Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2009
Ramelteon for insomnia symptoms in a community sample of adults with generalized anxiety disorder: an open label study.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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
14 citing papers in PubMed, 42 citations in OpenAlex.
- Protocol MelatoSom-Kids-PTSD: sleep disturbances in children and adolescents with post-traumatic stress disorder (PTSD) - a randomized double-blind placebo-controlled trial to investigate the efficacy of paediatric prolonged-release melatonin.European journal of psychotraumatology · 2025Article
- Melatonin as a Coadjuvant in the Treatment of Patients with Fibromyalgia.Biomedicines · 2023Review
- Article
- Article
- 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
- Evaluating the Potential Effect of Melatonin on the post-Cardiac Surgery Sleep Disorder.The journal of Tehran Heart Center · 2015Article
- Attenuation of morphine physical dependence and blood levels of cortisol by central and systemic administration of ramelteon in rat.Iranian journal of medical sciences · 2015Article
- Therapeutic effects of melatonin receptor agonists on sleep and comorbid disorders.International journal of molecular sciences · 2014Review
- ASMT gene expression correlates with cognitive impairment in patients with recurrent depressive disorder.Medical science monitor : international medical journal of experimental and clinical research · 2014Article
- Pharmacotherapy of insomnia with ramelteon: safety, efficacy and clinical applications.Journal of central nervous system disease · 2011Article
- A systematic, updated review on the antidepressant agomelatine focusing on its melatonergic modulation.Current neuropharmacology · 2010Article
- Defining and measuring functional recovery from depression.CNS drugs · 2010Review
- Critical appraisal of ramelteon in the treatment of insomnia.Nature and science of sleep · 2010Article
- Treatment of sleep dysfunction and psychiatric disorders.Current treatment options in neurology · 2009Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivePrior research confirms the relationship between insomnia and psychiatric disorders, particularly anxiety and depression. The effectiveness and tolerability of ramelteon was examined in adult generalized anxiety disorder (GAD) patients with insomnia symptoms.
methodsTwenty-seven adults with sleep disturbance meeting DSM-IV diagnostic criteria for GAD and partially responsive on an SSRI or SNRI by randomization visit (as signified by a Hamilton Anxiety scale [HAMA] maximum score of 15 and minimum of 8, Clinical Global Impressions Severity of Illness [CGI-S] scale of < or = 4 and > or = 2 [measuring anxiety symptoms], CGI-S of 4 [measuring insomnia symptoms], > or = 5 on the Pittsburgh Sleep Quality Index [PSQI], and > or = 10 on the Epworth Sleepiness Scale [ESS]) were treated openly for 10 weeks on ramelteon 8 mg at bedtime. Analysis was conducted using repeated measures methodology. Patient reported sleep diaries were maintained throughout the study.
resultsSignificant symptom reduction was observed on all scales (HAMA, ESS, CGI-I, CGI-S), with subjects falling asleep faster and sleeping longer. Headache upon stopping ramelteon, daytime tiredness, agitation, and depression were the most commonly reported side effects and were cited as transient.
conclusionData from this 12-week open-label study suggests ramelteon is an effective and generally well tolerated treatment for insomnia symptoms in this community sample of adults with GAD.
Indexed as
Identifiers
19317378PMC2637163W1692097324What 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.