STUDY OBJECTIVES: To evaluate the effectiveness of ramelteon, a melatonin receptor agonist, for the treatment of insomnia in older adults starting auto-titrating positive airway pressure (APAP) therapy for sleep apnea. METHODS: A parallel group, randomized, double-blind, placebo-controlled pilot effectiveness clinical trial. The study enrolled 21 research study participants who were ≥ 60 years old and had obstructive sleep apnea, defined by an apnea-hypopnea index (AHI) ≥ 5 events/h, with complaints of insomnia. The primary outcome measure was change in sleep onset latency determined from polysomnography at 4 weeks. Research study participants, all of whom were starting on APAP, were randomized to ramelteon 8 mg (n = 8) or placebo (n = 13). RESULTS:Ramelteon treatment was associated with a statistically significant difference in sleep onset latency (SOL) as measured by polysomnography of 28.5 min (± 16.2 min) compared to placebo (95% C.I. 8.5 min to 48.6 min, effect size 1.35, p = 0.008). This was due to a 10.7 (± 17.0) min SOL reduction in the ramelteon arm and a 17.8 (± 23.5) min SOL increase in the placebo arm. No change was noted in subjective sleep onset latency (-1.3 min, ± 19.3 min, 95% C.I.: -21.4 min to 18.7 min). No statistically significant changes were noted in the AHI, sleep efficiency (polysomnography and self-report), APAP adherence, Pittsburgh Sleep Quality Index global score, or Epworth Sleepiness Scale score when comparing ramelteon vs. placebo. Four adverse events occurred in the ramelteon arm and 2 in the placebo arm; none were considered to be related to treatment. CONCLUSIONS:Ramelteon was effective in improving objective, but not subjective, sleep onset latency even in older adults who were starting APAP therapy for sleep apnea. Further research is warranted in examining the role of ramelteon in the care of older adults with insomnia symptoms and sleep apnea.
RCT Entities:
STUDY OBJECTIVES: To evaluate the effectiveness of ramelteon, a melatonin receptor agonist, for the treatment of insomnia in older adults starting auto-titrating positive airway pressure (APAP) therapy for sleep apnea. METHODS: A parallel group, randomized, double-blind, placebo-controlled pilot effectiveness clinical trial. The study enrolled 21 research study participants who were ≥ 60 years old and had obstructive sleep apnea, defined by an apnea-hypopnea index (AHI) ≥ 5 events/h, with complaints of insomnia. The primary outcome measure was change in sleep onset latency determined from polysomnography at 4 weeks. Research study participants, all of whom were starting on APAP, were randomized to ramelteon 8 mg (n = 8) or placebo (n = 13). RESULTS:Ramelteon treatment was associated with a statistically significant difference in sleep onset latency (SOL) as measured by polysomnography of 28.5 min (± 16.2 min) compared to placebo (95% C.I. 8.5 min to 48.6 min, effect size 1.35, p = 0.008). This was due to a 10.7 (± 17.0) min SOL reduction in the ramelteon arm and a 17.8 (± 23.5) min SOL increase in the placebo arm. No change was noted in subjective sleep onset latency (-1.3 min, ± 19.3 min, 95% C.I.: -21.4 min to 18.7 min). No statistically significant changes were noted in the AHI, sleep efficiency (polysomnography and self-report), APAP adherence, Pittsburgh Sleep Quality Index global score, or Epworth Sleepiness Scale score when comparing ramelteon vs. placebo. Four adverse events occurred in the ramelteon arm and 2 in the placebo arm; none were considered to be related to treatment. CONCLUSIONS:Ramelteon was effective in improving objective, but not subjective, sleep onset latency even in older adults who were starting APAP therapy for sleep apnea. Further research is warranted in examining the role of ramelteon in the care of older adults with insomnia symptoms and sleep apnea.
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