Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2010
Effectiveness of ramelteon for insomnia symptoms in older adults with obstructive sleep apnea: a randomized placebo-controlled pilot study.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- Comparative effects of hypnotic agents on sleep architecture and respiratory outcomes in obstructive sleep apnea: A systematic review and network meta-analysis.Psychiatry and clinical neurosciences · 2026Pooled it
- Drug therapy for obstructive sleep apnoea in adults.The Cochrane database of systematic reviews · 2013Pooled it
- A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions.Sleep medicine reviews · 2011Pooled it
- Trial
- Melatonin mediates intestinal barrier dysfunction and systemic inflammation in moderate-severe OSA patients.Annals of medicine · 2024Article
- Effect of melatonin on insomnia and daytime sleepiness, in patients with obstructive sleep apnea and insomnia (COMISA): A randomized double-blinded placebo-controlled trial.Journal of pharmaceutical health care and sciences · 2024Article
- 2023 Guidelines on the Diagnosis and Treatment of Insomnia in Adults - Brazilian Sleep Association.Sleep science (Sao Paulo, Brazil) · 2023Review
- Do Insomnia Treatments Improve Daytime Function?Journal of clinical medicine · 2023Article
- Non-GABA sleep medications, suvorexant as risk factors for falls: Case-control and case-crossover study.PloS one · 2020Article
- Review
- Sleep disorders in the elderly: Diagnosis and management.Journal of general and family medicine · 2017Review
- Impact of concomitant medications on obstructive sleep apnoea.British journal of clinical pharmacology · 2017Review
- The Effects of Ramelteon on Glucose Metabolism and Sleep Quality in Type 2 Diabetic Patients With Insomnia: A Pilot Prospective Randomized Controlled Trial.Journal of clinical medicine research · 2016Article
- The management of sleep and circadian disturbance in patients with dementia.Current neurology and neuroscience reports · 2012Review
- A dietary supplement containing chlorophytum borivilianum and velvet bean improves sleep quality in men and women.Integrative medicine insights · 2012Article
- Pharmacotherapy of insomnia with ramelteon: safety, efficacy and clinical applications.Journal of central nervous system disease · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesTo 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.
methodsA 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).
resultsRamelteon 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.
conclusionsRamelteon 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.
Indexed as
Identifiers
21206546PMC3014244W1523775984What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.