Summary
Melatonin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Insomnia / Sleep Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Insomnia / Sleep Disorders. ClinicalTrials.gov lists 8 registered trials linking Melatonin to Insomnia / Sleep Disorders: 2 are currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT07542756). It plans or enrolled 1200 participants. Registration activity spans 2007 to 2026. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 3 systematic reviews and 5 clinical trial publications. Publication years run from 2023 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Insomnia ranks 317 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Acute insomnia (<3 months): 50-60% resolve spontaneously; chronic insomnia: only 20-25% spontaneous remission at 1 year; persistent insomnia in 50-75% without treatment.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 73.5 (trials 23.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 0 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 17 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 3 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02156271 | Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance 2007 | completed | Phase 4 | 75 |
| NCT07542756 | A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia 2026 | recruiting | Phase 4 | 1,200 |
| NCT04233502 | Efficacy and Safety of Slenyto for Insomnia in Children With ASD 2020 | withdrawn | Phase 3 | — |
| NCT02321449 | The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over 2014 | completed | Not applicable | 40 |
| NCT07651605 | Pistacho and Sleep Quality 2021 | completed | Not applicable | 28 |
| NCT03567395 | Honey to Improve Sleep Quality: a Feasibility Study 2018 | completed | Not applicable | 20 |
| NCT07046429 | Affect of Melatonin on Sleep and Cognition in Cirrhosis 2025 | recruiting | Not applicable | 18 |
| NCT04642313 | Comparison of Mg Vs. K Supplementation on Insomnia in Diabetics 2020 | status unknown | Not applicable | 320 |
Published literature
- Clinical trial publication Sleep aid usage following benzodiazepine receptor agonist tapering and cognitive behavioral therapy for insomnia in middle-aged and older adultsGhadimi S, Erickson AJ, Vaughan M et al. · Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026 · PMID 42168527
- Clinical trial publication Effects of bright light and near-infrared light on insomnia symptoms in community-dwelling older adults: a randomized clinical trialChen PY, Chen ST, Chen YL et al. · Photodiagnosis and photodynamic therapy · 2026 · PMID 41794313
- Clinical trial publication Efficacy of clonidine and melatonin for treating insomnia in anxious children: a randomized comparisonJalali Firouzkohi A, Behmanesh H, Doostizadeh M et al. · BMC pediatrics · 2026 · PMID 41781909
- Clinical trial publication A Pilot Randomised Controlled Trial of Sublingual Melatonin for Sleep Onset Insomnia in Children With Foetal Alcohol Spectrum Disorder (FASD)Chandler-Mather N, Shelton D, Donovan C et al. · Journal of paediatrics and child health · 2026 · PMID 41122831
- Meta-analysis Insomnia among hospitalized inpatients: A systematic review and network meta-analysisBottignole D, Balella G, Minetti M et al. · Sleep medicine reviews · 2026 · PMID 41297371
- Systematic review Interventions for Migraine and Sleep: A Systematic Review Exploring Their Bidirectional AssociationSforza M, Mariani I, Fazzini F et al. · European journal of neurology · 2026 · PMID 41874004
- Clinical trial publication Heat-Treated Limosilactobacillus fermentum PS150 Improves Sleep Quality with Severity-Dependent Benefits: A Randomized, Placebo-Controlled TrialLee MC, Chen CY, Chen CY et al. · Nutrients · 2025 · PMID 41515133
- Cochrane review Pharmacological interventions for sleep disturbance ("insomnia") in patients with advanced cancer receiving specialist palliative care: a scoping reviewRyan S, Munir S, Davies A · Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025 · PMID 41284034
- Cochrane review Efficacy and safety of insomnia pharmacotherapies: Convergent evidence from Bayesian network meta-regression and FAERS-based disproportionality analysisLiu H, Wang Y, Li M et al. · Sleep medicine · 2025 · PMID 41101148
- Cochrane review From nocturnal awakenings to nocturnal voiding: the relationship between insomnia and nocturia - a systematic reviewVerbakel I, Boukheir G, Bliwise D et al. · Minerva urology and nephrology · 2025 · PMID 37955855
- Meta-analysis Factors influencing the effect of melatonin on sleep quality in children with autism spectrum disorder: a systematic review and meta-analysisYang H, Lu F, Zhao X · Sleep & breathing = Schlaf & Atmung · 2025 · PMID 40768003
- Meta-analysis Efficacy and safety of each class of sleep medication for major depressive disorder with insomnia symptoms: A systematic review and meta-analysis of double-blind randomized controlled trialsMaruki T, Takeshima M, Yoshizawa K et al. · Psychiatry and clinical neurosciences · 2025 · PMID 40110890
- Systematic review Z-drug abuse and dependence: clinical guideline of the Brazilian Academy of Neurology for diagnosis and managementStelzer FG, Bacelar A, Éckeli AL et al. · Arquivos de neuro-psiquiatria · 2025 · PMID 41187937
- Systematic review Sleep disorders in patients with spinal cord injury: A comprehensive review of assessment strategies and available treatmentStryjewska ES, Jurga S, Pietraszkiewicz F et al. · Neurologia i neurochirurgia polska · 2025 · PMID 41182065
- Meta-analysis Optimizing the Time and Dose of Melatonin as a Sleep-Promoting Drug: A Systematic Review of Randomized Controlled Trials and Dose-Response Meta-AnalysisCruz-Sanabria F, Bruno S, Crippa A et al. · Journal of pineal research · 2024 · PMID 38888087
- Cochrane review Sleep disturbances and the risk of lung cancer: a meta-epidemiological studyZhou T, Wang Z, Qiao C et al. · BMC cancer · 2023 · PMID 37726707
- Cochrane review The Comparative Effectiveness and Safety of Insomnia Drugs: A Systematic Review and Network Meta-Analysis of 153 Randomized TrialsPan B, Ge L, Lai H et al. · Drugs · 2023 · PMID 36947394
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Melatonin approved for Insomnia / Sleep Disorders?
Melatonin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Insomnia / Sleep Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Insomnia / Sleep Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Melatonin in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 8 registered trials linking Melatonin to Insomnia / Sleep Disorders: 2 are currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT07542756). It plans or enrolled 1200 participants. Registration activity spans 2007 to 2026.
What does the evidence show for Melatonin in Insomnia / Sleep Disorders?
Melatonin has both completed registered trials and synthesis-level publications linked to Insomnia / Sleep Disorders. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.