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.

OBJECTIVE: Ramelteon is an MT(1)/MT(2) melatonin receptor agonist approved in the US and Japan for the treatment of sleep-onset insomnia. This study evaluated the effects of ramelteon 8mg on patient reported sleep parameters in adults with chronic insomnia in an at-home setting using a post-sleep questionnaire-interactive voice response system (PSQ-IVRS). METHODS: Adults aged 18-64 years with chronic insomnia were randomized to receive ramelteon 8 mg or placebo nightly for 3weeks. Sleep parameters were assessed via PSQ-IVRS within 60 min of awakening each morning. Adverse effects were collected throughout the study. RESULTS: A total of 552 subjects (mean age 43.2 years) received treatment (274 ramelteon, 278 placebo). There was a reduction in mean sleep latency at weeks 1, 2, and 3 compared with placebo but none reached statistical significance (-4.1 min, p=0.088 week 1; -2.8 min, p=0.258 week 2; -4.9 min, p=0.060 week 3). There were no significant differences between placebo and ramelteon in other PSQ-IVRS sleep parameters. Only headache (18 [6.5%] placebo, 18 [6.6%] ramelteon) and somnolence (5 [1.8%], 12 [4.4%] ramelteon) occurred in>3% of subjects. CONCLUSIONS: Use of ramelteon 8 mg in an at-home setting did not demonstrate statistically significant improvements in subjective sleep latency compared with placebo, when measured by PSQ-IVRS.