A polysomnographic placebo-controlled evaluation of the efficacy and safety of eszopiclone relative to placebo and zolpidem in the treatment of primary insomnia

Journal of Clinical Sleep Medicine

Volumn 4, Issue 3, 2008, Pages 229-234

  Erman, Milton K ^a   Zammit, Gary ^b   Rubens, Robert ^c   Schaefer, Kendyl ^c   Wessel, Thomas ^c   Amato, David ^c   Caron, Judy ^c   Walsh, James K ^d,e  

^a Pacific Sleep Medicine Services Inc   (United States)

^b Department of Neurology and the Taub Institute for Research on Alzheimer's Disease and the Aging Brain   (United States)

^c SUNOVION PHARMACEUTICALS INC   (United States)

^d SAINT LOUIS UNIVERSITY   (United States)

^e Sleep Medicine and Research Center   (United States)

Author keywords

Eszopiclone; Insomnia; Polysomnography; Sleep maintenance; Zolpidem

Indexed keywords

ESZOPICLONE; PLACEBO; ZOLPIDEM;

ADULT; AROUSAL; ARTICLE; BEDTIME DOSAGE; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIZZINESS; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EVALUATION; FEMALE; HALLUCINATION; HEADACHE; HUMAN; INSOMNIA; LATENCY TO PERSISTENT SLEEP; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PARAMETER; POLYSOMNOGRAPHY; RANDOMIZED CONTROLLED TRIAL; SLEEP; SLEEP EFFICIENCY; SOMNOLENCE; TASTE DISORDER; TREATMENT OUTCOME; WAKE TIME AFTER SLEEP ONSET; WAKE TIME DURING SLEEP; WAKEFULNESS;

EID: 47849130234     PISSN: 15509389     EISSN: 15509397     Source Type: Journal    
DOI: 10.5664/jcsm.27185     Document Type: Article

References (22)

1. Roth T, Ancoli-Israel S. Daytime consequences and correlates of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. II. Sleep 1999;22:S354-8.
2. Hatoum HT, Kon SD, Kania CM, Wong JM, Mendelson WB. Insomnia, health-related quality of life and healthcare resource consumption: a study of managed-care organization enrollees. Pharmacoeconomics 1998;14: 629-37.
3. Simon GE, VonKorff M. Prevalence, burden, and treatment of insomnia in primary care. Am J Psychiatry 1997;154;1417-23.
4. Ozminkowski RJ, Wang S, Walsh JK. The direct and indirect costs of untreated insomnia in adults in the United States. Sleep 2007;30;260-70.
5. Godet-Cayre V, Pelletier-Fleury N, Le VM, Dinet J, Massuel MA, Leger D. Insomnia and absenteeism at work. Who pays the cost? Sleep 2006;29:179-84.
6. Walsh JK. Clinical and socioeconomic correlates of insomnia. J Clin Psychiatry 2004;65:13-9.
7. Ancoli-Israel S, Roth T. Characteristics of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. I. Sleep 1999;22:S347-53.
8. Leger D, Poursain B. An international survey of insomnia: underrecognition and under-trearment of a polysymptomatic condition. Curr Med Res Opin 2005;21:1785-1792.
9. Bitwise DL, King AC, Harris RB, Haskell WL. Prevalence of self-reported poor sleep in a healthy population aged 50-65. Soc Sci Med 1992;34:49-55.
10. Shochat T, Umphress J, Israel AG, Ancoli-Israel S. Insomnia in primary care patients. Sleep 1999;22:S359-65.
11. Hohagen F, Kappler C, Schramm E, Riemann D, Weyerer S, Berger M. Sleep onset insomnia, sleep maintaining insomnia and insomnia with early morning awakening-temporal stability of subtypes in a longitudinal study on general practice attenders. Sleep 1994;17:551-4.
12. Krystal AD, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep 2003;26:793-9.
13. Walsh J, Krystal AD, Amato DA, et al. Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations. Sleep 2007;30:959-68.
14. Rechtschaffen A, Kales A. Amanual of standardized terminology, techniques and scoring system for sleep states of human subjects. NIH 1968; Publication No. 204.
15. 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 Med 2005;6:15-22.
16. Zammit G, McNabb L, Caron J, Amato D, Roth T. Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia. Curr Med Res Opin 2004;20:1979-91.
17. Scharf MB, Roth T, Vogel GW, Walsh JK. A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry 1994;55:192-9.
18. Ware JC, Walsh JK, Scharf MB, Roehrs T, Roth T, Vogel GW. Minimal rebound insomnia after treatment with 10-mg zolpidem. Clin Neuropharmacol 1997;20:116-25.
19. Fava M, McCall WV, Krystal A, et al. Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder. Biol Psychiatry 2006;59:1052-60.
20. Soares CN, Joffe H, Rubens R, Caron J, Roth T, Cohen L. Eszopiclone in patients with insomnia during perimenopause and early postmenopause. Obstet Gynecol 2006;108:1402-10.
21. Pollack M, Kinrys G, Krystal A, et al. Eszopiclone co-administered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry 2008;65:551-62.
22. Smith AJ, Alder L, Silk J, et al. Effect of α subunit on allosteric modulation of ion channel function in stably expressed human recombinant λ-aminobutyric acid(A) receptors determined using (36)Cl ion flux. Mol Pharm 2001;59:1108-18.