4
40
17
↑4
↓40
—17
Evidence suggests Melatonin maydecreaseInsomnia.
70 studies (61 claims)
Moderate consensus
Typical effective dose 3 (2–8) mgacross 15 dosed studies
Study Claims
| Intervention | Direction | Endpoint | Type | Population | Dosage | Title |
|---|---|---|---|---|---|---|
| melatonin receptor agonist ramelteon | No effect - approved to treat | insomnia | Human | — | Not specified | An update of management of insomnia in patients with chronic orofacial pain.cited 11× |
| melatonin receptor agonist-ramelteon | No effect - are the agents of choice | treatment of primary and comorbid insomnia | Human | patients with primary and comorbid insomnia | Not specified | Selecting a pharmacotherapy regimen for patients with chronic insomnia.cited 11× |
| melatonin receptor agonist | No effect - FDA-approved medications for insomnia | insomnia | Human | — | Not specified | Chronic Insomnia Disorder.cited 14× |
| melatonin receptor agonist | No effect - approved | insomnia treatment | Human | — | Not provided. | New and emerging pharmacotherapeutic approaches for insomnia.cited 22× |
| melatonin receptor agonist | No effect - FDA-approved | treatment of insomnia | Human | — | Not specified | Chronic insomnia.cited 10× |
| pediatric prolonged-release melatonin (PedPRM) | Decreases - demonstrated efficacy and safety | insomnia | Human | children with autism spectrum disorder | 2 mg, 5 mg, or 10 mg nightly | Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder.cited 63× |
| melatonin receptor agonists such as ramelteon and tasimelteon | No effect - are considered by the American Academy of Family Physicians for the treatment of | insomnia | Human | — | — | Melatonin: Translation of Ongoing Studies Into Possible Therapeutic Applications Outside Sleep Disorders.cited 6× |
| Melatonin | Decreases - appears to be effective in treating | chronic insomnia | Human | children with ADHD | Not available | Nutritional supplements for the treatment of ADHD.cited 23× |
| melatonin | No effect - regulates | circadian rhythm sleep disorders such as sleep-onset insomnia (SOI) | Human | children with ADHD | 3 to 6 mg administered within a few hours of bedtime. | Melatonin treatment for insomnia in pediatric patients with attention-deficit/hyperactivity disorder.cited 61× |
| melatonin | No effect - is registered to treat | circadian rhythm sleep-wake disorders and insomnia | Human | patients aged 55 years and over | Not specified | Melatonin as a Potential Adjuvant Treatment for COVID-19 beyond Sleep Disorders.cited 22× |
| melatonin | Decreases - improving | insomnia | Human | atopic dermatitis patients | Not specified | Clinical Pearls on Sleep Management in Atopic Dermatitis.cited 9× |
| melatonin | No effect - might be beneficial | insomnia | Human | patients with Parkinson's disease | Not available | Treatment of the sleep disorders associated with Parkinson's disease.cited 38× |
| melatonin | Decreases - has shown promising results | insomnia | Human | children with ASD | Not specified | Epidemiology and management of insomnia in children with autistic spectrum disorders.cited 43× |
| melatonin and behavioral techniques | Decreases - has been suggested | insomnia | Human | children with ASDs | Not specified | Epidemiology and management of insomnia in children with autistic spectrum disorders.cited 43× |
| melatonin | No effect - efficacy | insomnia | Human | adults and children | Not specified | The use and misuse of exogenous melatonin in the treatment of sleep disorders.cited 21× |
| melatonin | No effect - little scientific evidence is available that supports any benefit of | insomnia | Human | — | Not specified | Melatonin in sleep disorders.cited 14× |
| melatonin | No effect - can be administered orally, which has led to interest in its use as a treatment for | insomnia | Human | — | — | Melatonin in sleep disorders.cited 48× |
| melatonin | Decreases - indicates long-term efficacy and safety | insomnia | Human | pediatric settings | Not specified | Insomnia in children affected by autism spectrum disorder: The role of melatonin in treatment.cited 2× |
| melatonin-based formulations | Decreases - are effective and safe | ASD-related insomnia | Human | children with ASD | Not specified | Insomnia in children affected by autism spectrum disorder: The role of melatonin in treatment.cited 2× |
| a combination of behavioral and pharmacological methods, primarily melatonin | Decreases - recommend managing | insomnia and sleep disturbances in ASD | Human | — | Not specified | Insomnia in children affected by autism spectrum disorder: The role of melatonin in treatment.cited 2× |
| prolonged-release melatonin | Decreases - is poised to be the optimal choice | insomnia | Human | this patient population | Not specified | Insomnia in children affected by autism spectrum disorder: The role of melatonin in treatment.cited 2× |
| prolonged-release melatonin | Decreases - is approved for the treatment | insomnia | Human | children and adolescents aged 2-18 years suffering from ASD and/or Smith-Magenis syndrome | Not specified | Insomnia in children affected by autism spectrum disorder: The role of melatonin in treatment.cited 2× |
| melatonin | No effect - had more substantive evidence | insomnia | Human | older adults | Not specified | A scoping review of over-the-counter products for depression, anxiety and insomnia in older people.cited 2× |
| Melatonin | Decreases - further intervention | insomnia | Human | Parkinson's disease patients | Not specified | Pharmacological and non-pharmacological management of sleep disturbances in Parkinson's disease: if when and how. |
| melatonin | Decreases - some efficacy data have been reported | insomnia | Human | patients with cancer | Not specified | Proposal for Managing Cancer-Related Insomnia: A Systematic Literature Review of Associated Factors and a Narrative Review of Treatment.cited 2× |
| Melatonin | Decreases - may demonstrate effectiveness in addressing insomnia | insomnia | Human | — | Not specified | Insomnia in neurological disorders: Prevalence, mechanisms, impact and treatment approaches.cited 14× |
| melatonin | Decreases - showed benefits | insomnia severity | Human | adult cancer patients and survivors | Not specified | Interventions for insomnia in cancer patients and survivors-a comprehensive systematic review and meta-analysis.cited 9× |
| melatonin | Decreases - could be used as an adjuvant treatment | insomnia symptoms | Human | patients during acute phases | 0.125mg (small dose mentioned for chronobiotic action; dose-effect relationship noted for sleep-inducing effects). | The use of melatonin in adult psychiatric disorders: Expert recommendations by the French institute of medical research on sleep (SFRMS).cited 35× |
| Melatonin | No effect - not recommended | insomnia treatment | Human | — | Not specified | European guideline for the diagnosis and treatment of insomnia.cited 1,152× |
| melatonin | No effect - can be safe and effective | pediatric insomnia and sleep disturbances | Human | children | Not specified (individualized based on severity and type of disorder). | Pediatric sleep disturbances and treatment with melatonin.cited 60× |
| melatonin (5 mg) | No effect - no statistically significant between-group differences | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ-1) | Human | males 18 years of age and older in recovery from substance use | 5 mg melatonin daily. | The Effect of Melatonin Upon Postacute Withdrawal Among Males in a Residential Treatment Program (M-PAWS): A Randomized, Double-blind, Placebo-controlled Trial.cited 3× |
| melatonin | No effect - will be preferentially treated | primary insomnia | Human | Patients suffering from primary insomnia | Not specified | Sleep disturbances in menopausal women: Aetiology and practical aspects.cited 37× |
| melatonin | Increases - will be preferentially improved | Primary insomnia | Human | — | Not available | An integrated approach to diagnosing and managing sleep disorders in menopausal women.cited 31× |
| melatonin | No effect - was an effective and tolerable drug | sleep onset insomnia | Human | children and adolescents | Not specified | Efficacy and safety of melatonin for sleep onset insomnia in children and adolescents: a meta-analysis of randomized controlled trials.cited 46× |
| melatonin | Decreases - best evidence for efficacy | sleep onset insomnia | Human | children | Most effective when administered 3-5 h before physiological dim light melatonin onset; no advantage of extended-release over immediate-release noted. | Current role of melatonin in pediatric neurology: clinical recommendations.cited 155× |
| melatonin | No effect - suggest that clinicians not use | sleep onset or sleep maintenance insomnia | Human | adults | Not specified | Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.cited 751× |
| melatonin | Decreases - yielded significant results | subjective and objective insomnia symptoms | Human | — | Not specified | An algorithmic approach to the management of insomnia in patients with schizophrenia.cited 6× |
| Melatonin | Decreases - could be used as an adjuvant treatment | symptoms of insomnia associated with depression | Human | — | Not specified | Biological rhythms and chronotherapeutics in depression.cited 45× |
| Exogenous melatonin | No effect - appears to have modest efficacy in treating | insomnia and circadian rhythm sleep-wake disorders | Human | — | — | Current Insights into the Risks of Using Melatonin as a Treatment for Sleep Disorders in Older Adults.cited 21× |
| Exogenous melatonin | Decreases - has demonstrated efficacy in treating | primary insomnia | Human | — | Not specified | Melatonin and Melatonin Agonists as Adjunctive Treatments in Bipolar Disorders.cited 43× |
| paediatric prolonged-release melatonin (PedPRM) | Decreases - has shown significant beneficial effects | insomnia disorders | Human | children with autism spectrum disorders | Not specified in the abstract. | 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. |
| mirtazapine followed by long-acting melatonin | Decreases - may be considered | insomnia | Human | perimenopausal women | Not available | Treatment of chronic insomnia disorder in menopause: evaluation of literature.cited 45× |
| prolonged-release melatonin formulation (PRM; Circadin 2 mg) | No effect - no withdrawal symptoms or rebound insomnia were detected | withdrawal symptoms, rebound insomnia | Human | insomnia patients | 2 mg once daily, 2 hours before bedtime. | Prolonged release melatonin in the treatment of primary insomnia: evaluation of the age cut-off for short- and long-term response.cited 72× |
| Melatonin in a prolonged-release form | Decreases - is also indicated | insomnia | Human | people over 65 years of age | Not specified | Treatment of insomnia in older adults. Recommendations of the Polish Sleep Research Society, Polish Society of Family Medicine and the Polish Psychiatric Association.cited 1× |
| deficient melatonin rhythm | No effect - emerged as potentially useful diagnostic instruments | diagnosis of insomnia | Human | — | Not specified | The potential of biomarkers for diagnosing insomnia: Consensus statement of the WFSBP Task Force on Sleep Disorders.cited 12× |
| melatonin treatment | Decreases - clinically meaningful effects have been demonstrated | circadian rhythm-related sleep disorders, jet lag and shift work, insomnia in children with neurodevelopmental disorders, poor (non-restorative) sleep quality, non-dipping nocturnal blood pressure (nocturnal hypertension) and Alzheimer's disease (AD) | Human | humans | Not specified | New perspectives on the role of melatonin in human sleep, circadian rhythms and their regulation.cited 455× |
| Melatonin treatment | Decreases - was mainly effective in reducing | insomnia symptoms | Human | children with autism spectrum disorders, aged 4-10 years, suffering from sleep onset insomnia and impaired sleep maintenance | Not specified | Controlled-release melatonin, singly and combined with cognitive behavioural therapy, for persistent insomnia in children with autism spectrum disorders: a randomized placebo-controlled trial.cited 152× |
| melatonin agonists | Decreases - have their benefits and risks | insomnia | Human | alcohol-dependent adults | Not specified | Assessment and treatment of insomnia in adult patients with alcohol use disorders.cited 84× |
| Short- or longer-term treatment with melatonin PR 2 mg | No effect - was not associated with | dependence, tolerance, rebound insomnia or withdrawal symptoms | Human | — | 2 mg, 1-2 hours before bedtime. | Melatonin prolonged release: in the treatment of insomnia in patients aged ≥55 years.cited 35× |
| oral melatonin | Decreases - statistically significant improvements in insomnia | insomnia | Human | cancer patients | 200 mg, taken once daily two hours before bedtime | Comparison Between Efficacy of Oral Melatonin and Oral L-theanine in Improving Sleep in Cancer Patients Suffering From Insomnia: A Randomised Double-blinded Placebo-controlled Study.cited 2× |
| Supplemental melatonin | Decreases - has shown promise in treating | sleep onset insomnia | Human | children with autism spectrum disorders (ASD) | 1 or 3 mg | Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes.cited 146× |
| melatonin 2 mg prolonged release | No effect - should be used | insomnia treatment | Human | adults ≥ 55 years | 2 mg prolonged release. | Evaluation and management of insomnia in the clinical practice in Italy: a 2023 update from the Insomnia Expert Consensus Group.cited 10× |
| Prolonged-release melatonin (PRM) | Decreases - suggesting a further potential role in | insomnia associated with various organic diseases | Human | — | Not specified | The use of prolonged-release melatonin in circadian medicine: a systematic review.cited 1× |
| oral prolonged-release tablet (PR form) melatonin | No effect - suitable for the treatment of insomnia | insomnia | Human | — | 1.9 mg (PR tablet) or 1 mg (IR spray) | Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers.cited 4× |
| fluoxetine (20 mg in the morning) and melatonin (5 mg in the evening) | Decreases - decreased | insomnia severity index (ISI) | Human | overweight postmenopausal women, aged 54 - 65 years, with increased appetite | 5 mg melatonin in the evening, daily. | Effects of fluoxetine and melatonin on mood, sleep quality and body mass index in postmenopausal women.cited 38× |
| 0.5 mg fast-release melatonin combined with behavioural sleep-wake scheduling | Decreases - decreased | insomnia severity | Human | clinically diagnosed DSWPD patients with delayed melatonin rhythm relative to DBT | 0.5 mg fast-release melatonin, taken 1 hour before desired bedtime for at least 5 consecutive nights per week. | Efficacy of melatonin with behavioural sleep-wake scheduling for delayed sleep-wake phase disorder: A double-blind, randomised clinical trial.cited 71× |
| melatonin supplementation | Decreases - were significantly lower | Athens insomnia scale (AIS) scores | Human | gCP patients with primary insomnia | 10 mg oral melatonin capsule once daily before bedtime. | Is dietary melatonin supplementation a viable adjunctive therapy for chronic periodontitis?-A randomized controlled clinical trial.cited 36× |
| melatonin receptor agonists | No effect - incorporated as an alternative for treatment | insomnia | Human | — | Not specified | An Update on Assessment, Therapeutic Management, and Patents on Insomnia.cited 10× |
| exogenous melatonin supplementation | No effect - had no effect | insomnia symptoms and severity on the ESS | Human | middle-aged patients with primary insomnia | 3 mg fast-release melatonin daily, taken 1 hour before bedtime. | Efficacy of melatonin for sleep disturbance in middle-aged primary insomnia: a double-blind, randomised clinical trial.cited 28× |
| exogenous melatonin supplementation | No effect - had no effect | insomnia symptoms and severity on the ISI | Human | middle-aged patients with primary insomnia | 3 mg fast-release melatonin daily, taken 1 hour before bedtime. | Efficacy of melatonin for sleep disturbance in middle-aged primary insomnia: a double-blind, randomised clinical trial.cited 28× |
| exogenous melatonin supplementation | No effect - had no effect | insomnia symptoms and severity on the PSQI | Human | middle-aged patients with primary insomnia | 3 mg fast-release melatonin daily, taken 1 hour before bedtime. | Efficacy of melatonin for sleep disturbance in middle-aged primary insomnia: a double-blind, randomised clinical trial.cited 28× |
| an abnormal melatonin rhythm | Increases - may contribute to | depression and insomnia | Human | — | Not specified | A new perspective in Oral health: potential importance and actions of melatonin receptors MT1, MT2, MT3, and RZR/ROR in the oral cavity. |
| an abnormal melatonin rhythm | Increases - may contribute to | depression and insomnia | Human | — | Not specified | A new perspective in Oral health: potential importance and actions of melatonin receptors MT1, MT2, MT3, and RZR/ROR in the oral cavity. |
| melatonin 50 mg | No effect - insufficient evidence | insomnia | Human | patients with Parkinson's disease | 3-5 mg and 50 mg (frequency not specified). | The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease.cited 587× |
| melatonin 3 to 5 mg | No effect - insufficient evidence | insomnia | Human | patients with Parkinson's disease | 3-5 mg and 50 mg (frequency not specified). | The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease.cited 587× |
| melatonin trials | Decreases - show promise | insomnia | Human | children who have ASD | Not specified | A practice pathway for the identification, evaluation, and management of insomnia in children and adolescents with autism spectrum disorders.cited 127× |
| controlled-release melatonin | No effect - recommended as first-line agent | insomnia treatment | Human | older adults | Not specified | Insomnia: Pharmacologic Therapy.cited 65× |
| exogenous oral melatonin | Decreases - highly significant improvement | Insomnia Severity Index (ISI) | Human | melatonin-treated patients | — | Study of Exogenous Melatonin as a Treatment Modality for Sleep and Psychiatric Disorders in Hemodialysis Patients.cited 3× |
| fast-release melatonin | No effect - not recommended | insomnia treatment | Human | — | Not specified | The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023.cited 206× |
| low-dose melatonin | Decreases - might be helpful | sleep onset insomnia | Human | children over 2 years old | Low-dose melatonin, administered 30-60 minutes before bedtime (specific dose not specified). | European expert guidance on management of sleep onset insomnia and melatonin use in typically developing children.cited 7× |
| low-dose melatonin | Decreases - is a useful strategy for managing | sleep onset insomnia | Human | healthy children who have not improved or have responded insufficiently to sleep hygiene and behavioral interventions | Low-dose melatonin, administered 30-60 minutes before bedtime (specific dose not specified). | European expert guidance on management of sleep onset insomnia and melatonin use in typically developing children.cited 7× |
| prolonged-release (PR) melatonin 2 mg | Decreases - were reduced | Daytime sleepiness and insomnia symptoms | Human | patients with video-polysomnography-confirmed iRBD | 2 mg prolonged-release melatonin, taken 30 minutes before bedtime. | Comparative efficacy of prolonged-release melatonin versus clonazepam for isolated rapid eye movement sleep behavior disorder.cited 8× |
| melatonin slow release preparations | Decreases - were introduced for treatment of insomnia | insomnia | Human | — | Not specified | Melatonergic drugs for therapeutic use in insomnia and sleep disturbances of mood disorders. |
| melatonin slow release preparations | Decreases - were introduced for treatment of insomnia | insomnia | Human | — | Not specified | Melatonergic drugs for therapeutic use in insomnia and sleep disturbances of mood disorders. |
| melatonin and melatonin receptor agonists | Decreases - recommendations formulated regarding the use | insomnia disorder | Human | — | Not specified | Making sleep easier: pharmacological interventions for insomnia.cited 29× |
| oral melatonin administration | Increases - had a significant effect on | sleep quality and insomnia | Human | patients with cancer | 3 mg to 20 mg, usually taken nightly before bedtime | The effect of melatonin on sleep quality and insomnia in patients with cancer: a systematic review study.cited 23× |