Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2007
Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00671125 (A Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults With Chronic Insomnia), which is not on this map. Cited by 48 papers, 6 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 Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults With Chronic Insomnia
Who cites it
48 citing papers in PubMed, 6 syntheses or guidelines pooled it, 196 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
- 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
- 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
- Meta-analyses of hypnotics and infections: eszopiclone, ramelteon, zaleplon, and zolpidem.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2009Pooled it
- The effects of acute treatment with ramelteon, triazolam, and placebo on driving performance, cognitive function, and equilibrium function in healthy volunteers.Psychopharmacology · 2015Trial
- Orexin receptor antagonism, a new sleep-enabling paradigm: a proof-of-concept clinical trial.Clinical pharmacology and therapeutics · 2012Trial
- Trial
- Ramelteon prior to a short evening nap impairs neurobehavioral performance for up to 12 hours after awakening.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2010Trial
- The effects of ramelteon on respiration during sleep in subjects with moderate to severe chronic obstructive pulmonary disease.Sleep & breathing = Schlaf & Atmung · 2009Trial
- Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia.Sleep · 2009Trial
- Ramelteon for the treatment of insomnia in menopausal women.Menopause international · 2009Trial
- Effect of ramelteon on middle-of-the-night balance in older adults with chronic insomnia.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2009Trial
- Ramelteon for insomnia symptoms in a community sample of adults with generalized anxiety disorder: an open label study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2009Trial
- Effect of ramelteon, a selective MT(1)/MT (2)-receptor agonist, on respiration during sleep in mild to moderate COPD.Sleep & breathing = Schlaf & Atmung · 2008Trial
- Recommendations on Switching or Deprescribing Hypnotic Medications for Insomnia.Deutsches Arzteblatt international · 2026Review
- Detailed Review of Melatonin and its Role in Managing the Symptoms of Depression.Current molecular medicine · 2026Review
- Pharmacological and psychological approaches to insomnia treatment in cardiac patients: a narrative literature review.Frontiers in psychiatry · 2025Review
- 2023 Guidelines on the Diagnosis and Treatment of Insomnia in Adults - Brazilian Sleep Association.Sleep science (Sao Paulo, Brazil) · 2023Review
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate efficacy and safety of ramelteon (MT1/MT2-receptor [corrected] agonist) in subjects with chronic primary insomnia.
methodsRandomized, multicenter, double-blind, placebo-controlled trial of nightly ramelteon treatment (8 mg or 16 mg) in adults (N=405) with primary chronic insomnia (DSM-IV-TR). Latency to persistent sleep (LPS), TST, sleep efficiency, wake time after sleep onset, and number of awakenings were measured by polysomnography. Subject-reported measures were also assessed.
resultsLPS at Week 1 (primary measure) was significantly shorter with ramelteon 8 mg (32.2 min) or 16 mg (28.9 min) vs placebo (47.9 min; p <0.001). Significant improvements in LPS were maintained at Weeks 3 and 5. TST was significantly longer with both doses of ramelteon at Week 1 (p <0.001) vs placebo. Subject-reported sleep latency was significantly shorter with ramelteon 8 mg at Weeks 1, 3, and 5 (p <0.001) and ramelteon 16 mg at Weeks 1 and 3 (p < or =0.050) vs placebo. Wake time after sleep onset and number of awakenings were not significantly different with ramelteon 8 mg or 16 mg treatment vs placebo. Subjective TST was significantly longer with ramelteon 8 mg at Weeks 1, 3, and 5 (p < or =0.050) and ramelteon 16 mg at Week 1 (p = 0.003) vs placebo. Ramelteon had no clinically meaningful effect on sleep architecture, next-morning psychomotor tasks, alertness, or ability to concentrate. No withdrawal or rebound effects were observed.
conclusionsRamelteon reduced LPS over 5 weeks of treatment in subjects with chronic insomnia, with no clinically meaningful sleep architecture alterations, next-morning residual pharmacologic effects, and no evidence of rebound insomnia or withdrawal. No numerical differences were observed between the 2 doses of ramelteon.
Indexed as
Identifiers
17803013PMC1978328W2121077521What 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.