Trial reportSleep2009
Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia.
Trial report in Sleep, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00247390 (A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.), which is not on this map. Cited by 51 papers, 7 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.
A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
Who cites it
51 citing papers in PubMed, 7 syntheses or guidelines pooled it, 145 citations in OpenAlex.
- Pooled it
- Comparative efficacy of lemborexant and other insomnia treatments: a network meta-analysis.Journal of managed care & specialty pharmacy · 2021Pooled it
- Antidepressants for insomnia in adults.The Cochrane database of systematic reviews · 2018Pooled it
- Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017Guideline
- Pharmacotherapy Treatment Options for Insomnia: A Primer for Clinicians.International journal of molecular sciences · 2015Guideline
- Effect of Placebo Conditions on Polysomnographic Parameters in Primary Insomnia: A Meta-Analysis.Sleep · 2015Pooled it
- Drug treatment of primary insomnia: a meta-analysis of polysomnographic randomized controlled trials.CNS drugs · 2014Pooled it
- Trial
- Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2016Trial
- The effects of acute treatment with ramelteon, triazolam, and placebo on driving performance, cognitive function, and equilibrium function in healthy volunteers.Psychopharmacology · 2015Trial
- Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.Sleep medicine · 2015Trial
- Trial
- Trial
- Trial
- The effect of vestibular stimulation in a four-hour sleep phase advance model of transient insomnia.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2010Trial
- Effects of the melatonin MT-1/MT-2 agonist ramelteon on daytime body temperature and sleep.Sleep · 2010Trial
- Recommendations on Switching or Deprescribing Hypnotic Medications for Insomnia.Deutsches Arzteblatt international · 2026Review
- Resting after learning facilitates memory consolidation and reverses spatial reorientation impairments in female 3xTg-AD mice.Journal of Alzheimer's disease : JAD · 2026Article
- Novel hypnotics use and hip fracture risk in middle-aged and older adults: A large, population-based cohort study in Japan.PCN reports : psychiatry and clinical neurosciences · 2025Article
- Safety profile of ramelteon from the perspective of physicians and pharmacists: a 20-year real-world pharmacovigilance analysis based on the FAERS database.BMC psychiatry · 2025Article
Corrections and comments
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Authors and funding
6 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesLong-duration (> or = 6 months) polysomnographic studies of insomnia medications are lacking. This study evaluated the long-term efficacy of ramelteon, a selective MT1/MT2 melatonin-receptor agonist used for insomnia treatment.
designSix-month, randomized, double-blind, placebo-controlled study.
settingForty-six investigative sites in the United States, Europe, Russia, and Australia.
participantsFour hundred fifty-one adults (age > or = 18 years) with chronic primary insomnia.
interventionsRamelteon, 8 mg, or placebo 30 minutes before bedtime nightly for 6 months. MEASUREMENTS: Sleep was evaluated by polysomnography and morning questionnaires on the first 2 nights of Week 1; the last 2 nights of Months 1, 3, 5, and 6; and Nights 1 and 2 of the placebo run-out. Next-morning residual effects as well as adverse effects and vital signs were recorded at each visit. Rebound insomnia and withdrawal effects were evaluated during placebo run-out.
resultsOver the 6 months of treatment, ramelteon consistently reduced latency to persistent sleep compared with baseline and with placebo; significant decreases were observed at Week 1 and Months 1, 3, 5, and 6 (P < 0.05). Ramelteon significantly reduced subjective sleep latency relative to placebo at Week 1, Month 1, and Month 5 (P < 0.05), with reductions nearing statistical significance at Months 3 and 6 (P < or = 0.08). No significant next-morning residual effects were detected during ramelteon treatment. No withdrawal symptoms or rebound insomnia were detected after ramelteon discontinuation. Most adverse events were mild or moderate in severity.
conclusionsIn adults with chronic insomnia, long-term ramelteon treatment consistently reduced sleep onset, with no next-morning residual effects or rebound insomnia or withdrawal symptoms upon discontinuation.
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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.