Non-peptide
Melatonin
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.
This page has not been individually reviewed by a clinician.
Fact sheet · 5 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Acetyl-5-methoxytryptamine | primary | clinicaltrials.gov | |
| Class | non-peptide | peer-reviewed | pubmed.ncbi.nlm.nih.gov | |
| Regulatory status | category-1 | primary | fda.gov | |
| Status source read | 2026-10-26 | primary | fda.gov | |
| Evidence grade | moderate-human | our assessment | peptideindex.ai |
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.
Our assessment, drawn from the sources below.
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].
In 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].
Being made by the body does not make it risk-free. Products differ in how much they hold [17] [18].
Where it stands legally
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.
For 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].
Pills 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].
That 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].
What the evidence shows
Evidence grade: moderate-human · our assessment
The evidence grade is moderate-human: many trials in people show small gains in sleep [11] [12].
Sleep: 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].
Jet 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].
Children 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].
Animals: a 2018 study in aging mice found melatonin changed some brain genes [19]. That is a mouse result, not shown in people [19].
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].
What nobody knows yet
- 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].
Legitimate ways to get it
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].
Pills and gummies are sold over the counter as dietary supplements [4] [16]. FDA does not check them before they are sold [5].
A prescriber can order melatonin made by a pharmacy, because it is in Category 1 [1] [2]. That is not FDA approval [2].
Trials in Iowa, Pennsylvania and California are recruiting [20] [21] [22]. The trials block on this page lists open trials with their dates.
Dietary supplement
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.
Lawful compounding
A pharmacy may compound melatonin on a prescription because it is in Category 1. A compounded product is not FDA-approved.
Clinical trial
A trial in Iowa is recruiting older adults to test melatonin on memory and Alzheimer's markers. The trials block lists open trials.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT07418554
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
Phase: Phase 3 · Sponsor: University Hospital, Strasbourg, France · Status: Not yet recruiting
Countries: France
US states: none listed
NCT07334197
Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy
Phase: Not applicable · Sponsor: Tanta University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07842900
Oral Melatonin as Adjunctive Therapy in Adults With Atopic Dermatitis
Phase: Not applicable · Sponsor: Can Tho University of Medicine and Pharmacy · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07651514
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Phase: Not applicable · Sponsor: StudySetGo · Status: Recruiting
Countries: United States
US states: Alabama, Arkansas, Florida, Georgia, North Carolina, South Carolina, Tennessee
NCT07863232
Melatonin and Immunonutrition for Pain Relief in Fibromyalgia
Phase: Not applicable · Sponsor: University of Thessaly · Status: Recruiting
Countries: Greece
US states: none listed
NCT07813936
Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis
Phase: Not applicable · Sponsor: Alexandria University · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07691996
Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU
Phase: Phase 4 · Sponsor: Rutgers, The State University of New Jersey · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07576764
Pediatric Prolonged-Release Melatonin for Sleep Disturbances in Children and Adolescents With Anorexia Nervosa (MELSom-ANOREXIA)
Phase: Phase 3 · Sponsor: Assistance Publique Hopitaux De Marseille · Status: Not yet recruiting
Countries: France
US states: none listed
NCT07732725
Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty
Phase: Early phase 1 · Sponsor: Benha University · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07695246
Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia
Phase: Not applicable · Sponsor: The University of Hong Kong · Status: Recruiting
Countries: Hong Kong
US states: none listed
NCT07721324
Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients
Phase: Phase 2/Phase 3 · Sponsor: Ain Shams University · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT06489327
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
Phase: Not applicable · Sponsor: Al-Azhar University · Status: Recruiting
Countries: Egypt, Iraq
US states: none listed
NCT07652801
COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHLOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE
Phase: Phase 3 · Sponsor: University of Child Health Sciences and Children's Hospital, Lahore · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07221968
Melatonin for the Treatment of DEE-SWAS
Phase: Phase 2 · Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07336277
Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
Phase: Phase 3 · Sponsor: Emory University · Status: Recruiting
Countries: United States
US states: Georgia
NCT07472075
Melatonin Versus Placebo for Bipolar Disorder
Phase: Phase 2 · Sponsor: Lars Vedel Kessing · Status: Recruiting
Countries: Denmark
US states: none listed
NCT07617922
Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
Phase: Phase 2 · Sponsor: Beni-Suef University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07553143
Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy
Phase: Not applicable · Sponsor: Armed Forces Medical Institute Bangladesh · Status: Recruiting
Countries: Bangladesh
US states: none listed
NCT07542756
A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
Phase: Phase 4 · Sponsor: University of Pennsylvania · Status: Recruiting
Countries: United States
US states: Pennsylvania
NCT07503600
The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections
Phase: Phase 3 · Sponsor: Ain Shams University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07495605
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.
Phase: Not applicable · Sponsor: Cairo University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07336095
Melatonin vs Midazolam in Children Undergoing Tonsillectomy
Phase: Phase 3 · Sponsor: Ain Shams University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07369284
Melatonin for Glycemic Control in Gestational Diabetes Mellitus
Phase: Phase 2 · Sponsor: Obstetrics & Gynecology Hospital of Fudan University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07120880
Efficacy of Chronotherapeutic Combination for Major Depressive Episode With Insomnia
Phase: Phase 3 · Sponsor: Assistance Publique - Hôpitaux de Paris · Status: Recruiting
Countries: France
US states: none listed
NCT07344467
Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery
Phase: Not applicable · Sponsor: Tanta University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07375342
Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
Phase: Not applicable · Sponsor: Benha University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07869030
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Phase: Not applicable · Sponsor: Future University in Egypt · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07554716
Chronobiology and Enteral Nutrition
Phase: Not applicable · Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Status: Recruiting
Countries: Spain
US states: none listed
NCT07096635
Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction
Phase: Not applicable · Sponsor: Assiut University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07036367
The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
Phase: Phase 4 · Sponsor: Al-Azhar University · Status: Recruiting
Countries: Egypt, Iraq
US states: none listed
NCT07046429
Affect of Melatonin on Sleep and Cognition in Cirrhosis
Phase: Not applicable · Sponsor: Weill Medical College of Cornell University · Status: Recruiting
Countries: United States
US states: New York
NCT07036796
Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
Phase: Phase 2 · Sponsor: Ain Shams University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07067307
Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Phase: Phase 1/Phase 2 · Sponsor: Mansoura University · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT06802913
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study
Phase: Early phase 1 · Sponsor: Woolcock Institute of Medical Research · Status: Recruiting
Countries: Australia
US states: none listed
NCT07345715
Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy
Phase: Not applicable · Sponsor: Tanta University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07850934
Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
Phase: Not applicable · Sponsor: Ain Shams University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07003243
Effectiveness of Topical Application of Melatonin On Bone Density and Implant Stability In Immediate Implantation
Phase: Phase 1 · Sponsor: University of Baghdad · Status: Not yet recruiting
Countries: Iraq
US states: none listed
NCT06826755
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
Phase: Not applicable · Sponsor: Mayo Clinic · Status: Recruiting
Countries: United States
US states: Minnesota
NCT06996171
Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia
Phase: Not applicable · Sponsor: CMH Kharian Medical College · Status: Recruiting
Countries: Pakistan
US states: none listed
NCT06949904
The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia
Phase: Phase 1/Phase 2 · Sponsor: Mian Muhammad Hassan Ahmed · Status: Recruiting
Countries: Pakistan
US states: none listed
NCT06935292
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
Phase: Phase 2/Phase 3 · Sponsor: Tanta University · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07737665
Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission
Phase: Phase 4 · Sponsor: Mahidol University · Status: Recruiting
Countries: Thailand
US states: none listed
NCT07307677
Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin
Phase: Not applicable · Sponsor: Mst.Sumyara Khatun · Status: Recruiting
Countries: Bangladesh
US states: none listed
NCT06768749
The Impact of Melatonin Lotion on Sleep and Mental Health
Phase: Not applicable · Sponsor: University of Redlands · Status: Recruiting
Countries: United States
US states: California
NCT06846086
Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy
Phase: Phase 3 · Sponsor: Tanta University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT06809751
Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy
Phase: Phase 2/Phase 3 · Sponsor: Mohsen Pourazizi · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT06777342
Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery
Phase: Not applicable · Sponsor: Yan Fuxia · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT05541276
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Phase: Phase 3 · Sponsor: Arash Afshari · Status: Recruiting
Countries: Denmark
US states: none listed
NCT06756828
Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spectrum
Phase: Not applicable · Sponsor: Saint Vincent's Hospital, Korea · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT06768580
Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty
Phase: Not applicable · Sponsor: Tanta University · Status: Recruiting
Countries: Egypt
US states: none listed
How people are getting it anyway
This section describes what happens and is not a recommendation.
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].
Compounding: 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].
Foods: 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].
Disease 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].
Compounding outside the rules
Pharmacies that compound melatonin drugs without meeting the conditions of the federal compounding law.
The lawFDA does not plan to act against compounding with a Category 1 substance when its policy's conditions are met. Compounding that misses those conditions gets no such promise.fda.gov
Documented riskFDA found serious problems in how one such pharmacy made its drugs, which put patients at risk.fda.gov
Enforcement FDA warning letter to a compounding pharmacy that made drugs with melatonin outside section 503A.fda.gov
Sources
- [1]FDA: 503A bulk drug substances category list, updated May 2026Regulatory · primary
- [2]FDA: bulk drug substances used in compounding under section 503ARegulatory · primary
- [3]FDA: bulk drug substances that may present significant safety risksRegulatory · primary
- [4]FDA briefing document for the Pharmacy Compounding Advisory Committee, July 2026Regulatory · primary
- [5]FDA: dietary supplementsRegulatory · primary
- [6]FDA warning letter to a compounding pharmacy that used melatonin, May 2018Regulatory · primary
- [7]FDA warning letter: a sleep syrup with melatonin, December 2020Regulatory · primary
- [8]FDA warning letter: disease claims and a sublingual melatonin product, February 2019Regulatory · primary
- [9]FDA: post-market determinations that the use of a substance is not GRASRegulatory · primary
- [10]Husch Blackwell: the legal limits of mood and sleep claims in functional foodsLegal analysis · legal-analysis
- [11]Meta-analysis: melatonin for the treatment of primary sleep disorders, 2013Systematic review · peer-reviewed
- [12]Cochrane review: melatonin for the prevention and treatment of jet lag, 2002Systematic review · peer-reviewed
- [13]Randomized trial: prolonged-release melatonin for insomnia in children with autism, 2017Rct · peer-reviewed
- [14]Systematic review: adverse events of melatonin for sleep disorders, 2019Systematic review · peer-reviewed
- [15]Systematic review: melatonin use in young children, 2026Systematic review · peer-reviewed
- [16]MMWR: pediatric melatonin ingestions, United States, 2012 to 2021Reference · peer-reviewed
- [17]Study: quantity of melatonin and CBD in melatonin gummies sold in the US, 2023Reference · peer-reviewed
- [18]Study: variability of melatonin content in supplements, 2017Reference · peer-reviewed
- [19]Mouse study: melatonin and caloric restriction in the hippocampus of aging mice, 2018Animal · peer-reviewed
- [20]ClinicalTrials.gov NCT03954899: melatonin, Alzheimer's markers and memory in older adultsReference · primary
- [21]ClinicalTrials.gov NCT07542756: common insomnia medications, including melatoninReference · primary
- [22]ClinicalTrials.gov NCT06093477: melatonin for sleep in teens after major surgeryReference · primary
- [23]ABC News: melatonin makers urged to follow new packaging guidelines, April 2024Reference · established-news
Last verified · 5 facts · 9 sources
- clinicaltrials.gov
- clinicaltrials.gov
- peptideindex.ai
- peptideindex.ai
- pubmed.ncbi.nlm.nih.gov
- pubmed.ncbi.nlm.nih.gov
- pubmed.ncbi.nlm.nih.gov
- fda.gov
- fda.gov
Primary source: https://www.fda.gov/media/94155/download
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
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