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