# 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.

Status checked: 2026-10-26. Last verified: 2026-10-26. Primary source: https://www.fda.gov/media/94155/download

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Acetyl-5-methoxytryptamine | primary | 2026-10-26 | [source](https://clinicaltrials.gov/study/NCT07542756) |
| Class | non-peptide | peer-reviewed | 2026-10-26 | [source](https://pubmed.ncbi.nlm.nih.gov/35653284/) |
| Regulatory status | category-1 | primary | 2026-10-26 | [source](https://www.fda.gov/media/94155/download) |
| Status source read | 2026-10-26 | primary | 2026-10-26 | [source](https://www.fda.gov/media/94155/download) |
| Evidence grade | moderate-human | our assessment | 2026-10-26 | [source](https://peptideindex.ai/methodology#evidence-grade) |

## Name

Melatonin

Source: https://pubmed.ncbi.nlm.nih.gov/35653284/

## 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.

Source: https://pubmed.ncbi.nlm.nih.gov/35653284/

## 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.

Source: https://peptideindex.ai/methodology#short-answer

## Status by route

Source: https://www.fda.gov/media/94155/download

### Compounded by a pharmacy on a prescription

Status: category-1

Source: https://www.fda.gov/media/94155/download

### Sold as a dietary supplement that is swallowed

Status: dietary-supplement

Source: https://www.fda.gov/media/193344/download

## 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].

Source: https://pubmed.ncbi.nlm.nih.gov/35653284/

## 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].

Source: https://pubmed.ncbi.nlm.nih.gov/31722088/

## 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].

Source: https://pubmed.ncbi.nlm.nih.gov/35653284/

## 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].

Source: https://www.fda.gov/media/94155/download

## What the evidence shows

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].

Source: https://pubmed.ncbi.nlm.nih.gov/23691095/

## 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.

Source: https://www.fda.gov/media/94155/download

## 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].

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jacobs-pills-inc-534441-05312018

## Access routes

Source: https://www.fda.gov/media/94155/download

### 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: https://www.fda.gov/media/193344/download

### 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: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### 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: https://clinicaltrials.gov/study/NCT03954899

## Unofficial channels

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jacobs-pills-inc-534441-05312018

### Compounding outside the rules

What it is: Pharmacies that compound melatonin drugs without meeting the conditions of the federal compounding law.

Legal position: FDA 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. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

Documented risks:

- FDA found serious problems in how one such pharmacy made its drugs, which put patients at risk. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jacobs-pills-inc-534441-05312018)

Enforcement:

- 2018-05-31: FDA warning letter to a compounding pharmacy that made drugs with melatonin outside section 503A. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jacobs-pills-inc-534441-05312018)

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

## Recruiting trials

Snapshot date: 2026-10-26.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

- 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 none listed
- 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 none listed, us states none listed
- 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 none listed, us states none listed
- 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 none listed
- 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 none listed
- 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 none listed, us states none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed, us states none listed
- 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 none listed, us states none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed, us states none listed
- 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 none listed, us states none listed
- 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 none listed, us states none listed
- 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 none listed, us states none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed, us states none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed
- 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 none listed, us states none listed
- 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 none listed, us states none listed
- 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 none listed
- 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 none listed, us states none listed
- 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 none listed

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=AREA%5BInterventionName%5D%28melatonin%29+AND+NOT+AREA%5BInterventionName%5D%28ramelteon+OR+tasimelteon+OR+agomelatine%29&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://www.fda.gov/media/94155/download

### 1. FDA: 503A bulk drug substances category list, updated May 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/94155/download

### 2. FDA: bulk drug substances used in compounding under section 503A

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### 3. FDA: bulk drug substances that may present significant safety risks

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

### 4. FDA briefing document for the Pharmacy Compounding Advisory Committee, July 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/193344/download

### 5. FDA: dietary supplements

Type: regulatory

Tier: primary

Source: https://www.fda.gov/food/dietary-supplements

### 6. FDA warning letter to a compounding pharmacy that used melatonin, May 2018

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jacobs-pills-inc-534441-05312018

### 7. FDA warning letter: a sleep syrup with melatonin, December 2020

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nextl3vel-services-group-llc-dba-stuff-good-you-610446-12222020

### 8. FDA warning letter: disease claims and a sublingual melatonin product, February 2019

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dk-vitamins-566205-02052019

### 9. FDA: post-market determinations that the use of a substance is not GRAS

Type: regulatory

Tier: primary

Source: https://www.fda.gov/food/generally-recognized-safe-gras/post-market-determinations-use-substance-not-gras

### 10. Husch Blackwell: the legal limits of mood and sleep claims in functional foods

Type: legal-analysis

Tier: legal-analysis

Source: https://www.climatesolutionslaw.com/2025/07/chocolate-therapy-the-legal-limits-of-mood-and-sleep-claims-in-functional-foods/

### 11. Meta-analysis: melatonin for the treatment of primary sleep disorders, 2013

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/23691095/

### 12. Cochrane review: melatonin for the prevention and treatment of jet lag, 2002

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/12076414/

### 13. Randomized trial: prolonged-release melatonin for insomnia in children with autism, 2017

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/29096777/

### 14. Systematic review: adverse events of melatonin for sleep disorders, 2019

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/31722088/

### 15. Systematic review: melatonin use in young children, 2026

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/41481289/

### 16. MMWR: pediatric melatonin ingestions, United States, 2012 to 2021

Type: reference

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/35653284/

### 17. Study: quantity of melatonin and CBD in melatonin gummies sold in the US, 2023

Type: reference

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/37097362/

### 18. Study: variability of melatonin content in supplements, 2017

Type: reference

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/27855744/

### 19. Mouse study: melatonin and caloric restriction in the hippocampus of aging mice, 2018

Type: animal

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/28770437/

### 20. ClinicalTrials.gov NCT03954899: melatonin, Alzheimer's markers and memory in older adults

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT03954899

### 21. ClinicalTrials.gov NCT07542756: common insomnia medications, including melatonin

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT07542756

### 22. ClinicalTrials.gov NCT06093477: melatonin for sleep in teens after major surgery

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT06093477

### 23. ABC News: melatonin makers urged to follow new packaging guidelines, April 2024

Type: reference

Tier: established-news

Source: https://abcnews.go.com/wellness/story/melatonin-makers-urged-follow-new-packaging-labeling-guidelines-109312431

Last verified: 2026-10-26.

Sources:

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[^1]: FDA: 503A bulk drug substances category list, updated May 2026 https://www.fda.gov/media/94155/download
[^2]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[^3]: FDA: bulk drug substances that may present significant safety risks https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[^4]: FDA briefing document for the Pharmacy Compounding Advisory Committee, July 2026 https://www.fda.gov/media/193344/download
[^5]: FDA: dietary supplements https://www.fda.gov/food/dietary-supplements
[^6]: FDA warning letter to a compounding pharmacy that used melatonin, May 2018 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jacobs-pills-inc-534441-05312018
[^7]: FDA warning letter: a sleep syrup with melatonin, December 2020 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nextl3vel-services-group-llc-dba-stuff-good-you-610446-12222020
[^8]: FDA warning letter: disease claims and a sublingual melatonin product, February 2019 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dk-vitamins-566205-02052019
[^9]: FDA: post-market determinations that the use of a substance is not GRAS https://www.fda.gov/food/generally-recognized-safe-gras/post-market-determinations-use-substance-not-gras
[^10]: Husch Blackwell: the legal limits of mood and sleep claims in functional foods https://www.climatesolutionslaw.com/2025/07/chocolate-therapy-the-legal-limits-of-mood-and-sleep-claims-in-functional-foods/
[^11]: Meta-analysis: melatonin for the treatment of primary sleep disorders, 2013 https://pubmed.ncbi.nlm.nih.gov/23691095/
[^12]: Cochrane review: melatonin for the prevention and treatment of jet lag, 2002 https://pubmed.ncbi.nlm.nih.gov/12076414/
[^13]: Randomized trial: prolonged-release melatonin for insomnia in children with autism, 2017 https://pubmed.ncbi.nlm.nih.gov/29096777/
[^14]: Systematic review: adverse events of melatonin for sleep disorders, 2019 https://pubmed.ncbi.nlm.nih.gov/31722088/
[^15]: Systematic review: melatonin use in young children, 2026 https://pubmed.ncbi.nlm.nih.gov/41481289/
[^16]: MMWR: pediatric melatonin ingestions, United States, 2012 to 2021 https://pubmed.ncbi.nlm.nih.gov/35653284/
[^17]: Study: quantity of melatonin and CBD in melatonin gummies sold in the US, 2023 https://pubmed.ncbi.nlm.nih.gov/37097362/
[^18]: Study: variability of melatonin content in supplements, 2017 https://pubmed.ncbi.nlm.nih.gov/27855744/
[^19]: Mouse study: melatonin and caloric restriction in the hippocampus of aging mice, 2018 https://pubmed.ncbi.nlm.nih.gov/28770437/
[^20]: ClinicalTrials.gov NCT03954899: melatonin, Alzheimer's markers and memory in older adults https://clinicaltrials.gov/study/NCT03954899
[^21]: ClinicalTrials.gov NCT07542756: common insomnia medications, including melatonin https://clinicaltrials.gov/study/NCT07542756
[^22]: ClinicalTrials.gov NCT06093477: melatonin for sleep in teens after major surgery https://clinicaltrials.gov/study/NCT06093477