Ramelteon for the treatment of insomnia in adults: A systematic review and meta-analysis

Sleep Medicine

Volumn 15, Issue 4, 2014, Pages 385-392

  Kuriyama, Akira ^a   Honda, Michitaka ^b   Hayashino, Yasuaki ^c  

^a KURASHIKI CENTRAL HOSPITAL   (Japan)

^b CANCER INSTITUTE HOSPITAL   (Japan)

^c TENRI HOSPITAL   (Japan)

Author keywords

Insomnia; Melatonin receptor agonist; Meta analysis; Primary insomnia; Ramelteon; Systematic review

Indexed keywords

PLACEBO; RAMELTEON; INDENE DERIVATIVE; MELATONIN RECEPTOR;

ABDOMINAL PAIN; ADULT; DIARRHEA; DISEASE DURATION; DIZZINESS; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DYSMENORRHEA; DYSPEPSIA; FATIGUE; HEADACHE; HUMAN; INSOMNIA; META ANALYSIS; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REM SLEEP; REVIEW; RHINOPHARYNGITIS; SLEEP AROUSAL DISORDER; SLEEP QUALITY; SLEEP TIME; SOMNOLENCE; SYSTEMATIC REVIEW; UPPER RESPIRATORY TRACT INFECTION; WAKEFULNESS; ADOLESCENT; AGED; AGONISTS; DRUG EFFECTS; FEMALE; MALE; MIDDLE AGED; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; FEMALE; HUMANS; INDENES; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTORS, MELATONIN; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84897473158     PISSN: 13899457     EISSN: 18785506     Source Type: Journal    
DOI: 10.1016/j.sleep.2013.11.788     Document Type: Review

References (47)

1. Ohayon M.M. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev 2002, 6:97-111.
2. Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med 2007, 3:S7-S10.
3. Brower K.J. Insomnia, alcoholism and relapse. Sleep Med Rev 2003, 7:523-539.
4. Winokur A., Gary K.A., Rodner S., Rae-Red C., Fernando A.T., Szuba M.P. Depression, sleep physiology, and antidepressant drugs. Depress Anxiety 2001, 14:19-28.
5. Katz D.A., McHorney C.A. Clinical correlates of insomnia in patients with chronic illness. Arch Intern Med 1998, 158:1099-1107.
6. Baglioni C., Battagliese G., Feige B., Spiegelhalder K., Nissen C., Voderholzer U., et al. Insomnia as a predictor of depression: a meta-analytic evaluation of longitudinal epidemiological studies. J Affect Disord 2011, 135:10-19.
7. Troxel W.M., Buysse D.J., Matthews K.A., Kip K.E., Strollo P.J., Hall M., et al. Sleep symptoms predict the development of the metabolic syndrome. Sleep 2010, 33:1633-1640.
8. Laugsand L.E., Vatten L.J., Platou C., Janszky I. Insomnia and the risk of acute myocardial infarction: a population study. Circulation 2011, 124:2073-2081.
9. Vgontzas A.N., Liao D., Bixler E.O., Chrousos G.P., Vela-Bueno A. Insomnia with objective short sleep duration is associated with a high risk for hypertension. Sleep 2009, 32:491-497.
10. Sarsour K., Kalsekar A., Swindle R., Foley K., Walsh J.K. The association between insomnia severity and healthcare and productivity costs in a health plan sample. Sleep 2011, 34:443-450.
11. Stoller M.K. Economic effects of insomnia. Clin Ther 1994, 16:873-897. [discussion 54].
12. Walsh J.K., Engelhardt C.L. The direct economic costs of insomnia in the United States for 1995. Sleep 1999, 22(Suppl. 2):S386-S393.
13. Arendt J., Bojkowski C., Folkard S., Franey C., Marks V., Minors D., et al. Some effects of melatonin and the control of its secretion in humans. Ciba Found Symp 1985, 117:266-283.
14. Kato K., Hirai K., Nishiyama K., Uchikawa O., Fukatsu K., Ohkawa S., et al. Neurochemical properties of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology 2005, 48:301-310.
15. Liu J., Wang L.N. Ramelteon in the treatment of chronic insomnia: systematic review and meta-analysis. Int J Clin Pract 2012, 66:867-873.
16. Moher D., Liberati A., Tetzlaff J., Altman D.G., Group P Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009, 339:b2535.
17. The PRISMA Initiative. Preferred reporting items for systematic reviews and meta-analyses (PRISMA), available from <> [accessed September 7]. http://www.prisma-statement.org/.
18. Higgins J., Green S. Cochrane handbook for systematic reviews of interventions 2008, John Wiley & Sons, Ltd., Chichester, England. 1st ed.
19. Follmann D., Elliott P., Suh I., Cutler J. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol 1992, 45:769-773.
20. DerSimonian R., Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986, 7:177-188.
21. Galbraith R.F. A note on graphical presentation of estimated odds ratios from several clinical trials. Stat Med 1988, 7:889-894.
22. Higgins J.P., Thompson S.G., Deeks J.J., Altman D.G. Measuring inconsistency in meta-analyses. BMJ 2003, 327:557-560.
23. Sharp S. Meta-analysis regression. Stata Tech Bull 1998, 42:16-22.
24. Egger M., Davey Smith G., Schneider M., Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997, 315:629-634.
25. Duval S., Tweedie R. Trim and fill: a simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics 2000, 56:455-463.
26. Erman M., Seiden D., Zammit G., Sainati S., Zhang J. An efficacy, safety, and dose-response study of Ramelteon in patients with chronic primary insomnia. Sleep Med 2006, 7:17-24.
27. Gooneratne N.S., Gehrman P., Gurubhagavatula I., Al-Shehabi E., Marie E., Schwab R. Effectiveness of ramelteon for insomnia symptoms in older adults with obstructive sleep apnea: a randomized placebo-controlled pilot study. J Clin Sleep Med 2010, 6:572-580.
28. Kohsaka M., Kanemura T., Taniguchi M., Kuwahara H., Mikami A., Kamikawa K., et al. Efficacy and tolerability of ramelteon in a double-blind, placebo-controlled, crossover study in Japanese patients with chronic primary insomnia. Expert Rev Neurother 2011, 11:1389-1397.
29. Mayer G., Wang-Weigand S., Roth-Schechter B., Lehmann R., Staner C., Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. Sleep 2009, 32:351-360.
30. McElroy S.L., Winstanley E.L., Martens B., Patel N.C., Mori N., Moeller D., et al. A randomized, placebo-controlled study of adjunctive ramelteon in ambulatory bipolar I disorder with manic symptoms and sleep disturbance. Int Clin Psychopharmacol 2011, 26:48-53.
31. NCT00237497. <> 2005 [accessed 25.10.2013]. http://clinicaltrial.gov/ct2/show/NCT00237497.
32. NCT00671567. <> 2003 [accessed 25.10.2013]. http://clinicaltrial.gov/ct2/show/NCT00671567.
33. Roth T., Seiden D., Sainati S., Wang-Weigand S., Zhang J., Zee P. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med 2006, 7:312-318.
34. Roth T., Seiden D., Wang-Weigand S., Zhang J. A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia. Curr Med Res Opin 2007, 23:1005-1014.
35. Uchimura N., Ogawa A., Hamamura M., Hashimoto T., Nagata H., Uchiyama M. Efficacy and safety of ramelteon in Japanese adults with chronic insomnia: a randomized, double-blind, placebo-controlled study. Expert Rev Neurother 2011, 11:215-224.
36. Uchiyama M., Hamamura M., Kuwano T., Nishiyama H., Nagata H., Uchimura N. Evaluation of subjective efficacy and safety of ramelteon in Japanese subjects with chronic insomnia. Sleep Med 2011, 12:119-126.
37. Wang-Weigand S., Watissee M., Roth T. Use of a post-sleep questionnaire-interactive voice response system (PSQ-IVRS) to evaluate the subjective sleep effects of ramelteon in adults with chronic insomnia. Sleep Med 2011, 12:920-923.
38. Zammit G., Erman M., Wang-Weigand S., Sainati S., Zhang J., Roth T. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. J Clin Sleep Med 2007, 3:495-504.
39. Zammit G., Wang-Weigand S., Rosenthal M., Peng X. Effect of ramelteon on middle-of-the-night balance in older adults with chronic insomnia. J Clin Sleep Med 2009, 5:34-40.
40. Buscemi N., Vandermeer B., Hooton N., Pandya R., Tjosvold L., Hartling L., et al. The efficacy and safety of exogenous melatonin for primary sleep disorders. A meta-analysis. J Gen Intern Med 2005, 20:1151-1158.
41. Hirai K.K.K., Nishiyama K., Hinuma S., Uchikawa O., Ohkawa S., Miyamoto M. TAK-375 and its metabolites are selective agonists at MLs1s receptors. [Abstracts]. Sleep 2003, 26(Suppl.):A79.
42. Richardson G.S., Zee P.C., Wang-Weigand S., Rodriguez L., Peng X. Circadian phase-shifting effects of repeated ramelteon administration in healthy adults. J Clin Sleep Med 2008, 4:456-461.
43. Joya F.L., Kripke D.F., Loving R.T., Dawson A., Kline L.E. Meta-analyses of hypnotics and infections: eszopiclone, ramelteon, zaleplon, and zolpidem. J Clin Sleep Med 2009, 5:377-383.
44. Kripke D.F. Greater incidence of depression with hypnotic use than with placebo. BMC Psychiatry 2007, 7:42.
45. Mets M.A., de Vries J.M., de Senerpont Domis L.M., Volkerts E.R., Olivier B., Verster J.C. Next-day effects of ramelteon (8mg), zopiclone (7.5mg), and placebo on highway driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects. Sleep 2011, 34:1327-1334.
46. Uchiyama M., Hamamura M., Kuwano T., Nagata H., Hashimoto T., Ogawa A., et al. Long-term safety and efficacy of ramelteon in Japanese patients with chronic insomnia. Sleep Med 2011, 12:127-133.
47. Begg C., Cho M., Eastwood S., Horton R., Moher D., Olkin I., et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996, 276:637-639.