is melatonin fda approved?

no. in the united states it is sold as a dietary supplement under the 1994 dietary supplement health and education act, so the fda does not review it for safety or effectiveness before sale, does not verify the dose in the bottle, and has never approved it for insomnia or anything else. in the uk and eu it is a prescription medicine: prolonged-release melatonin 2 mg (circadin) has been authorised since 2007 for short-term insomnia in adults 55 and over, and a pediatric form (slenyto) since 2018 for children with autism spectrum disorder or smith-magenis syndrome.

how much melatonin is actually in a gummy?

often not what the label says. of 25 us melatonin gummy products analysed in 2023, 22 (88%) were inaccurately labelled; measured content ran from 74% to 347% of the label, one "3 mg" gummy contained 10.4 mg, and one contained no melatonin but 31.3 mg of cbd. an earlier analysis of 31 canadian products found content from 83% below to 478% above the label and lot-to-lot variation of up to 465% within one product, with serotonin detected in 8 of them (none in the us gummies). nobody checks these products before sale.

is melatonin safe for kids?

the trials cannot answer that, and the poison-center data give reason for care. us poison control centers logged 260,435 pediatric melatonin ingestions from 2012 to 2021, a 530% rise, mostly unintentional in children aged 5 and under; melatonin was 4.9% of all pediatric ingestions reported in 2021 against 0.6% in 2012; five children needed mechanical ventilation and two died. gummies as directed can deliver 40 to 130 times the amount needed to reach normal night-time blood levels. melatonin is a hormone, and its long-term effects on puberty and reproductive hormones in children are unstudied. the only regulator-approved pediatric use anywhere on this page is the eu’s, for children with autism spectrum disorder or smith-magenis syndrome. a pediatrician, and a locked cupboard, are the two questions.

what is melatonin actually good for?

shifting the body clock. in delayed sleep phase disorder, pooled trials found it advanced the body’s own melatonin onset by 1.18 hours and moved sleep onset 0.67 hours earlier, with no change in total sleep; a cochrane review found it worked for jet lag in 9 of 10 trials. for ordinary chronic insomnia the pooled benefit is about seven minutes and the sleep medicine guideline recommends against it. taken at the wrong time of day it can shift the clock the wrong way, so the timing question belongs with a prescriber or pharmacist.

Supplement evidence

Melatonin

The sleep evidence, and how much melatonin is actually in the bottle.

page first published 2026-09-08 · last updated 2026-10-05

Not an FDA-approved treatmentSold as a dietary supplement5 studies on this page

What Its Legal Status Actually Means

Read this before anything below it. Legal to sell is not the same fact as reviewed, verified, or approved.

In the United States melatonin is sold over the counter as a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA does not review it for safety or effectiveness before sale, does not verify that a tablet or gummy contains the dose printed on the label, and has never approved melatonin to treat insomnia or any other condition. That regulatory posture is unusual internationally: melatonin is a hormone, and in the United Kingdom and the European Union it is a prescription-only medicine, not a supplement — prolonged-release melatonin (Circadin, 2 mg) has been authorised by the European Medicines Agency since 2007 for short-term treatment of insomnia in adults aged 55 and over, and a paediatric prolonged-release formulation (Slenyto) was authorised in 2018 for insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome. A British traveller cannot buy at a pharmacy what an American buys at a supermarket checkout, and the American product's actual content is not verified by anyone.

Quoted whole from the 2026-08-18 study harvest. Not summarized, not shortened.

does melatonin work for sleep? what the trials, the regulators and the poison centers say

there is no fda label for melatonin, because in the united states it is sold as a dietary supplement and has never been reviewed for safety or effectiveness; in the uk and eu it is a prescription medicine. the regulatory facts below come from the legal-status paragraph above, written from the regulator’s documents in the 2026-08-18 study harvest; every trial figure is from a study record on this page, and the poison-center figures are from the cdc report cited at the end. every source is linked at the end of this section. last checked 2026-10-05.

melatonin is a hormone the brain makes at night, sold in the united states as a supplement for sleep and given to children as gummies. it is one of the most-searched substances on this site. the evidence has three parts that do not point the same way: what the trials found it does for sleep, which is small and specific; what independent chemists found in the bottles, which is not what the labels say; and what poison centers have counted in children, which is a public-health problem of the last decade. this section covers each, in both directions, with the funders named. every figure is from a study record on this page or from the cdc report cited at the end, and each source is linked.

this is information to take to a prescriber or pharmacist. nothing here tells anyone to take melatonin or to stop, and nothing here is a reason to put off treatment that works for insomnia.

what its legal status means, and does not mean

in the united states melatonin is sold over the counter as a dietary supplement under the 1994 dietary supplement health and education act. the fda does not review it for safety or effectiveness before sale, does not verify that a tablet or gummy contains the dose printed on the label, and has never approved melatonin to treat insomnia or any other condition [status]. legal to sell is not the same fact as reviewed, verified or approved.

that posture is unusual. melatonin is a hormone, and in the united kingdom and the european union it is a prescription-only medicine: prolonged-release melatonin 2 mg (circadin) has been authorised by the european medicines agency since 2007 for the short-term treatment of insomnia in adults aged 55 and over, and a pediatric prolonged-release form (slenyto) was authorised in 2018 for insomnia in children and adolescents with autism spectrum disorder or smith-magenis syndrome [status]. the european approvals are narrow: one for older adults, one for two specific pediatric conditions, neither for general insomnia at any age. a british traveller cannot buy at a pharmacy what an american buys at a supermarket checkout, and the american product’s actual content is not verified by anyone [status].

what the trials measured, in whom, and for how long

two pooled analyses carry the sleep evidence. the broad one pooled 19 randomised placebo-controlled trials in 1,683 adults and children with primary sleep disorders and measured time to fall asleep, total sleep time and sleep quality [ferracioli-oda-2013]. the narrow one pooled 9 trials, 5 in 91 adults and 4 in 226 children, in people with delayed sleep phase disorder, whose body clock runs late, and measured how far melatonin moved the clock [van-geijlswijk-2010]. a professional-society guideline then graded the whole literature for chronic insomnia in adults [aasm-2017].

what was not measured matters as much. none of these trials tested the gummies and tablets americans actually buy for their content, which two chemistry studies did separately [erland-2017; cohen-2023]. no trial on this page ran longer than a few weeks, and melatonin’s long-term effects on puberty and reproductive hormones in children are unstudied [risks].

what the research says, in both directions

in favour. across 19 trials and 1,683 people, melatonin shortened the time to fall asleep by 7.06 minutes (95% ci 4.37 to 9.75), lengthened total sleep by 8.25 minutes (1.74 to 14.75) and improved sleep quality by a small standardised amount (0.22); all three are statistically significant [ferracioli-oda-2013]. in delayed sleep phase disorder it did what a clock-shifter should: it advanced the body’s own melatonin onset by 1.18 hours (0.89 to 1.48), moved the clock time of falling asleep 0.67 hours earlier (0.45 to 0.89) and cut sleep-onset latency by 23.27 minutes (4.83 to 41.72) [van-geijlswijk-2010]. a cochrane review of melatonin for jet lag, verified for this page but omitted as not a mental-health outcome, found 9 of 10 trials positive [exclusions].

against, or smaller than the badge suggests. seven minutes. the authors of the broad meta-analysis state directly that "the absolute benefit of melatonin compared to placebo is smaller than other pharmacological treatments for insomnia" [ferracioli-oda-2013]. in delayed sleep phase disorder, wake-up time and total sleep time did not change: melatonin moved when sleep started, it did not make anyone sleep more, and taken at the wrong hour it can push the clock the wrong way [van-geijlswijk-2010]. the american academy of sleep medicine’s 2017 guideline, after a grade-based review, says: "we suggest that clinicians not use melatonin as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults", in the same list that recommends against valerian, tryptophan, trazodone and diphenhydramine [aasm-2017]. the recommendation is graded weak, which under grade reflects low certainty in the evidence rather than a strong claim that melatonin does nothing, and every one of the guideline’s 14 recommendations is weak, including those for prescription hypnotics; but it is a recommendation not to use it [aasm-2017].

who paid. the delayed-sleep-phase meta-analysis had no sponsor and its authors declared no conflicts [van-geijlswijk-2010]. the broad meta-analysis was partly funded by two eli lilly research awards alongside nih grants; lilly sells no melatonin product, so there is no proponent conflict on this question [ferracioli-oda-2013]. the guideline was funded by the academy itself, and members with industry consulting ties recused themselves from the corresponding drug recommendations [aasm-2017]. the two chemistry studies were funded by the canadian research council and, for the us gummies, carry no funding statement [erland-2017; cohen-2023].

what is actually in the bottle

the most concrete documented risk is that the product is not what the label says. chemical analysis of 31 melatonin supplements bought in canada in 2016 found content from 83% below to 478% above the labelled amount, lot-to-lot variation within a single product of up to 465%, and more than 71% of products off their own label by more than 10%; the variation was unrelated to manufacturer or product type. serotonin, a controlled substance in that context, was found in 8 of the 31, at 1 to 75 micrograms [erland-2017].

in 2023 the same question was put to 25 melatonin gummy products sold in the united states: 22 (88%) were inaccurately labelled and only 3 were within 10% of the declared dose; measured content ran from 74% to 347% of the label; one product labelled 3 mg contained 10.4 mg; and one contained no detectable melatonin at all but 31.3 mg of cbd. serotonin was not detected in any us product, so that finding has not replicated here. the authors calculate that a child taking these gummies as directed could receive 40 to 130 times the 0.1 to 0.3 mg needed to raise blood melatonin into the normal night-time range [cohen-2023]. both studies are small, 31 and 25 products, one sample per brand in the us study, and they measure label accuracy, not clinical harm [erland-2017; cohen-2023].

children: what the poison centers counted

the cdc’s morbidity and mortality weekly report for june 2022 analysed every isolated melatonin ingestion in people aged 19 and under reported to us poison control centers from 2012 to 2021: 260,435 in ten years, with the annual number rising 530%. melatonin accounted for 4.9% of all pediatric ingestions reported to poison centers in 2021 against 0.6% in 2012, and in 2020 it became the most frequently ingested substance among children reported to them. hospitalizations and serious outcomes rose over the period, driven mainly by unintentional ingestions in children aged 5 and under. five children required mechanical ventilation and two died. us melatonin sales grew from 285 million dollars in 2016 to 821 million in 2020 [lelak-2022]. pubmed records an erratum for this report, which is a correction, not a retraction [exclusions].

the harvest adds the things the trials cannot answer: melatonin is a hormone, so its long-term effects on puberty and reproductive hormones in children are genuinely unstudied; case reports raise concerns in people with epilepsy and in people taking warfarin; and it commonly causes next-day grogginess, headache and daytime sleepiness [risks]. its accepted place is in circadian problems, jet lag and a late-running clock, not in chronic insomnia [risks; aasm-2017].

questions for a prescriber or pharmacist about melatonin

each one comes from a warning or a study above. they are questions, not instructions; the answers depend on a history nobody here has.

is my problem that i cannot fall asleep until very late, or that i cannot sleep at all? the trials say melatonin shifts the clock and does not add sleep; which one do i have?
the sleep medicine guideline recommends against melatonin for ongoing insomnia. if that is what i have, what would you use instead, and is cbt for insomnia available to me?
the pooled trials found melatonin gets people to sleep about seven minutes sooner. is that worth taking a hormone nightly, or should we look at what is keeping me awake?
the gummies tested in the us contained 74% to 347% of the labelled dose. is there a tested product you would ask for, and does the one i have state a third-party test?
if this is for my child: the poison-center numbers rose 530% in ten years, mostly in children under five, and the hormone’s long-term effects on puberty are unstudied. what would you want to know before a child takes it, and how is it stored?
i take warfarin or have epilepsy. the harvest records case-report concerns for both; does that change anything?
at what time relative to my own sleep would a dose shift the clock the right way rather than the wrong way?

questions people ask

does melatonin work for sleep?: a little, for a specific thing. across 19 trials and 1,683 people, melatonin shortened the time to fall asleep by about 7 minutes and lengthened sleep by about 8 minutes, effects the authors themselves call smaller than other treatments. in people whose body clock runs late (delayed sleep phase disorder) it moved sleep onset about 40 minutes earlier and advanced the clock by over an hour, without adding total sleep. the american academy of sleep medicine’s 2017 guideline suggests clinicians not use melatonin for chronic insomnia in adults; the recommendation is graded weak, as are all 14 in that guideline.
is melatonin fda approved?: no. in the united states it is sold as a dietary supplement under the 1994 dietary supplement health and education act, so the fda does not review it for safety or effectiveness before sale, does not verify the dose in the bottle, and has never approved it for insomnia or anything else. in the uk and eu it is a prescription medicine: prolonged-release melatonin 2 mg (circadin) has been authorised since 2007 for short-term insomnia in adults 55 and over, and a pediatric form (slenyto) since 2018 for children with autism spectrum disorder or smith-magenis syndrome.
how much melatonin is actually in a gummy?: often not what the label says. of 25 us melatonin gummy products analysed in 2023, 22 (88%) were inaccurately labelled; measured content ran from 74% to 347% of the label, one "3 mg" gummy contained 10.4 mg, and one contained no melatonin but 31.3 mg of cbd. an earlier analysis of 31 canadian products found content from 83% below to 478% above the label and lot-to-lot variation of up to 465% within one product, with serotonin detected in 8 of them (none in the us gummies). nobody checks these products before sale.
is melatonin safe for kids?: the trials cannot answer that, and the poison-center data give reason for care. us poison control centers logged 260,435 pediatric melatonin ingestions from 2012 to 2021, a 530% rise, mostly unintentional in children aged 5 and under; melatonin was 4.9% of all pediatric ingestions reported in 2021 against 0.6% in 2012; five children needed mechanical ventilation and two died. gummies as directed can deliver 40 to 130 times the amount needed to reach normal night-time blood levels. melatonin is a hormone, and its long-term effects on puberty and reproductive hormones in children are unstudied. the only regulator-approved pediatric use anywhere on this page is the eu’s, for children with autism spectrum disorder or smith-magenis syndrome. a pediatrician, and a locked cupboard, are the two questions.
what is melatonin actually good for?: shifting the body clock. in delayed sleep phase disorder, pooled trials found it advanced the body’s own melatonin onset by 1.18 hours and moved sleep onset 0.67 hours earlier, with no change in total sleep; a cochrane review found it worked for jet lag in 9 of 10 trials. for ordinary chronic insomnia the pooled benefit is about seven minutes and the sleep medicine guideline recommends against it. taken at the wrong time of day it can shift the clock the wrong way, so the timing question belongs with a prescriber or pharmacist.

sources for this section

the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.

What the Research Shows

5 records from the 2026-08-18 harvest, each checked against PubMed and Europe PMC on that date. How a study was designed, how many people were in it, and who paid for it are printed above what it found, because those three facts decide how much the finding is worth.

Study 1 · 2017
- Clinical guideline
- Reputable journal
- Independently funded
- Declared conflicts of interest
gold standard86/100
Top of the evidence hierarchy, independently funded.
Read this first: All 14 recommendations in this guideline are WEAK, including the ones in favour of prescription hypnotics, and the task force explicitly notes that evidence quality is routinely downgraded because most hypnotic trials are industry-funded. So the guidance against melatonin sits in a field of uniformly thin evidence rather than reflecting a uniquely poor showing. Several task-force members disclosed industry consulting relationships and recused themselves from the corresponding drug recommendations.
After a GRADE-based systematic review of randomized trials, the American Academy of Sleep Medicine's guideline states: "We suggest that clinicians not use melatonin as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults." That is a recommendation against, in the same list that recommends against valerian, tryptophan, trazodone, and diphenhydramine. The recommendation is graded WEAK, which under GRADE reflects low certainty of the underlying evidence rather than a strong claim that melatonin is useless — but it is a recommendation not to use it.
Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. (2017). Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. Journal of Clinical Sleep Medicine. PMID 27998379.
How this record was checked
PubMed record 27998379 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, and the melatonin recommendation quoted above confirmed verbatim from the abstract's RECOMMENDATIONS section. PMC full text (PMC5263087) retrieved 2026-08-18: the Disclosure Statement reads "The development of this clinical practice guideline was funded by the American Academy of Sleep Medicine" and lists individual member conflicts and recusals, hence funding INDEPENDENT (professional society, no commercial sponsor) and conflicts true.
Study 2 · 2010
- Meta-analysis of randomized trials
- 317 participants
- Reputable journal
- No funding reported
- Declared conflicts of interest
gold standard87/100
Top of the evidence hierarchy, independently funded.
Read this first: Nine small trials totalling 317 people, published in 2010, and the benefit is a shift of roughly 40 minutes to an hour in when sleep starts — real, but modest, and it delivers no extra total sleep. Effect depends heavily on taking the dose at the right time relative to one's own melatonin onset; taken at the wrong hour it can push the clock the wrong way.
Pooling 5 randomized trials in 91 adults and 4 in 226 children with delayed sleep phase disorder, melatonin advanced the body's own melatonin onset by 1.18 hours (95% CI 0.89-1.48), moved clock-time of falling asleep 0.67 hours earlier (95% CI 0.45-0.89), and cut sleep-onset latency by 23.27 minutes (95% CI 4.83-41.72). Wake-up time and total sleep time did not change significantly. This is melatonin's real job: it shifts the timing of the body clock in people whose clock is late. It does not make you sleep more.
van Geijlswijk IM, Korzilius HP, Smits MG. (2010). The use of exogenous melatonin in delayed sleep phase disorder: a meta-analysis. Sleep. PMID 21120122.
How this record was checked
PubMed record 21120122 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, the 5 adult trials (n=91) and 4 paediatric trials (n=226), the 1.18 h endogenous melatonin onset advance, the 0.67 h sleep-onset advance, the 23.27 minute latency reduction, and the null results for wake-up time and total sleep time confirmed verbatim from the abstract. PMC full text (PMC2982730) retrieved 2026-08-18: the Disclosure Statement reads "This was not an industry supported study. The authors have indicated no financial conflicts of interest" and the Acknowledgments read "No sponsorship was received", hence funding NONE and independent true.
Study 3 · 2013
- Meta-analysis of randomized trials
- 1,683 participants
- Indexed journal
- Mixed funding
- Declared conflicts of interest
strong75/100
Well-supported by good-quality research.
Read this first: The competing-interests statement records that the work was "partly funded by APIRE/Eli Lilly Psychiatric Research Fellowship" and "the AACAP/Eli Lilly Pilot Research Award" alongside NIH grants, so the funding is mixed rather than fully independent — though Eli Lilly markets no melatonin product, so there is no proponent conflict on this specific question. The pooled 7-minute and 8-minute effects are statistically significant and clinically trivial; readers who see melatonin described as "effective" are usually seeing this paper's conclusion divorced from its numbers.
Across 19 randomized placebo-controlled trials in 1,683 adults and children with primary sleep disorders, melatonin cut the time taken to fall asleep by 7.06 minutes (95% CI 4.37 to 9.75) and increased total sleep time by 8.25 minutes (95% CI 1.74 to 14.75), with a small improvement in sleep quality (standardized mean difference 0.22). Seven minutes. The authors state directly that "the absolute benefit of melatonin compared to placebo is smaller than other pharmacological treatments for insomnia."
Ferracioli-Oda E, Qawasmi A, Bloch MH. (2013). Meta-analysis: melatonin for the treatment of primary sleep disorders. PLOS ONE. PMID 23691095.
How this record was checked
PubMed record 23691095 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, the 19 studies and 1,683 subjects, sleep latency WMD 7.06 minutes (95% CI 4.37-9.75), total sleep time WMD 8.25 minutes (95% CI 1.74-14.75), and sleep quality SMD 0.22 (95% CI 0.12-0.32) confirmed verbatim from the abstract, along with the competing-interests statement naming the two Eli Lilly-supported awards. Europe PMC core record fetched 2026-08-18 additionally lists NIMH K23 MH091240 and NCRR UL1 RR024139; both statements read, hence funding MIXED.
Study 4 · 2017
- Cross-sectional study
- 31 participants
- Reputable journal
- Independently funded
- Declared conflicts of interest
moderate60/100
Reasonable evidence with real limitations.
Read this first: Thirty-one samples of Canadian products bought in 2016; it does not measure how common the problem is across the whole market, and the later US gummy analysis (Cohen 2023, below) did not detect serotonin in any product it tested, so the serotonin contamination finding has not been replicated in the US supply.
Chemical analysis of 31 commercial melatonin supplement samples found actual melatonin content ranging from 83% below to 478% above the labelled amount, with lot-to-lot variation within a single product of as much as 465%; more than 71% of products missed their own label by more than a 10% margin, and the variability was unrelated to manufacturer or product type. Serotonin — a controlled substance in this context — was detected in 8 of the supplements at 1 to 75 micrograms. Someone taking "the same" melatonin nightly may be taking a fifth of the stated dose one month and five times it the next.
Erland LA, Saxena PK. (2017). Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content. Journal of Clinical Sleep Medicine. PMID 27855744.
How this record was checked
PubMed record 27855744 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, the 31 supplements analyzed, the -83% to +478% content range, the 465% lot-to-lot variation, the ">71% missed label within a 10% margin" figure, and serotonin in 8 supplements at 1-75 micrograms confirmed verbatim from the abstract. PMC full text (PMC5263083) retrieved 2026-08-18: the Disclosure Statement reads "This work was supported by the National Sciences and Engineering Research Council (NSERC) of Canada grant number 46741. The authors have indicated no financial conflicts of interest", hence funding INDEPENDENT.
Study 5 · 2023
- Cross-sectional study
- 25 participants
- Top-tier journal
- Funding not established
- Declared conflicts of interest
early signal49/100
Suggestive but preliminary. Not settled.
Read this first: The authors state their own limits: only 25 products, one sample per brand, gummies only, and no test of whether tablets and capsules behave the same or whether a given brand varies batch to batch. It measures label accuracy, not clinical harm.
Of 25 US melatonin gummy products analysed, 22 (88%) were inaccurately labelled and only 3 (12%) contained melatonin within 10% of the declared amount; measured content ranged from 74% to 347% of the label, one product labelled 3 mg contained 10.4 mg, and one product contained no detectable melatonin at all but 31.3 mg of CBD. Serotonin was not detected in any product. The authors calculate that a child taking these gummies as directed could receive 40 to 130 times the 0.1-0.3 mg needed to raise blood melatonin into the normal night-time range.
Cohen PA, Avula B, Wang YH, Katragunta K, Khan I. (2023). Quantity of Melatonin and CBD in Melatonin Gummies Sold in the US. JAMA. PMID 37097362.
How this record was checked
PubMed record 37097362 fetched via NCBI efetch 2026-08-18 confirming title, authors, journal (JAMA), year, DOI and the conflict-of-interest disclosures. PMC full text (PMC10130950) retrieved 2026-08-18: Results confirm 25 products analysed, melatonin 74% to 347% of labelled quantity, 22 of 25 (88%) inaccurately labelled with only 3 (12%) within ±10%, one product with no detectable melatonin but 31.3 mg CBD, brand S labelled 3 mg measuring 10.4 mg (347%), CBD 104-118% of label in the 5 products declaring it, and "Serotonin was not detected in any product." No funding or support statement appears in the article, so funding is recorded UNKNOWN rather than inferred.

The Risks

Nobody checks this purchase the way a prescription is checked. No prescriber reviews it against the rest of what you take, no pharmacist screens the interaction, and no regulator confirms the dose in the capsule before it is sold. That is why this section sits here at full length rather than as a footnote.

What the paragraph below covers:

Accidental ingestion by children
Drug interactions
What is actually in the product
Sleep disruption
Sedation

The most concrete documented risk is that the bottle is not what the label says. Independent chemical analyses have found melatonin content ranging from 83% below to 478% above the label claim, lot-to-lot variation within a single product of up to 465%, serotonin contamination in a quarter of Canadian products tested, and 88% of US melatonin gummy brands inaccurately labelled — including one product that contained no detectable melatonin at all but 31.3 mg of CBD. A "3 mg" gummy has been measured at 10.4 mg. Clinically, melatonin commonly causes next-day grogginess, headache, and daytime sleepiness, and taken at the wrong time of day it shifts the body clock in the wrong direction and makes matters worse. Paediatric exposure has become a real public-health problem: US poison centres logged 260,435 paediatric melatonin ingestions from 2012 to 2021 with the annual number rising 530%; melatonin accounted for 4.9% of all paediatric poison-centre ingestions in 2021 versus 0.6% in 2012; five children required mechanical ventilation and two died. It is a hormone, so long-term effects on puberty and reproductive hormones in children are genuinely unstudied, and case reports raise concerns in people with epilepsy and those taking warfarin. Its accepted place is in circadian problems — jet lag and delayed sleep phase — not in chronic insomnia, where the American Academy of Sleep Medicine recommends against it.

What Is Not Known

The boundaries of the section above, in the harvest’s own words. What it excluded, why, and where it looked and found nothing. An absence of evidence is not evidence of absence, and it is not evidence of benefit either.

What Was Left Out, and Why

Quoted from the harvest, where these notes sat above the study list rather than after it. Where a note says “below” it means the studies in the section above.

Herxheimer & Petrie 2002 Cochrane review of melatonin for jet lag (PMID 12076414, doi 10.1002/14651858.CD001520) was verified end-to-end but omitted: jet lag is not a mental-health outcome, and the delayed sleep phase meta-analysis below carries the same circadian point with quantified phase shifts. Its conclusion (9 of 10 trials positive, NNT 2) is consistent with it.
Lelak et al., "Pediatric Melatonin Ingestions - United States, 2012-2021", MMWR Morb Mortal Wkly Rep 2022;71(22):725-729 (PMID 35653284, doi 10.15585/mmwr.mm7122a1) was verified via NCBI efetch 2026-08-18 and is quoted in known_risks below rather than entered as a study record; note that PubMed flags an Erratum (MMWR 2022;71(27):885) for it, not a retraction.
Salanitro 2022 (Neurosci Biobehav Rev, PMID 35691474) verified but omitted as overlapping the two meta-analyses below; its findings point the same way (benefit in delayed sleep phase disorder and in neurodevelopmental disorders, not in general adult insomnia).

The Retraction Check

PubMed efetch records for all five PMIDs inspected 2026-08-18 for "Retraction in", "Expression of concern", "Erratum in", and "Withdrawn" flags; none present.

Questions for a Prescriber or Pharmacist

This page does not tell anyone to take Melatonin or to avoid it. It is not able to: it does not know what else you take, what you have tried, or what you are treating. These are the questions each study above raises, written to be asked out loud.

The sleep medicine guideline actually recommends against melatonin for ongoing insomnia — if that's what I have, what would you use instead, and is CBT for insomnia available to me?
If my problem is that I can't fall asleep until 3am rather than that I can't sleep at all, would timed melatonin actually be the right tool — and what time should I take it?
The pooled evidence says melatonin gets people to sleep about seven minutes sooner — is that worth taking a hormone nightly, or should we look at what's actually keeping me awake?
Since supplement melatonin has been measured at anywhere from a fifth to nearly five times the label dose, is there a brand you'd trust, or a tested product I should ask for instead?
If melatonin gummies routinely contain more than the label says — and some contain CBD — is there a form or brand you would actually recommend for my child, or should we not use it?

And the one to ask at the counter, whatever the answers above turn out to be: given everything I am already taking, what would you want to know about Melatonin before I put it in the same body?

Open Melatonin in veisund

The app has the resources behind this page and people working through the same questions.What you post there goes to people, not to a model. If someone answers, it is a person who has been there. The one automated message is a crisis-resource reply.

Where This Page Comes From

Transcribed from the study-harvest-2026-08-18 record for melatonin, built into this page by scripts/supplement-ingest.mjs on 2026-09-07. Nothing here is fetched at page load, and nothing here was written by a model without a citation behind it.

Source file	study-harvest/2026-08-18/melatonin.yaml
Source repo	REPTechnologies/avalo-backend
SHA-256	38e5d9138239925908bdcfa0e2a336c037e49117969334b0546a117873a8716f
Also searched as	melatonin, Circadin, Slenyto, N-acetyl-5-methoxytryptamine, melatonin gummies

The Other Substances

Do any supplements actually work? asks the question across all of them. The full library has the medication records, the funding investigations, and the glossary.