Effect of ramelteon on insomnia severity: evaluation of patient characteristics affecting treatment response

Abstract

We conducted a multicenter, open-label, observational study to evaluate the effectiveness and safety of ramelteon in patients with insomnia, and patient characteristics affecting treatment response in routine clinical practice. Eligible patients were aged ≥ 20 years, had a diagnosis of insomnia with difficulty falling asleep, and were scheduled to receive ramelteon 8 mg/day for 12 weeks. The primary objective was to evaluate the relationship between changes in insomnia severity [measured by the Insomnia Severity Index (ISI)] and patient characteristics. Changes in the physical (PCS-8) and mental (MCS-8) components of the Short Form-8 (SF-8), and safety were also investigated. 1527 patients received therapy; 40.5% were aged ≥ 65 years and 29.7, 56.9, and 13.4% had mild, moderate, or severe insomnia, respectively. At week 12, significant improvements in ISI score [mean change (standard deviation) from baseline, − 5.0 points (6.3); p < .0001], PCS-8 score [+ 2.40 points (8.71); p < .0001], and MCS-8 score [+ 3.68 points (9.47); p < .0001] were observed. Factors affecting ISI response or remission (based on adjusted odds ratios) included age ≥ 75 years, shorter disease duration, no alcohol intake, being employed full time, not taking concomitant medication for insomnia, and taking ramelteon more than 1 h before bedtime. In total, 5.9% of patients reported adverse drug reactions. In routine clinical practice, 12 weeks' therapy with ramelteon was effective at improving insomnia severity, with no new safety concerns identified. Several patient characteristics were found to influence response to therapy. Clinical trial identifier: UMIN000013271

Use of Melatonin and/on Ramelteon for the Treatment of Insomnia in Older Adults: A Systematic Review and Meta-Analysis

“…Liu et al [ 44 ] is a systematic review and a meta-analysis that included studies published up to 2011 and only included RCTs focused on ramelteon only versus placebo among adults. While a 2014 meta-analysis [ 17 ] addressed efficacy and safety of ramelteon in adults and another Ferracioli-Oda et al [ 19 ] is a meta-analysis that addressed melatonin usage in adults and children with primary sleep disorders, neither search went beyond 2012. In comparison, the current systematic review and meta-analyses included all studies using comparative design involving older adults, a high-risk population with insomnia with searches conducted to 2021.…”

“…Ramelteon is a novel melatonin MT1 and MT2 receptor subtypes agonist that has specific effects on melatonin receptors in the suprachiasmatic nucleus [ 16 ]. Clinical investigations and post-marketing surveillance of ramelteon have found this drug be to be safe in patients with insomnia [ 17 ].…”

Acupuncture for patients with insomnia and predictors of treatment response: a chart review

“…This may have been because comorbid depression was rare and baseline anxiety/depression scores were not high among the patients included in our study. In another observational study of ramelteon for insomnia, 29 patients aged ⩾75 years showed a higher OR Acupuncture in Medicine, 42 (2) for responders versus non-responders. Moreover, patients with severe insomnia showed a higher tendency to respond.…”

Measures of Sleep in Rheumatologic Diseases: Sleep Quality Patient‐Reported Outcomes in Rheumatologic Diseases

“…The ISI showed a mean score reduction of −5.0 points in 1527 patients in an open‐label trial of ramelteon over 12 weeks (145). In a randomized double‐blind control trial, among patients receiving eszopiclone, the mean ISI score decreased from 17.9 points to 8.3 points (improvement), whereas in patients on a placebo, the ISI score decreased from a mean of 17.8 points to 12.9 points at 6 months ( P < 0.0001 for the difference between groups) (146).…”