Melatonin
Melatonin receptor agonistsHormone Receptor AgonistsIncreased Melatonin ActivityUS-FDASourced from openFDA
GET
/api/v1/drug/melatoninMechanism of action
Sourced from openFDAMechanism-of-action class: Hormone Receptor Agonists.
Hormone Receptor
Indications
Sourced from openFDA- USES: • For the temporary relief of symptoms including: • difficulty sleeping • jet lag These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Dosage & administration
Sourced from openFDADIRECTIONS: 1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.
Warnings & precautions
Sourced from openFDAIf pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
53,113 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Fatigue4,3538.2%
- 2Nausea3,6846.9%
- 3Off Label Use3,3426.3%
- 4Drug Ineffective3,1605.9%
- 5Diarrhoea2,9605.6%
- 6Headache2,8995.5%
- 7Dyspnoea2,5224.7%
- 8Insomnia2,4874.7%
- 9Fall2,3864.5%
- 10Pain2,3184.4%
- 11Dizziness2,2994.3%
- 12Vomiting2,1724.1%
- 13Death2,1144.0%
- 14Asthenia1,8943.6%
- 15Somnolence1,8933.6%
Literature
Recent PubMed references pinned to Melatonin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Circadian-Related Serotonin/Melatonin Level Modulates Cisplatin Ototoxicity Susceptibility Depended on NOS3-NO Pathway.Journal of pineal research · 2026 · Qiu S, Cai S, Xie R, et al.PMID 42262169DOI 10.1111/jpi.70154
- Host genetic regulation of rumen 6-hydroxymelatonin reduces methane emissions in dairy cattle.Proceedings of the National Academy of Sciences of the United States of America · 2026 · Zhang C, Liu Y, Wang G, et al.PMID 42258707DOI 10.1073/pnas.2604454123
- Melatonin to Induce Natural Sleep During Multiple-Breath Washout in Infants and Toddlers With Cystic Fibrosis.Pediatric pulmonology · 2026 · Jouret N, Verhulst S, Van Hoorenbeeck K, et al.PMID 42252928DOI 10.1002/ppul.71688
- Preventive Antiarrhythmic Properties of Melatonin in Experimental Diabetic Cardiomyopathy in Rats.Journal of pineal research · 2026 · Ovechkin AO, Gonotkov MA, Abramochkina AS, et al.PMID 42237712DOI 10.1111/jpi.70153
- Melatonin Accelerates Diabetic Wound Repair via Modulation of Tenascin C and Interleukin-10 in Fibroblasts.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026 · Sun J, Qian Y, Chen S, et al.PMID 42233548DOI 10.1096/fj.202600440RR
- Effect of NSAIDs, melatonin, vitamin D and vitamin B12 chronotherapy on postoperative recovery after third molar surgical extraction: A pilot randomized crossover placebo-controlled trial.Oral and maxillofacial surgery · 2026 · Abusamak M, Pérez-González F, Ruiz LV, et al.PMID 42230417DOI 10.1007/s10006-026-01582-0
- Melatonin-mediated regulation of fruit quality and physicochemical attributes: current advances and future perspectives.Biodegradation · 2026 · El-Beltagi HS, Du H, Khedr N, et al.PMID 42228182DOI 10.1007/s10532-026-10314-w
- Melatonin Alleviates Sleep Disturbance-Induced Ovarian Reserve Decline by Suppressing NLRP3-Mediated Pyroptosis in Granulosa Cells.Journal of pineal research · 2026 · Fang Q, Qiao Z, Li F, et al.PMID 42216928DOI 10.1111/jpi.70151
Clinical trials
The 10 most recently updated of 696 ClinicalTrials.gov registrations naming Melatonin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Impact of Cocaine Use and Withdrawal on SleepRecruiting · Observational · 32 enrolled · Hôpital le VinatierNCT07119567updated 2026-06-11
- The Basel BOMP-AID Randomized TrialRecruiting · Phase 4 · Interventional · 190 enrolled · University Hospital, Basel, SwitzerlandNCT03438526updated 2026-06-11
- Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular HemorrhageRecruiting · Phase 1 · Interventional · 60 enrolled · Johns Hopkins UniversityNCT05617833updated 2026-06-10
- Effects of Hydrocortisone, Melatonin, and Placebo on Jet LagCompleted · Phase 2 · Interventional · 57 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NCT00097474updated 2026-06-08
- A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for InsomniaRecruiting · Phase 4 · Interventional · 1,200 enrolled · University of PennsylvaniaNCT07542756updated 2026-06-05
- The Goodnight Screen Media StudyCompleted · Interventional · 170 enrolled · Baylor College of MedicineNCT05820555updated 2026-06-05
- Type 1 Diabetes REst for Metabolic HealthRecruiting · Interventional · 50 enrolled · University of Colorado, DenverNCT06627504updated 2026-06-03
- RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)Completed · Phase 2 · Interventional · 470 enrolled · Duke UniversityNCT06404112updated 2026-06-03
- Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use DisorderRecruiting · Observational · 20 enrolled · Spark Biomedical, Inc.NCT06487533updated 2026-06-02
- Melatonin and Solifenacin for Double-J Ureteral Stent SymptomsRecruiting · Phase 2 · Interventional · 189 enrolled · Beni-Suef UniversityNCT07617922updated 2026-06-02
Frequently asked questions
- How does Melatonin work?
- Mechanism-of-action class: Hormone Receptor Agonists.
- What is Melatonin used for?
- According to FDA labeling, Melatonin carries indications including: USES: • For the temporary relief of symptoms including: • difficulty sleeping • jet lag These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Melatonin?
- Melatonin is classified as Melatonin receptor agonists, Hormone Receptor Agonists, Increased Melatonin Activity.
- What are the brand names for Melatonin?
- Melatonin is marketed under brand names including Melatonex, Restone, Somnicin.
Note. Data for
melatonin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.