Melatonin is a naturally occurringhormone produced in the brain that is also used as a dietary supplement and medication.[9][12] As a hormone, melatonin is released by the pineal gland and is involved in sleep–wake cycles.[9][12] As a supplement, it is often used for the attempted short-term treatment of disrupted sleep patterns, such as from jet lag or shift work, and is typically taken orally.[13][14][15] There is evidence of its benefit for this use, but is not strong.[16] A 2017 review found that sleep onset occurred six minutes faster with use, but found no change in total time asleep.[14]
Melatonin was discovered in 1958.[9] It is sold over-the-counter in Canada and the United States;[17][19] in the United Kingdom, it is a prescription-only medication.[15] In Australia and the European Union, it is indicated for difficulty sleeping in people over the age of 54.[23][8] In the European Union, it is indicated for the treatment of insomnia in children and adolescents.[18] The U.S. Food and Drug Administration (FDA) treats melatonin as a dietary supplement and, as such, has not approved it for any medical uses.[17] It was approved for medical use in the European Union in 2007.[8] Besides melatonin, certain syntheticmelatonin receptor agonists like ramelteon, tasimelteon, and agomelatine are also used in medicine.[24][25] In 2021, it was the 257th most commonly prescribed medication in the United States, with more than one million prescriptions.[26][27]
^Buscemi N, Vandermeer B, Pandya R, Hooton N, Tjosvold L, Hartling L, et al. (November 2004). "Melatonin for treatment of sleep disorders"(PDF). Evidence Report/Technology Assessment No. 108. (Prepared by the University of Alberta Evidence-based Practice Center, Under Contract No. 290-02-0023.) AHRQ Publication No. 05-E002-2. Rockville, MD: Agency for Healthcare Research and Quality (108). Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services: 1–7. doi:10.1037/e439412005-001. PMC4781368. PMID15635761. Retrieved 5 June 2013.
^ abMatheson E, Hainer BL (July 2017). "Insomnia: Pharmacologic Therapy". American Family Physician. 96 (1): 29–35. PMID28671376.
^ abcBritish national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 482–483. ISBN978-0-85711-338-2.
^Brasure M, MacDonald R, Fuchs E, Olson CM, Carlyle M, Diem S, et al. (2015). "Management of Insomnia Disorder[Internet]". AHRQ Comparative Effectiveness Reviews. 15 (16): EHC027–EF. PMID26844312. Evidence for benzodiazepine hypnotics, melatonin agonists in the general adult population, and most pharmacologic interventions in older adults was generally insufficient
^ ab"Slenyto EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 31 May 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized, provided the source is acknowledged.
^Cite error: The named reference drugbank was invoked but never defined (see the help page).
^"Australian Public Assessment Report for Melatonin"(PDF). Australian Government Department of Health and Ageing Therapeutic Goods Administration. January 2011. pp. 2, 4. Retrieved 9 January 2019. Monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.