Effectiveness of ramelteon for insomnia symptoms in older adults with obstructive sleep apnea: a randomized placebo-controlled pilot study
Gooneratne NS, Gehrman P, Gurubhagavatula I, Al-Shehabi E
Published in Journal of Clinical Sleep Medicine
Methodology
Parallel-group, randomized, double-blind, placebo-controlled pilot trial of ramelteon 8 mg (a melatonin receptor agonist) in adults aged 60+ with OSA and insomnia starting auto-titrating positive airway pressure
Key Findings
Objective sleep onset latency improved by 28.5 minutes versus placebo (95% CI 8.5-48.6, p = 0.008), but there was no change in subjective sleep onset latency, apnea-hypopnea index, sleep efficiency, PAP adherence, PSQI or Epworth Sleepiness Scale.
Conclusions
A melatonin-receptor agonist shortened objectively measured time to fall asleep without altering apnea severity or daytime sleepiness.
Limitations
Very small pilot sample (n = 21), unbalanced arms, four-week duration
Supplements Studied
Ramelteon treatment was associated with a statistically significant difference in sleep onset latency (SOL) as measured by polysomnography of 28.5 min compared to placebo
Outcomes Measured
No statistically significant changes were noted in the AHI, sleep efficiency, APAP adherence, Pittsburgh Sleep Quality Index global score, or Epworth Sleepiness Scale score when comparing ramelteon vs. placebo
Study Details
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