{"slug":"melatonin","seoKey":"melatonin","inn":"melatonin","displayName":"Melatonin","codes":["N05CH01"],"synonyms":["N-acetyl-5-methoxytryptamine","5-methoxy-N-acetyltryptamine","N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide","melatonine","melatoninum","NSC 113928","NSC 56423","aMT"],"legalClass":"rx","identifiers":{"cas":"73-31-4","pubchemCid":896,"unii":"JL5DK93RCL","inchikey":"DRLFMBDRBRZALE-UHFFFAOYSA-N","wikidataQid":"Q180912","formula":"C13H16N2O2","molecularWeight":232.28},"approvals":[{"market":"US","status":"not_approved","note":"No approved medicine. The substance is sold as a dietary supplement under the Dietary Supplement Health and Education Act, without an approval procedure and without an efficacy review. Verified negative finding with a control query: the approved-drugs database returned a literal not-found response on 2026-09-20, while the same endpoint returned a hit for a control substance in the same moment. A label endpoint does return entries, but all of them are unapproved homeopathic over-the-counter products in which the substance is declared as an ingredient; a registered label is not an approval. In conventional foods, as opposed to supplements, the substance is not permitted: the agency stated in 2011 that no food additive regulation authorises its use and that there is no basis for treating it as generally recognised as safe in foods.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22melatonin%22"},{"market":"EU","status":"approved_rx","date":"2007-06-29","note":"Approved centrally and prescription-only, in two separate authorisations. The first, dated 2007-06-29 under EMEA/H/C/000695, covers a prolonged-release tablet for the short-term treatment of primary insomnia in patients aged 55 or over. The second, dated 2018-09-20 under EMEA/H/C/004425, covers prolonged-release tablets for children and adolescents aged 2 to 18 with autism spectrum disorder or neurogenetic conditions, and, after a later extension, for children and adolescents aged 6 to 17 with attention deficit hyperactivity disorder, in both cases only where sleep hygiene measures have been insufficient. Both are expressly subject to medical prescription. A parallel food-law track exists: two health claims for the substance are authorised under Regulation (EU) No 432/2012, but a claim says nothing about whether a given product may be sold as a food, which each member state decides case by case.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/circadin"},{"market":"DE","status":"approved_rx","note":"Prescription-only for the finished medicines: both centrally authorised products are marketable in Germany by virtue of the EU authorisation. Beyond them the classification is contested. The federal institutes have held since a joint assessment of 1996-06-16, which the risk assessment institute still publishes as its position, that the substance is pharmacologically active and not a food or food supplement, expressly irrespective of the amount, down to a tenth of a milligram. Practice has diverged: supplement products carrying the authorised health-claim amounts are in fact sold and merely notified to the food authority. That authority itself calls the classification a highly contested question. A test case before an administrative court over a three-milligram product ended on 2018-04-25 when the action was withdrawn, so no decision on the merits, no ruling by a higher court and no binding maximum amount exists to this day.","source":"https://www.bfr.bund.de/de/a-z_index/melatonin-5061.html"},{"market":"UK","status":"approved_rx","note":"Approved and prescription-only; positive finding with a licence number. The prolonged-release 2 mg tablet holds PLGB 52348/0002 with the legal category stated verbatim as prescription only medicine, indicated as monotherapy for the short-term treatment of primary insomnia in patients aged 55 or over. A product search returned 40 entries for the substance on 2026-09-20, held by a dozen different companies and including tablets, prolonged-release tablets and an oral solution; one of them is the first product licensed in this market for children with sleep problems arising from attention deficit hyperactivity disorder. Sale as a food supplement is not permitted here.","source":"https://www.medicines.org.uk/emc/search?q=melatonin"},{"market":"AU","status":"approved_rx","note":"Prescription-only as the rule, under schedule 4 of the poisons standard, with one narrow exception: since June 2021 a prolonged-release form in small packs is a pharmacist-only medicine under schedule 3 for people over 55 with primary insomnia. Every other form, in particular preparations for children and higher strengths, remains prescription-only. The substance is expressly not a freely sold supplement here. IMPORTANT CAVEAT: the wording of the schedule 3, schedule 4 and appendix H entries could NOT be verified against the primary instrument. The regulator's site and the legislation register were unreachable from the working environment on 2026-09-20 in three attempts, returning timeouts or HTTP 000. The classification above therefore rests on a peer-reviewed publication describing the down-scheduling, not on a register extract, and the pack-size and strength figures that circulate in search summaries are deliberately not reproduced.","source":"https://pubmed.ncbi.nlm.nih.gov/37354280/"},{"market":"CA","status":"approved_rx","date":"2026-07-16","note":"Two tracks at once, both documented. Since 2026-07-16 a prescription medicine exists: prolonged-release tablets in two strengths, drug identification numbers 02560798 and 02560801, listed in the drug product database as human, prescription and marketed. The database query was verified with a control substance that returned hits in the same moment. The only other human-relevant entry is a veterinary implant marketed since 1988. In parallel, the substance is freely available as a licensed natural health product under a product number; an automated query of that separate database failed in the working environment, so this part is recorded as a status statement without a count.","source":"https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106382"},{"market":"CH","status":"approved_rx","note":"Approved and prescription-only in dispensing category B, meaning supply in pharmacies only against a medical prescription. The authorised product is a 2 mg prolonged-release tablet for primary insomnia as monotherapy from the age of 55, ATC code N05CH01. Sale as a food or food supplement is not permitted. The regulator warned expressly on 2023-11-27 against private imports advertised by foreign online shops, stating that the substance is prescription-only here because of its pharmacological action; private individuals may import at most a month's supply for personal use.","source":"https://compendium.ch/product/1237871-circadin-ret-tabl-2-mg"}],"devStage":"approved","strongestEvidence":"meta_analysis","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT01906866","name":"Registration trial for the paediatric prolonged-release product (autism spectrum disorder and neurogenetic conditions)","phase":"Phase 3","n":125,"status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q180912","https://pubchem.ncbi.nlm.nih.gov/compound/896"],"lastVerified":"2026-09-20","version":"1.0","published":true,"locale":"en","title":"Melatonin: what the trials show, status and safety","summary":"Melatonin is not a peptide but a small hormone the pineal gland makes at night. Its legal status splits sharply by market: a prescription medicine in the European Union, the United Kingdom, Switzerland and Canada, and a freely sold supplement in the United States, where no melatonin drug has ever been approved. The trial evidence is thinner than the reputation suggests. In primary sleep problems it brought sleep on about seven minutes sooner than placebo, in secondary ones it did nothing measurable, and an American sleep-medicine guideline advises clinicians against using it for chronic insomnia.","updated":"2026-09-20","url":"https://mypep.app/peptides/melatonin"}