{"shortAnswer":"Melatonin is in Category 1: pharmacies may use it while FDA decides, which is not approval. Pills and gummies you swallow are sold as dietary supplements. The evidence grade is moderate-human: small gains in sleep. Reports of children swallowing it rose 530% from 2012 to 2021.","url":"https://peptideindex.ai/compound/melatonin","status":"category-1","statusCheckedAt":"2026-10-26T13:39:16.273Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T13:39:16.306Z","primarySourceUrl":"https://www.fda.gov/media/94155/download","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"d061fcbc-4c8e-484c-afc4-74d00f0af574","object":"compound","slug":"melatonin","name":"Melatonin","attrs":{"name":"Melatonin","class":"non-peptide","access":[{"type":"dietary-supplement","detail":"Pills and gummies you swallow are sold as dietary supplements. FDA calls melatonin a dietary supplement. FDA does not approve a supplement before it is sold.","source_url":"https://www.fda.gov/media/193344/download"},{"type":"lawful-compounding","detail":"A pharmacy may compound melatonin on a prescription because it is in Category 1. A compounded product is not FDA-approved.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"type":"clinical-trial","detail":"A trial in Iowa is recruiting older adults to test melatonin on memory and Alzheimer's markers. The trials block lists open trials.","source_url":"https://clinicaltrials.gov/study/NCT03954899"}],"trials":[{"nct":"NCT07418554","url":"https://clinicaltrials.gov/study/NCT07418554","phase":"Phase 3","title":"Sleep Disturbances in Children and Adolescents With Post-traumatic Stress Disorder (PTSD): a Randomized Double-blind Placebo-controlled Trial to Investigate the Efficacy of Pediatric Prolonged-release Melatonin","status":"not-yet-recruiting","sponsor":"University Hospital, Strasbourg, France","countries":["France"],"us_states":[]},{"nct":"NCT07334197","url":"https://clinicaltrials.gov/study/NCT07334197","phase":"Not applicable","title":"Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy","status":"not-yet-recruiting","sponsor":"Tanta University","countries":[],"us_states":[]},{"nct":"NCT07842900","url":"https://clinicaltrials.gov/study/NCT07842900","phase":"Not applicable","title":"Oral Melatonin as Adjunctive Therapy in Adults With Atopic Dermatitis","status":"not-yet-recruiting","sponsor":"Can Tho University of Medicine and Pharmacy","countries":[],"us_states":[]},{"nct":"NCT07651514","url":"https://clinicaltrials.gov/study/NCT07651514","phase":"Not applicable","title":"The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps","status":"recruiting","sponsor":"StudySetGo","countries":["United States"],"us_states":["Alabama","Arkansas","Florida","Georgia","North Carolina","South Carolina","Tennessee"]},{"nct":"NCT07863232","url":"https://clinicaltrials.gov/study/NCT07863232","phase":"Not applicable","title":"Melatonin and Immunonutrition for Pain Relief in Fibromyalgia","status":"recruiting","sponsor":"University of Thessaly","countries":["Greece"],"us_states":[]},{"nct":"NCT07813936","url":"https://clinicaltrials.gov/study/NCT07813936","phase":"Not applicable","title":"Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis","status":"not-yet-recruiting","sponsor":"Alexandria University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07691996","url":"https://clinicaltrials.gov/study/NCT07691996","phase":"Phase 4","title":"Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU","status":"not-yet-recruiting","sponsor":"Rutgers, The State University of New Jersey","countries":[],"us_states":[]},{"nct":"NCT07576764","url":"https://clinicaltrials.gov/study/NCT07576764","phase":"Phase 3","title":"Pediatric Prolonged-Release Melatonin for Sleep Disturbances in Children and Adolescents With Anorexia Nervosa (MELSom-ANOREXIA)","status":"not-yet-recruiting","sponsor":"Assistance Publique Hopitaux De Marseille","countries":["France"],"us_states":[]},{"nct":"NCT07732725","url":"https://clinicaltrials.gov/study/NCT07732725","phase":"Early phase 1","title":"Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty","status":"not-yet-recruiting","sponsor":"Benha University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07695246","url":"https://clinicaltrials.gov/study/NCT07695246","phase":"Not applicable","title":"Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia","status":"recruiting","sponsor":"The University of Hong Kong","countries":["Hong Kong"],"us_states":[]},{"nct":"NCT07721324","url":"https://clinicaltrials.gov/study/NCT07721324","phase":"Phase 2/Phase 3","title":"Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients","status":"not-yet-recruiting","sponsor":"Ain Shams University","countries":["Egypt"],"us_states":[]},{"nct":"NCT06489327","url":"https://clinicaltrials.gov/study/NCT06489327","phase":"Not applicable","title":"Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery","status":"recruiting","sponsor":"Al-Azhar University","countries":["Egypt","Iraq"],"us_states":[]},{"nct":"NCT07652801","url":"https://clinicaltrials.gov/study/NCT07652801","phase":"Phase 3","title":"COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHLOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE","status":"not-yet-recruiting","sponsor":"University of Child Health Sciences and Children's Hospital, Lahore","countries":[],"us_states":[]},{"nct":"NCT07221968","url":"https://clinicaltrials.gov/study/NCT07221968","phase":"Phase 2","title":"Melatonin for the Treatment of DEE-SWAS","status":"not-yet-recruiting","sponsor":"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.","countries":[],"us_states":[]},{"nct":"NCT07336277","url":"https://clinicaltrials.gov/study/NCT07336277","phase":"Phase 3","title":"Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients","status":"recruiting","sponsor":"Emory University","countries":["United States"],"us_states":["Georgia"]},{"nct":"NCT07472075","url":"https://clinicaltrials.gov/study/NCT07472075","phase":"Phase 2","title":"Melatonin Versus Placebo for Bipolar Disorder","status":"recruiting","sponsor":"Lars Vedel Kessing","countries":["Denmark"],"us_states":[]},{"nct":"NCT07617922","url":"https://clinicaltrials.gov/study/NCT07617922","phase":"Phase 2","title":"Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms","status":"recruiting","sponsor":"Beni-Suef University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07553143","url":"https://clinicaltrials.gov/study/NCT07553143","phase":"Not applicable","title":"Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy","status":"recruiting","sponsor":"Armed Forces Medical Institute Bangladesh","countries":["Bangladesh"],"us_states":[]},{"nct":"NCT07542756","url":"https://clinicaltrials.gov/study/NCT07542756","phase":"Phase 4","title":"A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia","status":"recruiting","sponsor":"University of Pennsylvania","countries":["United States"],"us_states":["Pennsylvania"]},{"nct":"NCT07503600","url":"https://clinicaltrials.gov/study/NCT07503600","phase":"Phase 3","title":"The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections","status":"not-yet-recruiting","sponsor":"Ain Shams University","countries":[],"us_states":[]},{"nct":"NCT07495605","url":"https://clinicaltrials.gov/study/NCT07495605","phase":"Not applicable","title":"Effect of 1% Melatonin Gel Versus Calcium Hydroxide as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp.","status":"not-yet-recruiting","sponsor":"Cairo University","countries":[],"us_states":[]},{"nct":"NCT07336095","url":"https://clinicaltrials.gov/study/NCT07336095","phase":"Phase 3","title":"Melatonin vs Midazolam in Children Undergoing Tonsillectomy","status":"not-yet-recruiting","sponsor":"Ain Shams University","countries":[],"us_states":[]},{"nct":"NCT07369284","url":"https://clinicaltrials.gov/study/NCT07369284","phase":"Phase 2","title":"Melatonin for Glycemic Control in Gestational Diabetes Mellitus","status":"not-yet-recruiting","sponsor":"Obstetrics & Gynecology Hospital of Fudan University","countries":[],"us_states":[]},{"nct":"NCT07120880","url":"https://clinicaltrials.gov/study/NCT07120880","phase":"Phase 3","title":"Efficacy of Chronotherapeutic Combination for Major Depressive Episode With Insomnia","status":"recruiting","sponsor":"Assistance Publique - Hôpitaux de Paris","countries":["France"],"us_states":[]},{"nct":"NCT07344467","url":"https://clinicaltrials.gov/study/NCT07344467","phase":"Not applicable","title":"Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery","status":"recruiting","sponsor":"Tanta University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07375342","url":"https://clinicaltrials.gov/study/NCT07375342","phase":"Not applicable","title":"Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric","status":"recruiting","sponsor":"Benha University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07869030","url":"https://clinicaltrials.gov/study/NCT07869030","phase":"Not applicable","title":"Melatonin Effect on Immediate Dental Implants in the Posterior Mandible","status":"recruiting","sponsor":"Future University in Egypt","countries":["Egypt"],"us_states":[]},{"nct":"NCT07554716","url":"https://clinicaltrials.gov/study/NCT07554716","phase":"Not applicable","title":"Chronobiology and Enteral Nutrition","status":"recruiting","sponsor":"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","countries":["Spain"],"us_states":[]},{"nct":"NCT07096635","url":"https://clinicaltrials.gov/study/NCT07096635","phase":"Not applicable","title":"Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction","status":"not-yet-recruiting","sponsor":"Assiut University","countries":[],"us_states":[]},{"nct":"NCT07036367","url":"https://clinicaltrials.gov/study/NCT07036367","phase":"Phase 4","title":"The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery","status":"recruiting","sponsor":"Al-Azhar University","countries":["Egypt","Iraq"],"us_states":[]},{"nct":"NCT07046429","url":"https://clinicaltrials.gov/study/NCT07046429","phase":"Not applicable","title":"Affect of Melatonin on Sleep and Cognition in Cirrhosis","status":"recruiting","sponsor":"Weill Medical College of Cornell University","countries":["United States"],"us_states":["New York"]},{"nct":"NCT07036796","url":"https://clinicaltrials.gov/study/NCT07036796","phase":"Phase 2","title":"Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy","status":"recruiting","sponsor":"Ain Shams University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07067307","url":"https://clinicaltrials.gov/study/NCT07067307","phase":"Phase 1/Phase 2","title":"Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy","status":"not-yet-recruiting","sponsor":"Mansoura University","countries":["Egypt"],"us_states":[]},{"nct":"NCT06802913","url":"https://clinicaltrials.gov/study/NCT06802913","phase":"Early phase 1","title":"A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study","status":"recruiting","sponsor":"Woolcock Institute of Medical Research","countries":["Australia"],"us_states":[]},{"nct":"NCT07345715","url":"https://clinicaltrials.gov/study/NCT07345715","phase":"Not applicable","title":"Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy","status":"recruiting","sponsor":"Tanta University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07850934","url":"https://clinicaltrials.gov/study/NCT07850934","phase":"Not applicable","title":"Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates","status":"recruiting","sponsor":"Ain Shams University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07003243","url":"https://clinicaltrials.gov/study/NCT07003243","phase":"Phase 1","title":"Effectiveness of Topical Application of Melatonin On Bone Density and Implant Stability In Immediate Implantation","status":"not-yet-recruiting","sponsor":"University of Baghdad","countries":["Iraq"],"us_states":[]},{"nct":"NCT06826755","url":"https://clinicaltrials.gov/study/NCT06826755","phase":"Not applicable","title":"Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial","status":"recruiting","sponsor":"Mayo Clinic","countries":["United States"],"us_states":["Minnesota"]},{"nct":"NCT06996171","url":"https://clinicaltrials.gov/study/NCT06996171","phase":"Not applicable","title":"Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia","status":"recruiting","sponsor":"CMH Kharian Medical College","countries":["Pakistan"],"us_states":[]},{"nct":"NCT06949904","url":"https://clinicaltrials.gov/study/NCT06949904","phase":"Phase 1/Phase 2","title":"The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia","status":"recruiting","sponsor":"Mian Muhammad Hassan Ahmed","countries":["Pakistan"],"us_states":[]},{"nct":"NCT06935292","url":"https://clinicaltrials.gov/study/NCT06935292","phase":"Phase 2/Phase 3","title":"Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients","status":"not-yet-recruiting","sponsor":"Tanta University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07737665","url":"https://clinicaltrials.gov/study/NCT07737665","phase":"Phase 4","title":"Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission","status":"recruiting","sponsor":"Mahidol University","countries":["Thailand"],"us_states":[]},{"nct":"NCT07307677","url":"https://clinicaltrials.gov/study/NCT07307677","phase":"Not applicable","title":"Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin","status":"recruiting","sponsor":"Mst.Sumyara Khatun","countries":["Bangladesh"],"us_states":[]},{"nct":"NCT06768749","url":"https://clinicaltrials.gov/study/NCT06768749","phase":"Not applicable","title":"The Impact of Melatonin Lotion on Sleep and Mental Health","status":"recruiting","sponsor":"University of Redlands","countries":["United States"],"us_states":["California"]},{"nct":"NCT06846086","url":"https://clinicaltrials.gov/study/NCT06846086","phase":"Phase 3","title":"Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy","status":"recruiting","sponsor":"Tanta University","countries":["Egypt"],"us_states":[]},{"nct":"NCT06809751","url":"https://clinicaltrials.gov/study/NCT06809751","phase":"Phase 2/Phase 3","title":"Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy","status":"not-yet-recruiting","sponsor":"Mohsen Pourazizi","countries":[],"us_states":[]},{"nct":"NCT06777342","url":"https://clinicaltrials.gov/study/NCT06777342","phase":"Not applicable","title":"Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery","status":"not-yet-recruiting","sponsor":"Yan Fuxia","countries":[],"us_states":[]},{"nct":"NCT05541276","url":"https://clinicaltrials.gov/study/NCT05541276","phase":"Phase 3","title":"MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children","status":"recruiting","sponsor":"Arash Afshari","countries":["Denmark"],"us_states":[]},{"nct":"NCT06756828","url":"https://clinicaltrials.gov/study/NCT06756828","phase":"Not applicable","title":"Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spectrum","status":"not-yet-recruiting","sponsor":"Saint Vincent's Hospital, Korea","countries":[],"us_states":[]},{"nct":"NCT06768580","url":"https://clinicaltrials.gov/study/NCT06768580","phase":"Not applicable","title":"Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty","status":"recruiting","sponsor":"Tanta University","countries":["Egypt"],"us_states":[]}],"aliases":["Acetyl-5-methoxytryptamine"],"summary":"A hormone the body makes that helps set the sleep-wake cycle. It is sold over the counter as a dietary supplement, often as a sleep aid.","citations":[{"n":1,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list, updated May 2026"},{"n":2,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":3,"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances that may present significant safety risks"},{"n":4,"url":"https://www.fda.gov/media/193344/download","tier":"primary","type":"regulatory","title":"FDA briefing document for the Pharmacy Compounding Advisory Committee, July 2026"},{"n":5,"url":"https://www.fda.gov/food/dietary-supplements","tier":"primary","type":"regulatory","title":"FDA: dietary supplements"},{"n":6,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jacobs-pills-inc-534441-05312018","tier":"primary","type":"regulatory","title":"FDA warning letter to a compounding pharmacy that used melatonin, May 2018"},{"n":7,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nextl3vel-services-group-llc-dba-stuff-good-you-610446-12222020","tier":"primary","type":"regulatory","title":"FDA warning letter: a sleep syrup with melatonin, December 2020"},{"n":8,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dk-vitamins-566205-02052019","tier":"primary","type":"regulatory","title":"FDA warning letter: disease claims and a sublingual melatonin product, February 2019"},{"n":9,"url":"https://www.fda.gov/food/generally-recognized-safe-gras/post-market-determinations-use-substance-not-gras","tier":"primary","type":"regulatory","title":"FDA: post-market determinations that the use of a substance is not GRAS"},{"n":10,"url":"https://www.climatesolutionslaw.com/2025/07/chocolate-therapy-the-legal-limits-of-mood-and-sleep-claims-in-functional-foods/","tier":"legal-analysis","type":"legal-analysis","title":"Husch Blackwell: the legal limits of mood and sleep claims in functional foods"},{"n":11,"url":"https://pubmed.ncbi.nlm.nih.gov/23691095/","tier":"peer-reviewed","type":"systematic-review","title":"Meta-analysis: melatonin for the treatment of primary sleep disorders, 2013"},{"n":12,"url":"https://pubmed.ncbi.nlm.nih.gov/12076414/","tier":"peer-reviewed","type":"systematic-review","title":"Cochrane review: melatonin for the prevention and treatment of jet lag, 2002"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/29096777/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: prolonged-release melatonin for insomnia in children with autism, 2017"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/31722088/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review: adverse events of melatonin for sleep disorders, 2019"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/41481289/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review: melatonin use in young children, 2026"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/35653284/","tier":"peer-reviewed","type":"reference","title":"MMWR: pediatric melatonin ingestions, United States, 2012 to 2021"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/37097362/","tier":"peer-reviewed","type":"reference","title":"Study: quantity of melatonin and CBD in melatonin gummies sold in the US, 2023"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/27855744/","tier":"peer-reviewed","type":"reference","title":"Study: variability of melatonin content in supplements, 2017"},{"n":19,"url":"https://pubmed.ncbi.nlm.nih.gov/28770437/","tier":"peer-reviewed","type":"animal","title":"Mouse study: melatonin and caloric restriction in the hippocampus of aging mice, 2018"},{"n":20,"url":"https://clinicaltrials.gov/study/NCT03954899","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT03954899: melatonin, Alzheimer's markers and memory in older adults"},{"n":21,"url":"https://clinicaltrials.gov/study/NCT07542756","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT07542756: common insomnia medications, including melatonin"},{"n":22,"url":"https://clinicaltrials.gov/study/NCT06093477","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT06093477: melatonin for sleep in teens after major surgery"},{"n":23,"url":"https://abcnews.go.com/wellness/story/melatonin-makers-urged-follow-new-packaging-labeling-guidelines-109312431","tier":"established-news","type":"reference","title":"ABC News: melatonin makers urged to follow new packaging guidelines, April 2024"}],"known_risks":["Poison centers logged 260,435 melatonin swallowings by children and teens from 2012 to 2021. Five children needed a breathing machine, and two died [^16].","Labels may not match what is inside. In a 2017 study of supplements, the amount ranged from 83% less to 478% more than the label [^18].","The same study found serotonin in eight of the supplements it tested. Serotonin is a brain chemical [^18].","In trials, the most common harms were daytime sleepiness, headache and dizziness. Most were mild and went away [^14].","FDA says some studies raise concerns. They point to blood sugar, the heart, the eyes, the nerves and having children [^7].","Case reports suggest harm in people with seizures. People on warfarin, a blood thinner, may be at risk too [^12]."],"short_answer":"Melatonin is in Category 1: pharmacies may use it while FDA decides, which is not approval. Pills and gummies you swallow are sold as dietary supplements. The evidence grade is moderate-human: small gains in sleep. Reports of children swallowing it rose 530% from 2012 to 2021.","evidence_grade":"moderate-human","open_questions":["Long-term use is not well studied. Most trials lasted four weeks or less [^14].","No trials show if melatonin helps young children sleep when they have no other health problem [^15].","Nobody knows if melatonin helps memory or slows Alzheimer's disease. A trial in Iowa is testing it in older adults [^20].","Claims that it slows aging rest on animal studies. A study in mice measured brain genes, not lifespan [^19].","How closely products sold in the US match their labels is not settled. A 2023 study measured gummies sold in the US [^17].","FDA has not yet decided whether to add melatonin to the federal list for pharmacies [^1] [^2]."],"section_routes":"The legal ways to get melatonin are as a dietary supplement you swallow, from a pharmacy that compounds it, or in a clinical trial [^4] [^1] [^20].\n\nPills and gummies are sold over the counter as dietary supplements [^4] [^16]. FDA does not check them before they are sold [^5].\n\nA prescriber can order melatonin made by a pharmacy, because it is in Category 1 [^1] [^2]. That is not FDA approval [^2].\n\nTrials in Iowa, Pennsylvania and California are recruiting [^20] [^21] [^22]. The trials block on this page lists open trials with their dates.","status_by_route":[{"route":"Compounded by a pharmacy on a prescription","status":"category-1","source_url":"https://www.fda.gov/media/94155/download"},{"route":"Sold as a dietary supplement that is swallowed","status":"dietary-supplement","source_url":"https://www.fda.gov/media/193344/download"}],"regulatory_as_of":"2026-10-26","section_channels":"Most melatonin is sold lawfully as a supplement [^16]. Some products are sold outside the rules for supplements, foods or compounded drugs [^6] [^7] [^8].\n\nCompounding: in 2018, FDA warned a pharmacy that drugs it made with melatonin did not qualify under the compounding law [^6]. FDA also found serious problems in how it made drugs, which put patients at risk [^6].\n\nFoods: in 2020, FDA warned a seller of a sleep syrup with melatonin [^7]. FDA said melatonin is not approved for use in any conventional food [^7]. A law firm says the same holds for chocolates with melatonin [^10].\n\nDisease claims: in 2019, FDA warned an online seller that claimed melatonin protects the heart [^8]. FDA said those claims made it an unapproved drug [^8]. FDA also said the seller's under-the-tongue product was not a dietary supplement [^8].","section_evidence":"The evidence grade is moderate-human: many trials in people show small gains in sleep [^11] [^12].\n\nSleep: a 2013 meta-analysis pooled 19 trials with 1,683 people who had sleep disorders [^11]. People on melatonin fell asleep about 7 minutes sooner and slept about 8 minutes longer [^11]. The authors call the gains modest [^11].\n\nJet lag: a 2002 Cochrane review found 10 trials in travelers [^12]. In nine, melatonin reduced jet lag after flights across five or more time zones [^12].\n\nChildren with autism: a 2017 randomized trial tested a slow-release tablet made for children [^13]. After 13 weeks, 125 children and teens slept about 57 minutes longer on it, against 9 minutes on a dummy pill [^13]. A 2026 review found trials in young children only for those with conditions such as autism [^15].\n\nAnimals: a 2018 study in aging mice found melatonin changed some brain genes [^19]. That is a mouse result, not shown in people [^19].","regulatory_status":"category-1","section_what_it_is":"Melatonin is a hormone the body makes. It helps set the sleep and wake cycle [^16]. It is not a peptide. People use it for trouble sleeping and for jet lag [^12] [^16].\n\nIn the US, it is sold over the counter in many forms, including gummies [^16] [^17] [^18]. Some sleep syrups and chocolates add it too [^7] [^10].\n\nBeing made by the body does not make it risk-free. Products differ in how much they hold [^17] [^18].","section_is_it_legal":"Melatonin is in Category 1: FDA's list of substances pharmacies may use while FDA decides whether to add them to the federal list [^1] [^2]. That is not approval, and FDA is still deciding [^1] [^2]. Checked 26 October 2026.\n\nFor Category 1, FDA says it does not plan to act against a pharmacy that meets the policy's conditions [^2]. That is a choice not to act, not approval of melatonin as a drug [^2]. It is not in Category 2, FDA's list of substances that may present significant safety risks [^1] [^3]. In 2018, FDA warned a pharmacy that drugs made with melatonin did not qualify [^6]. FDA said then that melatonin was not part of any FDA-approved drug [^6]. FDA's May 2026 list now shows it in Category 1 [^1].\n\nPills and gummies you swallow fall under a different law. FDA calls melatonin a dietary supplement [^4]. FDA does not approve a dietary supplement before it is sold. The maker must check its safety and label [^5].\n\nThat status has limits. FDA says a product held under the tongue is not a dietary supplement, because a supplement must be swallowed [^8]. FDA also says melatonin is not approved for use in any conventional food, such as a syrup [^7] [^9].","unofficial_channels":[{"type":"compounding-outside-the-rules","what_it_is":"Pharmacies that compound melatonin drugs without meeting the conditions of the federal compounding law.","enforcement":[{"date":"2018-05-31","text":"FDA warning letter to a compounding pharmacy that made drugs with melatonin outside section 503A.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jacobs-pills-inc-534441-05312018"}],"legal_position":{"text":"FDA does not plan to act against compounding with a Category 1 substance when its policy's conditions are met. 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listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}