Melatonin Capsules

Overview of Melatonin Capsules

Dosage Strength

Immediate Release: 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 15 mg, 20 mg
Slow Release: 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 15 mg, 20 mg

General Information

Patients with sleep disorders can employ the neurohormone melatonin, also known as 5-methoxy-N-acetyltryptamine, to control their sleep-wake cycles. All species that display circadian or circannual rhythms have endogenous melatonin released by the pineal gland. The maintenance of sleep-wake rhythms is a known function of melatonin, and supplementation may assist to manage sleep abnormalities brought on by insomnia, jet lag, rotating shift work, depression, chronic renal disease, hospitalizations in intensive care units, and different neurological conditions. The function of melatonin in a number of neurologic, hormonal, gastrointestinal, and neoplastic illnesses is still being clarified by clinical research. When dark-skinned tadpoles fed a pineal gland extract were observed to have lighter skin, the effects of melatonin as a hormone were first discovered in 1917. In 1958, melatonin was extracted from the pineal gland. The majority of commercial melatonin products are made from 5-methoxyindole; occasionally, goods are made from animal (bovine) pineal glands. Due to the potential risk of contamination from infectious prions and viruses derived from animals, which may result in serious sickness, it is not advised to use melatonin products derived from animals. The Natural Health Products ingredients/monograph database for Health Canada lists oral melatonin. 1 Melatonin is only available by prescription in Europe under the brand name Circadin, which is promoted as a monotherapy for the short-term management of primary insomnia in patients 55 years of age or older and characterized by poor sleep quality. 2 Melatonin is regarded as an experimental medicine by the American Sleep Disorder Association, who do not advise using it unsupervised. Since 1993, the U.S. Food and Drug Administration (FDA) has designated melatonin as an orphan drug to treat non-24-hour sleep-wake disorder (non-24), a condition that develops when blind patients are unable to synchronize their circadian rhythms to a light-dark cycle and results in circadian rhythm sleep disorders. For the purpose of treating neonatal hypoxia ischemic encephalopathy, the FDA added melatonin to its list of orphan drugs in 2013. In the United States, melatonin is also offered as an over-the-counter drug in accordance with the Dietary Supplement and Health Education Act of 1994. (DSHEA).

NOTE: The Dietary Supplement and Health Education Act of 1994 governs the marketing of nutraceuticals in the United States (DSHEA). Since nutraceuticals are not regulated like drugs, scientific evidence to support any claimed benefit(s) may not always be available as it is for conventional pharmaceuticals. Additionally, consumers should be aware that the potency and purity of nutraceuticals can vary significantly, and strict quality control standards are not necessary for these products.


1.Health Canada Drugs and Health Products and Natural Health Products Ingredients Database. Melatonin Monograph. First published 2012. Modified May 13, 2013. Web. Accessed August 4, 2015. Available at:
2.Circadin (oral melatonin) European Medicines Agency official product label. Dublin 2, Republic of Ireland; Flynn Pharma Ltd: 2015 July.
3.Harpsoe NG, Andersen LP, Gogenur I, et a;. Clinical pharmacokinetics of melatonin: a systematic review. Eur J Clin Pharmacol. 2015;71:901-909.
4.Cardinali DP, Srinivasan V, Brzezinski A, et al. Melatonin and its analogs in insomnia and depression. J Pineal Res 2012;52:365-75.
5.Ferracioli-Oda E, Qawasmi A, Bloch MH. Meta-analysis: melatonin for the treatment of primary sleep disorders. 2013. PLoS ONE 8(5): e63773. doi:10.1371/journal.pone.0063773.
6.Wilson SJ, Nutt DJ, Alford C et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol 2010;24:1577–1601.
7.Quick Dissolve maximum strength 10 mg melatonin tablets. Nature’s Bounty. Bohemia, NY: 2014.
8.Dolberg OT, Hirschmann S, Grunhaus L. Melatonin for the treatment of sleep disturbances in major depressive disorder. Am J Psychiatry 1998;155:1119-21.
9.Chase JE, Gidal BE. Melatonin: therapeutic use in sleep disorders. Ann Pharmacother 1997;31:1218-26.
10.Sack RL, Brandes RW, Kendall AR, et al. Entrainment of free-running circadian rhythms by melatonin in blind people. N Engl J Med 2000;343:1070-1077.
11.Jorgensen KM, Witting MD. Does exogenous melatonin improve day sleep or night alertness in emergency physicians working night shifts? Ann Emerg Med 1998;31:699-704.
12.McArthur AJ, Budden SS. Sleep dysfunction in Rett Syndrome: a trial of exogenous melatonin treatment. Dev Med Child Neurol 1998;40:186-92.
13.Tunkel DE, Bauer CA, Sun GH, et al. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014;151(2 Suppl):S1-S40.
14.Megwalu UC, Finnell JE, Piccirillo JF. The effects of melatonin on tinnitus and sleep. Otolaryngol Head Neck Surg. 2006;134:210-213.
15.Rosenberg SI, Silverstein H, Rowan PT, et al. Effect of melatonin on tinnitus. Laryngoscope 1998;108:305-10.
16.Williamson BL, Tomlinson AJ, Mishra PK, et al: Structural characterization of contaminants found in commercial preparations of melatonin:similarities to case-related compounds from L-tryptophan associated with eosinophilia-myalgia syndrome. Chem
17.Naylor S, Gleich GJ. Over-the-counter melatonin products and contamination. Am Fam Physician. 1999;59:284, 287-8.
18.Norton SA. Raw animal tissues and dietary supplements. N Engl J Med 2000;343:304–305.
19.Rozerem (ramelteon) package insert. Lincolnshire, IL: Takeda Pharmaceuticals; 2010 Nov.
20.Waldron DL, Bramble D, Gringras P: Melatonin: Prescribing practices and adverse events. Arch Dis Child 2005;90(11):1206-1207.
21.Davis FC. Melatonin: role in development. J Biol Rhythms 1997;12:498-508.
22.Illnerova H, Buresova M, Presl J. Melatonin rhythm in human milk. J Clin Endocrinol Metab 1993;77:838—41.
23.Holliman BJ, Chyka PA. Problems in assessment of acute melatonin overdose. South Med J 1997;90:451-3.
24.Force RW, Hansen L, Bedell M. Psychotic episode after melatonin. Ann Pharmacother 1997;31:1408.
25.Hong YG, Riegler JL. Is melatonin associated with the development of autoimmune hepatitis? J Clin Gastroenterol 1997;25:376-8.
26.Fourman LT, Robert Meyer B. Autoimmune hepatitis in association with ramelteon. J Clin Gastroenterol. 2013 Apr 29. [Epub ahead of print]

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