Melatonin
Also called N-acetyl-5-methoxytryptamine. Hormone (pineal hormone).
Bottom line
Melatonin is a hormone the brain makes to help control sleep/wake cycles [25]. In trials mostly in healthy volunteers or people with sleep complaints, supplements shortened the time to fall asleep by about 4 minutes [1], and most travel trials found less jet lag [7][8]. Product labels are often inaccurate [20], and Australia limits supply to pharmacists or prescription [28].
- In a 2005 meta-analysis of 17 small studies (284 people, mostly healthy volunteers or people with sleep complaints), melatonin shortened the time to fall asleep by 4.0 minutes and added 12.8 minutes of sleep [1].
- A Cochrane review found 9 of 10 trials in air travelers reported less jet lag with melatonin taken near the target bedtime, but a trial of 257 travelers found no effect [7][8].
- In a systematic review of 37 trials in people with sleep disorders, mostly 4 weeks or less, the most common reported side effect was daytime sleepiness, and no life-threatening adverse events were found [14].
- Laboratory tests found melatonin content ranging from -83% to +478% of the label in one set of supplements and from 0% to 667% in children's products [20][21].
- Melatonin is sold as a dietary supplement in the US, while Australia limits it to pharmacist-only or prescription supply [25][28].
New to Melatonin? Start with What is melatonin? A plain-English guide.
Evidence by outcome
| Outcome | Grade | Basis | Modifiers | Rationale |
|---|---|---|---|---|
| Jet lag symptoms | B Moderate | >=2 RCTs with mostly consistent results (B); not A because a 257-person trial found no effect | Subjective outcome onlyShort-term only | Why B grade for Jet lag symptoms: explainedApproved of the Jet lag symptoms grade |
| Sleep latency | C Limited | Pooled estimates mix healthy and clinical (insomnia) populations with no healthy-only estimate; direction not consistent across meta-analyses | Why C grade for Sleep latency: explainedApproved of the Sleep latency grade | |
| Sleep quality | C Limited | Results only in clinical populations being extrapolated to healthy adults (C) | Subjective outcome only | Why C grade for Sleep quality: explainedApproved of the Sleep quality grade |
| Total sleep time | C Limited | Pooled estimates mix healthy and clinical (insomnia) populations with no healthy-only estimate, and the healthy-adult trials are one single-dose crossover and one older-only trial | Short-term only | Why C grade for Total sleep time: explainedApproved of the Total sleep time grade |
Grades describe evidence for each outcome, not a recommendation. Open a grade for its rationale and dated grade history. How we grade
Several findings below come from people with diagnosed sleep problems, travelers or shift workers rather than healthy adults sleeping normally, and each section names the population. The evidence grading method explains what each grade requires.
Does melatonin help you fall asleep faster?
Slightly, on average [1]. A 2005 meta-analysis (a study that pools results from many trials) combined 17 studies with 284 participants and found melatonin shortened sleep onset latency, the time to fall asleep, by 4.0 minutes compared with placebo [1]. In the 15 studies that enrolled healthy people or people whose only condition was insomnia, the figure was 3.9 minutes [1]. The authors note the studies were highly heterogeneous in who they enrolled, how they measured sleep and the doses used [1].
Larger effects appear in clinical populations [2][5]. A meta-analysis of 19 placebo-controlled trials with 1,683 adults and children diagnosed with primary sleep disorders found melatonin reduced the time to fall asleep by 7.06 minutes [2]; that work was partly funded by Eli Lilly research awards to one author [2]. In adults diagnosed with insomnia disorder, a clinical population, a 2023 meta-analysis of 22 studies of melatonin and ramelteon found prolonged-release melatonin shortened self-rated sleep onset by 6.30 minutes and measured sleep onset by 5.05 minutes [5]. Results in clinical groups may not apply to healthy adults.
Dose and timing seem to matter [3]. A 2024 dose-response meta-analysis of 26 double-blind randomized controlled trials in people with insomnia and healthy volunteers found melatonin gradually reduced sleep onset latency, with the effect peaking at 4 mg/day [3]. Having insomnia, and the time between the dose and the sleep period, both predicted the size of the effect [3].
Evidence is mixed, and results differ by population [4][9][24]. A 2022 meta-analysis of 24 trials in chronic insomnia found melatonin was not significantly effective on sleep onset latency, total sleep time or sleep efficiency in adults [4]. A 2006 meta-analysis of 9 trials with 427 participants whose sleep was restricted, as in jet lag and shift work, found no clear evidence of an effect on the time to fall asleep [9]. A 2014 rapid evidence assessment of 35 randomized trials made weak recommendations for melatonin to help start sleep and for jet lag phase shifts [24].
Does melatonin increase total sleep time?
Modestly, in most analyses [1][2]. The 2005 meta-analysis found melatonin increased total sleep by 12.8 minutes compared with placebo, and by 13.7 minutes in the studies of healthy people or people with insomnia only [1]. In diagnosed primary sleep disorders, total sleep rose by 8.25 minutes, and longer trials using higher doses showed larger effects [2]. Those effects were modest but did not appear to fade with continued use [2].
Small trials in healthy adults point the same way [11][12]. In a double-blind crossover trial of 15 healthy middle-aged volunteers, a single 1.0 mg evening dose increased actual sleep time and sleep efficiency compared with placebo [11]. In a lab study that scheduled sleep at different times of the body clock, 5 mg taken 30 minutes before lights out raised sleep efficiency in 24 healthy adults over 55 during both biological day and night, while 0.3 mg showed only a trend that came from daytime sleep [12]. The authors of that trial note that in young adults melatonin increases sleep duration only when given during the day, when the body's own levels are low [12].
Shift workers are a separate case. A Cochrane review of 15 placebo-controlled trials in 718 shift workers, nine of them on melatonin, found that 1-10 mg of melatonin after a night shift may add about 24 minutes of daytime sleep (seven trials, 263 participants) and 17 minutes of night-time sleep (three trials, 234 participants), both rated low-quality evidence [10]. It found no dose-response effect, and the time to fall asleep may be similar to placebo (low-quality evidence) [10].
Does melatonin improve sleep quality?
Possibly, but the evidence comes from clinical groups [6][2]. A meta-analysis of 23 randomized trials in adults with various diseases found melatonin improved scores on the Pittsburgh Sleep Quality Index, a questionnaire, by 1.24 points [6]. Results varied widely between studies, and the authors found no effect in some disease groups [6]. In people with diagnosed sleep disorders the improvement was 0.67 points [6]. A meta-analysis in primary sleep disorders found a small improvement in overall sleep quality [2]. These are clinical populations; results may not apply to healthy adults.
Does melatonin help with jet lag?
Most trials found less jet lag, but the largest single trial did not [7][8]. A Cochrane review of 10 placebo-controlled trials in airline passengers, airline staff and military personnel found that 9 reported less jet lag when melatonin was taken close to the target bedtime at the destination after flights crossing five or more time zones [7]. The review estimated that about 2 people needed to take melatonin for 1 to benefit, and expected the benefit to be greater the more time zones were crossed and smaller for westward flights [7]. NCCIH summarizes later reviews from 2010 and 2014: four studies with 142 travelers found melatonin may beat placebo for overall jet lag symptoms after eastward flights [25].
Against that, a randomized, double-blind trial of 257 Norwegian physicians returning from New York, a 6-hour eastward flight, found no difference between placebo and three melatonin regimens in jet lag scores, sleep onset or hours slept [8]. A 2006 meta-analysis that pooled jet lag and shift-work trials found no clear evidence of an effect on the time to fall asleep, a different outcome from jet lag symptoms [9]. The Cochrane review was published in 2002, and its outcomes were mostly subjective ratings of jet lag and related symptoms [7].
What the evidence does not show
A 2006 meta-analysis also found no clear evidence of an effect on the time to fall asleep in people with secondary sleep disorders (6 trials, 97 participants) [9]. The rapid evidence assessment of 35 randomized trials made no recommendation for shift workers and called for larger, longer trials with well-characterized products before recommendations for young, healthy adults [24]. A 2026 systematic review found no efficacy data for young children with typical development [23].
Doses used in studies
Ranges researchers used, not dosing advice. Bars share one scale. Read our disclaimer.
Timing and form
After an immediate-release oral dose, melatonin reached its peak level in about 50 minutes, and its half-life (the time to clear half of it) was 45 minutes, according to a systematic review of 22 pharmacokinetic studies [17]. Only about 15% of an oral dose reaches the bloodstream, with a range of 9 to 33% across studies [17]. Age, caffeine, smoking, oral contraceptives and whether a person has eaten all affected these figures [17].
Formulation changes how melatonin behaves in the body [18]. A systematic review of 19 papers covered oral, transdermal, buccal, topical, intravenous and nasogastric forms and found formulation and dose affect pharmacokinetics, but could not recommend specific formulations for specific sleep disorders [18]. Most insomnia trials in the 2023 meta-analysis used prolonged-release melatonin [5], while the Cochrane review found 2 mg slow-release melatonin relatively ineffective for jet lag [7].
Timing findings from studies:
- In the 2024 meta-analysis, the time between dose and sleep predicted the effect, and the authors suggested that a dose 3 hours before the desired bedtime might work better than one 30 minutes before [3].
- In jet lag trials, melatonin taken at the wrong time, early in the day, was liable to cause sleepiness and delay adaptation to local time [7].
- In nine healthy young men given melatonin at 7 a.m., performance on a psychomotor vigilance test was impaired for 6 hours [13].
What it is
Melatonin is a hormone that the brain produces in response to darkness, and it helps time the body's 24-hour circadian rhythms and sleep [25]. Light at night can block the body's own melatonin production [25]. Supplements can be made from animals or microorganisms, but most are made synthetically [25].
In the US, synthetic melatonin is widely available over the counter, and sales rose from $285 million in 2016 to $821 million in 2020 [22]. It comes as tablets, capsules, liquids and gummies [25].
How the body breaks it down: a small study in seven healthy volunteers suggests the liver enzymes CYP1A2 and CYP2C19 break melatonin down [19].
Safety and interactions
Safety flag. In a systematic review of 37 trials, the most frequent adverse events were daytime sleepiness (1.66%), headache (0.74%) and dizziness (0.74%), and none were life threatening [14]. Long-term safety evidence is scarce [14][25]. Product content often differs from the label, by -83% to +478% in one analysis [20] and from 0% to 667% in an FDA survey of children's products [21]. US poison centers recorded 260,435 pediatric melatonin ingestions from 2012 to 2021, a 530% rise in the annual number [22].
Who sources say should be careful.
- Pregnant or breastfeeding women. Health Canada's monograph says not to use melatonin if pregnant or breastfeeding [27], and the NHS says it is not usually used in pregnancy or while breastfeeding [26]. NCCIH notes a lack of safety research in this group [25].
- Children. In Australia, pharmacist-only supply covers only two adult uses, so any other melatonin product, including one for a child, is prescription-only [28]. NCCIH advises parents to speak with a health care provider first and notes possible, unconfirmed effects on hormonal development [25].
- People with epilepsy, liver or kidney problems, or autoimmune conditions. The NHS says melatonin may not be suitable for them [26]; Health Canada adds cardiovascular and immune disease, asthma and diabetes to the conditions to discuss first [27].
- Older adults. NCCIH says melatonin may stay active longer in older people and cause daytime drowsiness [25].
- People taking the medicines listed under interactions [26][27].
In trials of people with sleep disorders, most lasting 4 weeks or less, adverse events were few and generally mild to moderate [14]. A systematic review of 37 randomized placebo-controlled trials, with daily doses from 0.15 mg to 12 mg, found the most frequently reported adverse events were daytime sleepiness (1.66%), headache (0.74%), dizziness (0.74%) and hypothermia (0.62%), and identified none that were life threatening [14]. Most of those trials lasted 4 weeks or less, only eight were rated good for risk of bias, and the authors said the scarcity of long-term trials limits conclusions about continuous use [14]. A 2006 meta-analysis of 17 trials with 651 participants found no evidence of adverse effects with use of three months or less [9].
At doses of 10 mg or more, a meta-analysis identified 79 trials with 3,861 adults across a wide range of medical conditions, but only four met its low risk-of-bias criteria [15]. In those four, melatonin caused no detectable increase in serious adverse events but did appear to raise the risk of drowsiness, headache and dizziness, and 29 of the 79 studies did not report adverse events at all [15]. The authors note their confidence limits were very wide because so few suitable data existed [15]. A safety review reports only mild effects such as dizziness, headache, nausea and sleepiness [16]. The NHS lists daytime sleepiness, headaches, stiff or painful joints and nausea or vomiting as side effects [26]. NCCIH notes a possible risk of allergic reactions and says long-term safety information is lacking [25].
Sources advise caution with driving. The NHS advises not driving, cycling or using machinery after taking melatonin [26], and Health Canada's monograph requires labels to say to avoid driving or using machinery for 5 hours [27].
Product quality is a documented problem [20][21]. In a laboratory analysis of supplements, melatonin content ranged from -83% to +478% of the label, more than 71% missed the label claim by over 10%, lot-to-lot content varied by as much as 465%, and 26% contained serotonin [20]. A survey of 110 US products marketed for children, by FDA scientists, found melatonin content from 0% to 667% of the label [21]. NCCIH reports a 2023 study in which 22 of 25 over-the-counter gummy products were inaccurately labeled, with 74 to 347 percent of the stated amount in those containing melatonin [25].
Accidental ingestion by children has risen sharply in the US [22]. US poison centers recorded 260,435 pediatric melatonin ingestions from 2012 to 2021, and the annual number rose 530%, mainly from unintentional ingestions among children aged 5 or under [22]. Among those reported cases, five children required mechanical ventilation and two died [22].
Interactions sources report
One antidepressant, fluvoxamine, raised the body's own melatonin levels in a small study [19], and the NHS lists it among medicines that may not mix with melatonin [26]. In a randomized-order crossover study of seven healthy volunteers, fluvoxamine increased the body's own melatonin exposure 2.8-fold compared with placebo, while citalopram had no significant effect [19].
Blood thinners and seizure-related risks appear across sources. The Cochrane review notes case reports suggesting harm in people with epilepsy and people taking warfarin [7], and NCCIH says people with epilepsy or taking blood thinners need medical supervision when using melatonin [25]. The NHS lists anti-inflammatory painkillers (NSAIDs) such as ibuprofen, drowsiness-causing medicines such as zopiclone, blood thinners such as warfarin, fluvoxamine, carbamazepine, the combined contraceptive pill and HRT as medicines that may not mix well with melatonin [26]. Health Canada's monograph tells people taking medicines for seizures, blood pressure, immune suppression, mental state or sedation, or steroids or blood thinners, to ask a health care practitioner first, and to avoid alcohol or other products that cause drowsiness [27].
If you take any of these medicines, talk to your doctor or pharmacist before combining them with melatonin.
Regulatory status
| Market | Status | Notes |
|---|---|---|
| US | No FDA statement specific to melatonin found as of November 11, 2026; FDA does not approve dietary supplements before they are marketed. NCCIH says melatonin is considered a dietary supplement in the US. | |
| UK | Not verified as of November 11, 2026. We checked the GOV.UK search API and the BNF melatonin page (HTTP 403) and could not confirm the MHRA licensing status. The NHS describes melatonin as a medicine only available with a prescription. | |
| Canada | Licensable as a natural health product under Health Canada's oral melatonin monograph (dated December 19, 2025): adults 18 and over, 0.1-10 mg a day (0.5-10 mg for jet lag), as-needed use for occasional sleeplessness. | |
| Australia | Pharmacist-only (Schedule 3) for two specified adult uses; all other products prescription-only (Schedule 4), per the Poisons Standard in force on November 11, 2026 (October 2026 instrument), with pack-size limits. | |
| EU | Not verified as of November 11, 2026. We checked the European Commission health-claims register, which could not be fetched (the page needs JavaScript), and could not confirm melatonin's status in the EU. |
FAQ
How much melatonin did studies use?
Jet lag trials used 0.5-5 mg a day, and doses above 5 mg appeared no more effective [7]. A 2024 dose-response meta-analysis found effects on falling asleep and total sleep peaked at 4 mg/day [3]. Trials reviewed for side effects used 0.15-12 mg a day [14]. These are study doses, not advice.
Does melatonin help with jet lag?
Most trials found less jet lag, but the largest single trial did not. A Cochrane review found 9 of 10 trials reported less jet lag after flights crossing five or more time zones [7], while a trial of 257 physicians flying 6 hours east found no difference from placebo [8].
What do sources say about long-term use?
A systematic review of 37 trials found most lasted 4 weeks or less and said the scarcity of long-term trials limits conclusions about continuous use [14]. NCCIH says information on long-term safety is lacking [25].
Why can melatonin doses differ from the label?
In one analysis of supplements, content ranged from -83% to +478% of the label and 26% contained serotonin [20]. An FDA survey of 110 children's products found 0% to 667% of the declared amount [21].
References
- Brzezinski A, Vangel MG, Wurtman RJ, et al. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev. 2005.
- Ferracioli-Oda E, Qawasmi A, Bloch MH. Meta-analysis: melatonin for the treatment of primary sleep disorders. PLoS One. 2013.
- Cruz-Sanabria F, Bruno S, Crippa A, et al. Optimizing the Time and Dose of Melatonin as a Sleep-Promoting Drug: A Systematic Review of Randomized Controlled Trials and Dose-Response Meta-Analysis. J Pineal Res. 2024.
- Choi K, Lee YJ, Park S, et al. Efficacy of melatonin for chronic insomnia: Systematic reviews and meta-analyses. Sleep Med Rev. 2022.
- Maruani J, Reynaud E, Chambe J, et al. Efficacy of melatonin and ramelteon for the acute and long-term management of insomnia disorder in adults: A systematic review and meta-analysis. J Sleep Res. 2023.
- Fatemeh G, Sajjad M, Niloufar R, et al. Effect of melatonin supplementation on sleep quality: a systematic review and meta-analysis of randomized controlled trials. J Neurol. 2022.
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database Syst Rev. 2002.
- Spitzer RL, Terman M, Williams JB, et al. Jet lag: clinical features, validation of a new syndrome-specific scale, and lack of response to melatonin in a randomized, double-blind trial. Am J Psychiatry. 1999.
- Buscemi N, Vandermeer B, Hooton N, et al. Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis. BMJ. 2006.
- Liira J, Verbeek JH, Costa G, et al. Pharmacological interventions for sleepiness and sleep disturbances caused by shift work. Cochrane Database Syst Rev. 2014.
- Attenburrow ME, Cowen PJ, Sharpley AL. Low dose melatonin improves sleep in healthy middle-aged subjects. Psychopharmacology (Berl). 1996.
- Duffy JF, Wang W, Ronda JM, et al. High dose melatonin increases sleep duration during nighttime and daytime sleep episodes in older adults. J Pineal Res. 2022.
- Graw P, Werth E, Kräuchi K, et al. Early morning melatonin administration impairs psychomotor vigilance. Behav Brain Res. 2001.
- Besag FMC, Vasey MJ, Lao KSJ, et al. Adverse Events Associated with Melatonin for the Treatment of Primary or Secondary Sleep Disorders: A Systematic Review. CNS Drugs. 2019.
- Menczel Schrire Z, Phillips CL, Chapman JL, et al. Safety of higher doses of melatonin in adults: A systematic review and meta-analysis. J Pineal Res. 2022.
- Andersen LP, Gögenur I, Rosenberg J, et al. The Safety of Melatonin in Humans. Clin Drug Investig. 2016.
- Harpsøe NG, Andersen LP, Gögenur I, et al. Clinical pharmacokinetics of melatonin: a systematic review. Eur J Clin Pharmacol. 2015.
- Moroni I, Garcia-Bennett A, Chapman J, et al. Pharmacokinetics of exogenous melatonin in relation to formulation, and effects on sleep: A systematic review. Sleep Med Rev. 2021.
- von Bahr C, Ursing C, Yasui N, et al. Fluvoxamine but not citalopram increases serum melatonin in healthy subjects-- an indication that cytochrome P450 CYP1A2 and CYP2C19 hydroxylate melatonin. Eur J Clin Pharmacol. 2000.
- Erland LA, Saxena PK. Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content. J Clin Sleep Med. 2017.
- Pawar RS, Coppin JP, Khanna S, et al. A Survey of Melatonin in Dietary Supplement Products Sold in the United States. Drug Test Anal. 2025.
- Lelak K, Vohra V, Neuman MI, et al. Pediatric Melatonin Ingestions - United States, 2012-2021. MMWR Morb Mortal Wkly Rep. 2022.
- Kracht CL, Bolamperti G, Breeden R, et al. Melatonin Use in Young Children: A Systematic Review. JAMA Netw Open. 2026.
- Costello RB, Lentino CV, Boyd CC, et al. The effectiveness of melatonin for promoting healthy sleep: a rapid evidence assessment of the literature. Nutr J. 2014.
- National Center for Complementary and Integrative Health (NIH). Melatonin: What You Need To Know. May 2024.
- NHS. Melatonin: a medicine used for sleep problems. Updated November 6, 2026.
- Health Canada, Natural and Non-prescription Health Products Directorate. Natural Health Products Ingredients Database monograph: Melatonin - Oral. Updated December 19, 2025.
- Australian Government, Department of Health, Disability and Ageing (Federal Register of Legislation). Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327). Updated September 30, 2026.
- U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Updated August 27, 2026.