety of eszopiclone in the treatment of insomnia complicated with nocturnal awakenings associated with urination. upload.umin.ac.jp/cgi‐open‐bin/ctr/ctr.cgi?function=brows&action=bro... (accessed 16‐Feb‐2016).
NCT02456532 {unpublished data only}
-
- NCT02456532. Safety and efficacy of chronic hypnotic use 2 (CIS2). clinicaltrials.gov/ct2/show/NCT02456532 (first received 28 May 2015).
Additional references
American Academy of Sleep Medicine 2014
-
- American Academy of Sleep Medicine. International Classification of Sleep Disorders: Diagnostic and Coding Manual, ICSD‐3. 3nd. Chicago: American Academy of Sleep Medicine, 2014.
American Psychiatric Association 2013
-
- American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, DSM‐5. 5th Edition. Washington DC: American Psychiatric Publishing, 2013.
Angst 1989
-
- Angst J, Vollrath M, Koch R, Dobler‐Mikola A. The Zurich Study. VII. Insomnia: symptoms, classification and prevalence. European Archives of Psychiatry and Neurological Sciences 1989;238(5‐6):285‐93. - PubMed
Arnedt 2007
Ballenger 2000
-
- Ballenger JC. Benzodiazepine receptor agonists and antagonists. In: Sadock VA, Sadock BJ, Kaplan HI editor(s). Kaplan & Sadock's Comprehensive Textbook of Psychiatry. 7th Edition. Philadelphia: Lippincott Williams & Wilkins, 2000.
Barbone 1998
-
- Barbone F, McMahon AD, Davey PG, Morris AD. Association of road‐traffic accidents with benzodiazepine use. Lancet 1998;352(9137):1331‐6. - PubMed
Bastien 2001
-
- Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine 2001;2:297‐307. - PubMed
Bastien 2004
-
- Bastien CH, Vallières A, Morin CM. Precipitating factors of insomnia. Behavioral Sleep Medicine 2004;2(1):50‐62. - PubMed
Bateson 2004
-
- Bateson AN. The benzodiazepine site of the GABAA receptor: an old target with new potential?. Sleep Medicine 2004;5(1):9‐15. - PubMed
Ben‐Hamou 2011
-
- Ben‐Hamou M, Marshall NS, Grunstein RR, Saini B, Fois RA. Spontaneous adverse event reports associated with zolpidem in Australia 2001‐2008. Journal of Sleep Research 2011;20(4):559‐68. - PubMed
Berry 2013
Bertisch 2014
Bolton 2008
-
- Bolton JM, Metge C, Lix L, Prior H, Sareen J, Leslie WD. Fracture risk from psychotropic medications: a population‐based analysis. Journal of Clinical Psychopharmacology 2008;28(4):384‐91. - PubMed
Botteman 2007
-
- Botteman MF, Ozminkowski RJ, Wang S, Pashos CL, Schaefer K, Foley DJ. Cost effectiveness of long‐term treatment with eszopiclone for primary insomnia in adults: a decision analytical model. CNS Drugs 2007;21(4):319‐34. - PubMed
Brower 2001
Brunello 2008
-
- Brunello N, Bettica P, Amato D, Maier G, Nutt D. Pharmacokinetics of (S)‐zopiclone and (S)‐desmethylzopiclone following dosing with zopiclone and eszopiclone. Neuropsychopharmacology 2008;18:581.
Brunette 2003
-
- Brunette MF, Noordsy DL, Xie H, Drake RE. Benzodiazepine use and abuse among patients with severe mental illness and co‐occurring substance use disorders. Psychiatric Services 2003;54(10):1395‐401. - PubMed
Buscemi 2007
Buysse 2011
Cape 2015
-
- Cape J, Leibowitz J, Whittington C, Espie CA, Pilling S. Group cognitive behavioural treatment for insomnia in primary care: a randomised controlled trial. Psychological Medicine 2015;16:1‐11. - PubMed
Cappuccio 2011
-
- Cappuccio FP, Cooper D, D'Elia L, Strazzullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta‐analysis of prospective studies. European Heart Journal 2011;32(12):1484‐92. - PubMed
Cimolai 2007
Conroy 2006
Deeks 2011
-
- Deeks J, Higgins JPT, Altman DG. Chapter 9: Analysing data and undertaking meta‐analyses. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Delahaye 1990
-
- Delahaye C, Ferrand B, Pieddeloup C, Musch B. Post marketing surveillance of zopiclone: interim analysis on the first 10,000 cases in a clinical study in general practice. International Clinical Psychopharmacology 1990;5 Suppl(2):131‐8. - PubMed
DerSimonian 1986
-
- DerSimonian R, Laird NM. Meta‐analysis in clinical trials. Controlled Clinical Trials 1986;7:177‐88. - PubMed
Diem 2014
Dolder 2007
-
- Dolder C, Nelson M, McKinsey J. Use of non‐benzodiazepine hypnotics in the elderly: are all agents the same?. CNS Drugs 2007;21(5):389‐405. - PubMed
Drover 2000
-
- Drover D, Lemmens H, Naidu S, Cevallos W, Darwish M, Stanski D. Pharmacokinetics, pharmacodynamics, and relative pharmacokinetic/pharmacodynamic profiles of zaleplon and zolpidem. Clinical Therapeutics 2000;22(12):1443‐61. - PubMed
Drover 2004
-
- Drover DR. Comparative pharmacokinetics and pharmacodynamics of short‐acting hypnosedatives: zaleplon, zolpidem and zopiclone. Clinical Pharmacokinetics 2004;43(4):227‐38. - PubMed
Duggal 2007
Dündar 2004a
-
- Dündar Y, Dodd S, Strobl J, Boland A, Dickson R, Walley T. Comparative efficacy of newer hypnotic drugs for the short‐term management of insomnia: a systematic review and meta‐analysis. Human Psychopharmacology 2004;19(5):305‐22. - PubMed
Dündar 2004b
-
- Dündar Y, Boland A, Strobl J, Dodd S, Haycox A, Bagust A, et al. Newer hypnotic drugs for the short‐term management of insomnia: a systematic review and economic evaluation. Health Technology Assessment 2004;8(24):iii‐x, 1‐125. - PubMed
Edinger 2004
-
- Edinger JD, Bonnet MH, Bootzin RR, Doghramji K, Dorsey CM, Espie CA, et al. American Academy of Sleep Medicine Work Group. Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group. Sleep 2004;27(8):1567‐96. - PubMed
Egger 1997
Eisen 1994
-
- Eisen SV, Dill DL, Grob MC. Reliability and validity of a brief patient‐report instrument for psychiatric outcome evaluation. Hospital & Community Psychiatry 1994;45(3):242‐7. - PubMed
Elko 1998
-
- Elko CJ, Burgess JL, Robertson WO. Zolpidem‐associated hallucinations and serotonin reuptake inhibition: a possible interaction.. Journal of Toxicology: Clinical Toxicology 1998;36:195–203. - PubMed
Erman 2004
-
- Erman M, Rosenberg R, Caron Y. Polysomnographic and patient‐reported evaluation of the efficacy and safety of eszopiclone in elderly subjects with chronic insomnia. Sleep 2004;27 Suppl:257‐8.
Erman 2005
-
- Erman MK. Therapeutic options in the treatment of insomnia. Journal of Clinical Psychiatry 2005;66(9):18‐23. - PubMed
Espie 2002
-
- Espie CA. Insomnia: conceptual issues in the development, persistence, and treatment of sleep disorder in adults. Annual Review of Psychology 2002;53:215‐43. - PubMed
Espie 2006
-
- Espie CA, Broomfield NM, MacMahon KM, Macphee LM, Taylor LM. The attention‐intention‐effort pathway in the development of psychophysiologic insomnia: a theoretical review. Sleep Medicine Reviews 2006;10(4):215‐45. - PubMed
European Medicines Agency 2009
-
- European Medicines Agency. Sepracor Pharmaceuticals Ltd withdraws its marketing authorisation application for Lunivia (eszopiclone). www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2009/11/... (accessed 16 February 2015).
Falcón 2009
Fava 2011
-
- Fava M, Schaefer K, Huang H, Wilson A, Iosifescu DV, Mischoulon D, et a. A post hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. Journal of Clinical Psychiatry 2011;72(4):473‐9. - PubMed
Fernández‐Mendoza 2010
-
- Fernández‐Mendoza J, Vela‐Bueno A, Vgontzas AN, Ramos‐Platón MJ, Olavarrieta‐Bernardino S, Bixler EO, et al. Cognitive‐emotional hyperarousal as a premorbid characteristic of individuals vulnerable to insomnia. Psychosomatic Medicine 2010;72(4):370‐403. - PubMed
Ferrie 2007
Finkle 2011
-
- Finkle WD, Der JS, Greenland S, Adams JL, Ridgeway G, Blaschke T, et al. Risk of fractures requiring hospitalisation after an initial prescription for zolpidem, alprazolam, lorazepam, or diazepam in older adults. Journal of the American Geriatrics Society 2011;59(10):1883‐90. - PubMed
Follesa 2002
-
- Follesa P, Mancuso L, Biggio F, Cagetti E, Franco M, Trapani G, et al. Changes in GABA(A) receptor gene expression induced by withdrawal of, but not by long‐term exposure to, zaleplon or zolpidem. Neuropharmacology 2002;42(2):191‐8. - PubMed
Food and Drug Administration 2015
-
- Food, Drug Administration. Eszopiclone containing sleep aids: drug safety communication ‐ can cause next‐day impairment. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedica... (accessed 12 March 2015).
Fortier‐Brochu 2012
-
- Fortier‐Brochu E, Beaulieu‐Bonneau S, Ivers H, Morin CM. Insomnia and daytime cognitive performance: a meta‐analysis. Sleep Medicine Reviews 2012;16(1):83‐94. - PubMed
Foster 1999
-
- Foster JH, Peters TJ. Impaired sleep in alcohol misusers and dependent alcoholics and the impact upon outcome. Alcoholism: Clinical and Experimental Research 1999;23(6):1044–51. - PubMed
Friedmann 2003
Gillin 1989
-
- Gillin JC, Spinweber CL, Johnson LC. Rebound insomnia: a critical review. Journal of Clinical Psychopharmacology 1989;9(3):161‐72. - PubMed
Greenblatt 1981
Greenblatt 2012
-
- Greenblatt DJ, Zammit GK. Pharmacokinetic evaluation of eszopiclone: clinical and therapeutic implications. Expert Opinion in Drug Metabolism and Toxicology 2012;8(12):1609‐18. - PubMed
Gunja 2013
Hair 2008
-
- Hair PI, McCormack PL, Curran MP. Eszopiclone: a review of its use in the treatment of insomnia. Drugs 2008;68(10):1415‐34. - PubMed
Hajak 1997
-
- Hajak G, Muller‐Popkes K, Riemann D, Mayer G, Lauer C. Psychological, psychotherapeutic and other non‐pharmacologic forms of therapy in treatment of insomnia. Fortschritte der Neurologie‐Psychiatrie 1997;65(3):133‐44. - PubMed
Hajak 2002a
-
- Hajak G, Bandelow B, Zulley J, Pittrow D. "As needed" pharmacotherapy combined with stimulus control treatment in chronic insomnia‐‐assessment of a novel intervention strategy in a primary care setting. Ann Clin Psychiatry 2002;14(1):1‐7. - PubMed
Hajak 2002b
-
- Hajak, G. Zolpidem "as needed" versus continuous administration: Pan‐European study results. Sleep Med Rev 2002;6(Suppl 1):21‐8. - PubMed
Hajak 2003
-
- Hajak G, Müller WE, Wittchen HU, Pittrow D, Kirch W. Abuse and dependence potential for the non‐benzodiazepine hypnotics zolpidem and zopiclone: a review of case reports and epidemiological data. Addiction 2003;98(10):1371‐8. - PubMed
Hamilton 1959
-
- Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol 1959;32(1):50‐5. - PubMed
Hamilton 1960
Harvey 2018
-
- Harvey CJ, Gehrman P, Espie CA. Who is predisposed to insomnia: a review of familial aggregation, stress‐reactivity, personality and coping style. Sleep Med Rev 2014;18(3):237‐47. - PubMed
Hausken 2009
-
- Hausken AM, Furu K, Skurtveit S, Engeland A, Bramness JG. Starting insomnia treatment: the use of benzodiazepines versus z‐hypnotics. A prescription database study of predictors. European Journal of Clinical Pharmacology 2009;65(3):295‐301. - PubMed
Higgins 2003
Higgins 2011
-
- Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org. Chichester (UK), 2011:243‐96.
Hoffmann 2009
-
- Hoffmann F, Scharffetter W, Glaeske G. Use of zolpidem and zopiclone on private prescriptions between 1993 and 2007. Der Nervenarzt 2009;80(5):578‐83. - PubMed
Hoffmann 2014
-
- Hoffmann F, Glaeske G. Benzodiazepine hypnotics, zolpidem and zopiclone on private prescriptions: use between 1993 and 2012. Der Nervenarzt 2014;85(11):1402‐9. - PubMed
Hozo 2005
Huedo‐Medina 2012
Huwiler‐Muntener 2002
-
- Huwiler‐Muntener K, Juni P, Junker C, Egger M. Quality of reporting of randomised trials as a measure of methodologic quality. Journal of the American Medical Association 2002;287(21):2801‐4. - PubMed
Jaffe 2004
-
- Jaffe JH1, Bloor R, Crome I, Carr M, Alam F, Simmons A, et al. A post‐marketing study of relative abuse liability of hypnotic sedative drugs. Addiction 2004;99(2):165‐73. - PubMed
Jenkinson 1997
-
- Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ‐39): development and validation of a Parkinson's disease summary index score. Age and Ageing 1997;26(5):353‐7. - PubMed
Johnson 2001
-
- Johnson EO, Breslau N. Sleep problems and substance use in adolescence.. Drug and Alcohol Dependence 2001;64(1):1‐7. - PubMed
Joya 2009
Kaplan 2014
-
- Kaplan KA, McQuaid J, Primich C, Rosenlicht N. An evidence‐based review of insomnia treatment in early recovery. Journal of Addiction Medicine 2014;8(6):389‐94. - PubMed
Katz 1998
-
- Katz DA, McHorney CA. Clinical correlates of insomnia in patients with chronic illness. Archives of Internal Medicine 1998;158(10):1099–1107. - PubMed
Krishnan 2011
Krystal 2007
-
- Krystal A, Fava M, Rubens R, Wessel T, Caron J, Wilson P, et al. Evaluation of eszopiclone discontinuation after co‐therapy with fluoxetine for insomnia with coexisting depression. Journal of Clinical Sleep Medicine 2007;3(1):48‐55. - PubMed
Krystal 2012a
-
- Krystal AD, Huang H, Zummo J, Grinnell T, Marshall RD. A WASO sub‐group analysis of a 6‐month study of eszopiclone 3 mg. Sleep Medicine 2012;13(6):691‐6. - PubMed
Krystal 2012b
-
- Krystal AD, McCall WV, Fava M, Joffe H, Soares CN, Huang H, et al. Eszopiclone treatment for insomnia: effect size comparisons in patients with primary insomnia and insomnia with medical and psychiatric comorbidity. The Primary Care Companion for CNS Disorders 2012;14(4):doi: 10.4088/PCC.11m01296. [DOI: 10.4088/PCC.11m01296] - DOI - PMC - PubMed
Lader 1999
-
- Lader MH. Limitations on the use of benzodiazepines in anxiety and insomnia: are they justified?. European Neuropsychopharmacology 1999;9(Suppl 6):399‐405. - PubMed
Leger 2001
-
- Leger D, Scheurmaier K, Philip P, Paillard M, Guilleminault C. SF‐36: evaluation of quality of life in severe and mild insomniac compared with good sleepers. Psychosomatic Medicine 2001;63(1):49‐55. - PubMed
Lerner 2001
-
- Lerner D, Amick BC 3rd, Rogers WH, Malspeis S, Bungay K, Cynn D. The Work Limitations Questionnaire. Medical Care 2001;39(1):72‐85. - PubMed
Leshner 2005
-
- Leshner A. NIH State‐of‐the‐Science Conference Statement on manifestations and management of chronic insomnia in adults. NIH Consensus and State‐of‐the‐Science Statements. 2005; Vol. 22:1‐30. - PubMed
Lexchin 2003
Li 2014
Licata 2008
Light 1984
-
- Light RJ, Pillemer BD. The Science of Reviewing Research. Cambridge (MA): Harvard University Press, 1984.
Lingford‐Hughes 2002
-
- Lingford‐Hughes A, Hume SP, Feeney A, Hirani E, Osman S, Cunningham VJ, et al. Imaging the GABA‐benzodiazepine receptor subtype containing the alpha 5‐subunit in vivo with (11C)Ro15 4513 positron emission tomography. Journal of Cerebral Blood Flow and Metabolism 2002;22:878–88. - PubMed
Lunesta 2004 [pers comm]
-
- Lunesta® (eszopiclone) package insert. Sepracor Inc (Sunovion Pharmaceuticals): Marlborough (MA) 2004.
Maier 1985
-
- Maier W, Philipp M. Improving the assessment of severity of depressive states: a reduction of the Hamilton Depression Scale. Pharmacopsychiatry 1985;18:114‐5.
Mantel 1959
-
- Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective disease. Journal of the National Cancer Institute 1959;22:719–48. - PubMed
Marshall 2011a
-
- Marshall RD, Grinnell T, Zummo J, Schweizer E. Treatment of primary insomnia in the elderly: predictors of response to eszopiclone. 25th Anniversary Meeting of the Associated Professional Sleep Societies, LLC, SLEEP; 2011; Minneapolis, United States. 2011.
Marshall 2011b
-
- Marshall RD, Grinnell T, Zummo J, Schweizer E. Treatment with eszopiclone in adults with primary insomnia: predictors of response. 25th Anniversary Meeting of the Associated Professional Sleep Societies; 2011; Minneapolis, United States. 2011.
McCall 2009
-
- McCall WV, D’Agostino RB, Kimball JN, Boggs N, Lasater B, Dunn A, et al. Eszopiclone at bedtime improves the quality of life in depressed insomniacs receiving fluoxetine. Sleep 2009;32:A348‐A349.
McCall 2010b
McCall 2011a
McCall 2011b
-
- McCall WV, Blocker J, Dagostino JR, Wang J, Shannon W. Both actigraphy data and the intensity of insomnia complaints differ between suicidal and non‐suicidal depressed patients enrolled in a hypnotic clinical trial. Journal of Sleep Research 2011;20(Suppl s1):24.
McCall 2012
Melton 2005
-
- Melton ST, Wood JM, Kirkwood CK. Eszopiclone for insomnia. Annals of Pharmacotherapy 2005;39(10):1659‐66. - PubMed
Metlaine 2005
-
- Metlaine A, Leger D, Choudat D. Socioeconomic impact of insomnia in working populations. Industrial Health 2005;43(1):11‐9. - PubMed
Moher 2009
Moloney 2011
Moncrieff 2004
Monti 2007
Montplaisir 2003
-
- Montplaisir J, Hawa R, Moller H, Morin C, Fortin M, Matte J, et al. Zopiclone and zaleplon vs benzodiazepines in the treatment of insomnia: Canadian consensus statement. Human Psychopharmacology 2003;18(1):29‐38. - PubMed
Morin 2006
-
- Morin CM, LeBlanc M, Daley M, Grégoire JP, Mérette C. Epidemiology of insomnia: prevalence, self‐help treatments, consultations, and determinants of help‐seeking behaviours. Sleep Medicine 2006;7:123‐30. - PubMed
Morin 2012
-
- Morin CM, Benca R. Chronic insomnia. Lancet 2012;24(379):1129‐41. - PubMed
Najib 2006
-
- Najib J. Eszopiclone, a nonbenzodiazepine sedative‐hypnotic agent for the treatment of transient and chronic insomnia. Clinical Therapeutics 2006;28(4):491‐516. - PubMed
NHS Prescribing Service 2010
-
- National Prescribing Service. Addressing hypnotic medicines use in primary care. www.nps.org.au/health_professionals/publications/nps_news/current/nps_ne... 2010.
Nickerson 1998
-
- Nickerson RS. Confirmation bias: a ubiquitous phenomenon in many guises. Review of General Psychology 1998;2(2):175–220.
Nutt 2010
-
- Nutt DJ, Stahl SM. Searching for perfect sleep: the continuing evolution of GABAA receptor modulators as hypnotics. Journal of Psychopharmacology 2010;24(11):1601‐12. - PubMed
Ohayon 2002
-
- Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Medicine Reviews 2002;6(2):97‐111. - PubMed
Ohayon 2009
Palagini 2014
-
- Palagini L, Biber K, Riemann D. The genetics of insomnia‐‐evidence for epigenetic mechanisms?. Sleep Med Rev 2014;18(3):225‐35. - PubMed
Parthasaraty 2015
Perlis 1997
-
- Perlis ML, Giles DE, Mendelson WB, Bootzin RR, Wyatt JK. Psychophysiological insomnia: the behavioural model and a neurocognitive perspective. Journal of Sleep Research 1997;6:179‐88. - PubMed
Pildal 2007
-
- Pildal J, Hrobjartsson A, Jorgensen KJ, Hilden J, Altman DG, Gotzsche PC. Impact of allocation concealment on conclusions drawn from meta‐analyses of randomized trials. International Journal of Epidemiology 2007;36(4):847‐57. - PubMed
Ramakrishnan 2007
-
- Ramakrishnan K, Scheid DC. Treatment options for insomnia. American Family Physician 2007;76(4):517‐26. - PubMed
Review Manager 2014 [Computer program]
-
- Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager 5 (RevMan 5). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Riemann 2007
-
- Riemann D. Insomnia and comorbid psychiatric disorders. Sleep Medicine 2007;8(4):15‐20. - PubMed
Riemann 2009
-
- Riemann D, Kloepfer C, Berger M. Functional and structural brain alterations in insomnia: implications for pathophysiology. European Journal of Neuroscience 2009;29(9):1754‐60. - PubMed
Riemann 2014
-
- Riemann D, Baglioni C, Feige B, Spiegelhalder K. Insomnia ‐ state of the science. Der Nervenarzt 2014;85(1):43‐9. - PubMed
Riemann 2015
-
- Riemann D, Nissen C, Palagini L, Otte A, Perlis ML, Spiegelhalder K. The neurobiology, investigation, and treatment of chronic insomnia. Lancet Neurolology 2015;14(5):547‐58. - PubMed
Roane 2008
Roland 1983
-
- Roland MO, Morris RW. A study of the natural history of back pain. Development of a reliable and sensitive measure of disability in low back pain. Spine 1983;8:141‐4. - PubMed
Rosekind 2010
-
- Rosekind MR, Gregory KB. Insomnia risks and costs: health, safety, and quality of life. American Journal of Managed Care 2010;16(8):617‐26. - PubMed
Roth 2003
-
- Roth T, Roehrs T. Insomnia: epidemiology, characteristics, and consequences. Clinical Cornerstone 2003;5(3):5‐15. - PubMed
Roth 2005
-
- Roth T, Walsh JK, Krystal A, Wessel T, Roehrs TA. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Medicine 2005;6(6):487‐95. - PubMed
Roth 2009a
-
- Roth T. Sleep duration, insomnia and longevity. Sleep Medicine 2009;10(10):1071‐2. - PubMed
Royal College of Psychiatrists 1997
-
- Royal College of Psychiatrists. Benzodiazepines: risks, benefits or dependence. A re‐evaluation. Council Report CR59; 1997; London 1997.
Rudolph 2011
Rösner 2013a
Rösner 2013b
Rösner 2013c
Rücker 2008
Sateia 2017
Scharf 2006
-
- Scharf M. Eszopiclone for the treatment of insomnia. Expert Opinion in Pharmacotherapy 2006;7(3):345‐56. - PubMed
Schnitzer 2005
-
- Schnitzer T, Rubens R, Price. The effect of eszopiclone 3 mg compared with placebo in patients with rheumatoid arthritis and co‐existing insomnia. American College of Rheumatology Conference; 2005 November 12–17; 2005; San Diego (poster). 2005.
Schulz 1995
-
- Schulz KF. Subverting randomization in controlled trials. Journal of the American Medical Association 1995;274(18):1456‐8. - PubMed
Schulz 2010
Schutte‐Rodin 2008
Sepracor 2004 [pers comm]
-
- Prescribing information. Lunesta® (eszopiclone). Sepracor Inc; Marlborough MA.
Shekleton 2010
-
- Shekleton JA, Rogers NL, Rajaratnam SM. Searching for the daytime impairments of primary insomnia. Sleep Medicine Reviews 2010;14(1):47‐60. - PubMed
Sieghart 2006
-
- Sieghart W. Structure, pharmacology, and function of GABAA receptor subtypes. Advances in Pharmacology 2006;54:231‐63. - PubMed
Siriwardena 2008
Snedecor 2009
Sofi 2014
-
- Sofi F, Cesari F, Casini A, Macchi C, Abbate R, Gensini G. Insomnia and risk of cardiovascular disease: a meta‐analysis. European Journal of Preventive Cardiology 2014;21(1):57‐64. - PubMed
Soyka 2000
-
- Soyka M, Bottlender R, Möller HJ. Epidemiological evidence for a low abuse potential of zolpidem. Pharmacopsychiatry 2000;33(4):138‐41. - PubMed
Spielman 1991
-
- Spielman AJ, Glovinsky PB. The varied nature of insomnia. In: Hauri P editor(s). Case Studies in Insomnia. New York: Plenum Press, 1991:1‐15.
Strebbing 2005
-
- Stebbing J, Waters L, Davies L, Mandalia S, Nelson M, Gazzard B, et al. Incidence of cancer in individuals receiving chronic zopiclone or eszopiclone requires prospective study. Journal of Clinical Oncology 2005;23(31):8134‐6. - PubMed
Toner 2000
-
- Toner LC, Tsambiras BM, Catalano G. Central nervous system side effects associated with zolpidem treatment. Clinical Neuropharmacology 2000;23:54‐8. - PubMed
Tsai 2003
-
- Tsai MJ, Huang YB, Wu PC. A novel clinical pattern of visual hallucination after zolpidem use. Journal of Toxicology: Clinical Toxicology 2003;41:869–72. - PubMed
Tyrer 1990
-
- Tyrer P, Murphy S, Riley P. The Benzodiazepine Withdrawal Symptom Questionnaire. Journal of Affective Disorders 1990;19:53‐61. - PubMed
Valieres 2005
-
- Vallières A, Ivers H, Bastien CH, Beaulieu‐Bonneau S, Morin CM. Variability and predictability in sleep patterns of chronic insomniacs. Journal of Sleep Research 2005;14(4):447‐53. - PubMed
van Straten 2018
-
- Straten A, Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta‐analysis. Sleep Med Rev 2018;38:3‐16. - PubMed
Victorri‐Vigneau 2014
-
- Victorri‐Vigneau C, Gérardin M, Rousselet M, Guerlais M, Grall‐Bronnec M, Jolliet P. An update on zolpidem abuse and dependence. Journal of Addictive Diseases 2014;33(1):15‐22. - PubMed
Vorderholzer 2001
-
- Voderholzer U, Riemann D, Hornyak M, Backhaus J, Feige B, Berger M, et al. A double‐blind, randomised and placebo‐controlled study on the polysomnographic withdrawal effects of zopiclone, zolpidem and triazolam in healthy subjects. European Archives of Psychiatry and Clinical Neuroscience 2001;251(3):117‐23. - PubMed
Wang 2001
-
- Wang PS, Bohn RL, Glynn RJ, Mogun H, Avorn J. Zolpidem use and hip fractures in older people. Journal of the American Geriatrics Society 2001;49.(12):1685‐90. - PubMed
Ware 1992
-
- Ware JE Jr, Sherbourne CD. The MOS 36‐item short‐form health survey (SF‐36). I. Conceptual framework and item selection. Med Care 1992;30(6):473‐83. - PubMed
Wechsler 1955
-
- Wechsler D. Manual for the Wechsler scale. New York, NY: Psychological Corporation, 1955.
Wilson 2010
-
- Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, et al. British Association for Psychopharmacology consensus statement on evidence‐based treatment of insomnia, parasomnias and circadian rhythm disorder. Journal of Psychopharmacology 2010;24(11):1577‐601. - PubMed
Winkelman 2015
-
- Winkelman JW. Insomnia [Insomnia Disorder]. N Engl J Med 2015;373(15):1437‐44. - PubMed
Woolcott 2009
-
- Woolcott JC, Richardson KJ, Wiens MO, Patel B, Marin J, Khan KM, et al. Meta‐analysis of the impact of 9 medication classes on falls in elderly persons. Archives of Internal Medicine 2009;169(21):1952‐60. - PubMed
World Health Organization 1992
-
- World Health Organization. The ICD‐10 Classification of Mental and Behavioural Disorders. Geneva: The World Health Organization, 1992.
Xiao 2014
Zammit 1999
-
- Zammit GK, Weiner J, Damato N, Sillup GP, McMillan CA. Quality of life in people with insomnia. Sleep 1999;22(2):379‐85. - PubMed
Zammit 2009
-
- Zammit G. Comparative tolerability of newer agents for insomnia. Drug Safety 2009;32(9):735‐48. - PubMed
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical
Miscellaneous
