Melatonin · The Ingredient Files

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Evidence by effect

Evidence strength (A–D, color) and effect size (dots, fill) are shown separately. The two axes are independent.

Claimed effect

Evidence strength

Effect size

One-line summary · key source

Relieving or preventing jet lagEvidence type: Meta-analysis

A Strong

Large

This is melatonin's clearest use and the flagship evidence that the ingredient genuinely works. In a CochraneAn international network that rigorously reviews and synthesizes evidence. review of 10 randomized trials, 9 found that melatonin taken close to the destination bedtime (10pm to midnight) reduced jet lag from flights crossing 5 or more time zones. The number needed to treat (NNT) was 2, a large effect where one of every two people who take it benefits. The benefit is greater the more time zones are crossed and for eastward travel, daily doses of 0.5-5 mg are similarly effective, and above 5 mg adds nothing. The authors concluded that melatonin is 'remarkably effective' at preventing or reducing jet lag and appears safe with short-term use. One caveat: the outcomes are subjective jet-lag ratings and the review is old. PMID: 11279722

Delayed sleep phase disorder - advancing the sleep rhythmEvidence type: Meta-analysis

B Moderate

Moderate

For people whose rhythm has shifted late - unable to sleep at night and only dropping off toward dawn - melatonin pulls the clock earlier. In a meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of delayed sleep phase disorderA circadian rhythm disorder in which sleep and wake times are pushed far later than the social norm (DSWPD). (91 adults, 226 children), melatonin advanced the time the body begins releasing its own melatonin by 1.18 hours on average and the actual clock time of falling asleep by 0.67 hours, and cut the time to fall asleep by about 23 minutes. But wake-up time and total sleep time did not change significantly - showing it is an ingredient that 'moves when you sleep,' not one that makes you 'sleep longer.' This is why melatonin should be understood as a rhythm regulator rather than a sleeping pill. PMID: 21120122

Improving ordinary insomnia - the powerful-sleeping-pill expectation (the belief)Evidence type: Meta-analysis

B Moderate

Minimal

The expectation that melatonin is a 'take it and sleep deeply' pill for ordinary insomnia outruns the evidence; the effect is real but small. In a meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of 19 randomized trials in 1,683 patients with primary sleep disorders, melatonin shortened the time to fall asleep (sleep latencyThe time it takes to actually fall asleep after going to bed; shorter means falling asleep faster.) by 7.06 minutes on average versus placeboAn inert dummy treatment used as the comparison baseline., increased total sleep time by 8.25 minutes, and significantly improved overall sleep quality (standardized mean difference 0.22). The authors called the effect 'modest' and stressed that the absolute benefit over placebo is smaller than other insomnia drugs. In exchange, it has relatively few side effects, so it has a place. In short, it makes you sleep 'a little sooner and a little more,' not a powerful sleeping pill. PMID: 23691095

Insomnia in children (autism spectrum and others) - prolonged-releaseA formulation designed to release an ingredient slowly over time (also called sustained- or extended-release). melatoninEvidence type: RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.

B Moderate

Moderate

In a specific pediatric population whose sleep does not improve with behavioral steps alone, there is randomized evidence for prolonged-releaseA formulation designed to release an ingredient slowly over time (also called sustained- or extended-release). melatonin. In a double-blind trial of 125 children and adolescents with autism spectrum disorder (some with ADHD or neurogenetic disorders), a pediatric prolonged-release melatonin (2 mg escalated to 5 mg) increased nighttime total sleep time by about 32 minutes more than placeboAn inert dummy treatment used as the comparison baseline. after 13 weeks (p=0.034) and cut the time to fall asleep by about 25 minutes more (p=0.011). The rate of clinically meaningful responders was also higher (68.9% vs 39.3%, NNT 3.38). But the trial was run by researchers from the company that makes the product (Neurim) and is a single trial, and this is a context of children with a diagnosed disorder under specialist supervision, not sleep-habit improvement in ordinary healthy children. PMID: 29096777

Reliability of the content and purity of commercial supplementsEvidence type: Observational

D Insufficient

None

Before any efficacy, the question is whether what is in the bottle matches the label. In an analysis of about 30 commercial melatonin supplements, the actual melatonin content ranged from -83% to +478% of the labeled amount (with up to 465% variation even between lots of the same product), and more than 71% of products fell outside a plus-or-minus 10% margin of the label. Moreover, 26% (8 products) contained undeclared serotoninA neurotransmitter involved in mood and sleep and a precursor of melatonin; it was detected as a contaminant in some supplements. at 1 to 75 micrograms, serotonin being a signaling compound used as a neurological drug. This means that 'how many mg you are taking' is itself uncertain and unwanted compounds may be present - a safety and quality issue that must be weighed when choosing a product, separate from the efficacy grades. PMID: 27855744

Evidence strength A Strong · B Moderate · C Weak · D Insufficient/refuted

Effect size Large → None

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Who benefits / who should be cautious

The statements in this section are translated directly from institutional sources (NIH-ODS, etc.), not our own interpretation. Consult a professional before use.

Benefit

For travel crossing 5 or more time zones, melatonin has solid evidence for reducing jet lag. A small dose (0.5-5 mg) taken close to the destination bedtime for a short period is recommended, and the benefit is greatest for eastward travel. source↗

Original text

Melatonin is remarkably effective in preventing or reducing jet-lag, and occasional short-term use appears to be safe.
Caution

The timing of the dose matters a great deal. Taken at the wrong time (early in the day) it can instead cause sleepiness and delay adaptation to local time. Melatonin is not a drug that 'makes you sleep more' but an ingredient that 'moves the body clock,' so it works only when the timing is right. source↗

Original text

The timing of the melatonin dose is important: if it is taken at the wrong time, early in the day, it is liable to cause sleepiness and delay adaptation to local time.
Caution

For ordinary insomnia, keep expectations low. Melatonin's sleep effect is modest and its absolute benefit over placeboAn inert dummy treatment used as the comparison baseline. is smaller than other insomnia drugs. Its advantage is fewer side effects, but it should not be treated as a powerful sleeping pill. source↗

Original text

The effects of melatonin on sleep are modest but do not appear to dissipate with continued melatonin use. Although the absolute benefit of melatonin compared to placebo is smaller than other pharmacological treatments for insomnia, melatonin may have a role in the treatment of insomnia given its relatively benign side-effect profile compared to these agents.
Caution

The actual content of commercial products can differ greatly from the label (-83% to +478%), and some contained serotoninA neurotransmitter involved in mood and sleep and a precursor of melatonin; it was detected as a contaminant in some supplements.. Choose products that have passed reliable quality control (such as third-party testing), and do not simply trust the labeled dose. source↗

Original text

Melatonin content did not meet label within a 10% margin of the label claim in more than 71% of supplements and an additional 26% were found to contain serotonin.
Caution

Caution is warranted for people with epilepsy or taking warfarin (an anticoagulant). Case reports flag possible harm from melatonin in these situations, so consult a professional before use. source↗

Original text

Case reports suggest that people with epilepsy, and patients taking warfarin may come to harm from melatonin.

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Form & dosage evidence

Trial doses by effect

Jet lag (Cochrane review dose): Melatonin 0.5-5 mg near the destination bedtime (10pm to midnight) - above 5 mg adds no benefit [11279722]
Insomnia in children with ASD (trial dose): Pediatric prolonged-release melatonin 2 mg escalated to 5 mg (under specialist supervision) [29096777]

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Balanced conclusion

Melatonin is on the 'actually works' side of this dossier, but the key is to understand it as an ingredient that 'moves the body clock' rather than a sleeping pill. Its firmest evidence is for jet lag, where a CochraneAn international network that rigorously reviews and synthesizes evidence. review concluded it is 'remarkably effective' (NNT 2) after flights crossing 5 or more time zones, and it also advances the time of falling asleep in delayed sleep phase disorderA circadian rhythm disorder in which sleep and wake times are pushed far later than the social norm (DSWPD)., where the clock has shifted late. For ordinary insomnia, by contrast, it only shortens the time to fall asleep by about 7 minutes on average - a modest effect, far from the expectation of a powerful sleeping pill. For insomnia in specific groups such as children with autism, there is randomized evidence for prolonged-releaseA formulation designed to release an ingredient slowly over time (also called sustained- or extended-release). melatonin, but with the limits of an industry, single trial and the premise of specialist supervision. Practically, remember two things: the timing of the dose drives the effect, and the actual content of commercial products can differ greatly from the label, with serotoninA neurotransmitter involved in mood and sleep and a precursor of melatonin; it was detected as a contaminant in some supplements. present in some. People with epilepsy or on warfarin should also be cautious. In short, it is an evidence-based choice for jet lag and sleep-rhythm problems but not a catch-all for ordinary insomnia; a quality-checked product used at the right time for a short period is the sensible approach.

Apply - Get it from food

Melatonin is a hormone the body makes itself, and while it is present in trace amounts in some foods (such as tart cherries and pistachios), those amounts are inconsistent and far below supplement doses (0.5-5 mg). In addition, trusted government and peer-reviewed food-composition databases including USDA FoodData Central do not list a melatonin content per food as a standard nutrient (this means there are no comparable content values in trusted databases, not that foods contain none). We therefore do not present a 'get it from food' table.

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Sources

Each source shows its one-line summary and key summary up front. Expand the collapsed section to read the original abstract. Every citation is verified by re-resolving through the API.

PMID 11279722 Melatonin for preventing and treating jet lag Systematic review (Cochrane) · Cochrane Database Syst Rev, 2002 9 of 10 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s - melatonin near destination bedtime reduced jet lag from 5+ time-zone flights (NNT 2). 'Remarkably effective,' safe short-term. 0.5-5 mg, timing is key.

Key summary

A CochraneAn international network that rigorously reviews and synthesizes evidence. systematic review of oral melatonin for preventing and reducing jet lag. Of 10 randomized trials meeting inclusion criteria, 9 found that melatonin taken close to the destination bedtime (10pm to midnight) reduced jet lag from flights crossing 5 or more time zones. Daily doses of 0.5-5 mg were similarly effective (falling asleep faster and better at 5 mg), above 5 mg added nothing, and the relative ineffectiveness of 2 mg slow-release suggests a short high peak works better. The NNT was 2. The benefit is greater with more time zones and eastward travel, and taking it at the wrong time (early in the day) delays adaptation. The authors concluded melatonin is remarkably effective for jet lag and appears safe short-term, adding cautions for people with epilepsy or on warfarin and a need for product quality control.

Show original abstract

BACKGROUND: Jet-lag commonly affects air travellers who cross several time zones. It results from the body's internal rhythms being out of step with the day-night cycle at the destination. Melatonin is a pineal hormone that plays a central part in regulating bodily rhythms and has been used as a drug to re-align them with the outside world. OBJECTIVES: To assess the effectiveness of oral melatonin taken in different dosage regimens for alleviating jet-lag after air travel across several time zones. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, MEDLINE, EMBASE, PsychLit and Science Citation Index electronically, and the journals 'Aviation, Space and Environmental Medicine' and 'Sleep' by hand. We searched citation lists of relevant studies for other relevant trials. We asked principal authors of relevant studies to tell us about unpublished trials. Reports of adverse events linked to melatonin use outside randomised trials were searched for systematically in 'Side Effects of Drugs' (SED) and SED Annuals, 'Reactions Weekly', MEDLINE, and the adverse drug reactions databases of the WHO Uppsala Monitoring Centre (UMC) and the US Food & Drug Administration. SELECTION CRITERIA: Randomised trials in airline passengers, airline staff or military personnel given oral melatonin, compared with placebo or other medication. Outcome measures should consist of subjective rating of jet-lag or related components, such as subjective wellbeing, daytime tiredness, onset and quality of sleep, psychological functioning, duration of return to normal, or indicators of circadian rhythms. DATA COLLECTION AND ANALYSIS: Ten trials met the inclusion criteria. All compared melatonin with placebo; one in addition compared it with a hypnotic, zolpidem. Nine of the trials were of adequate quality to contribute to the assessment, one had a design fault and could not be used in the assessment. Reports of adverse events outside trials were found through MEDLINE, 'Reactions Weekly', and in the WHO UMC database. MAIN RESULTS: Nine of the ten trials found that melatonin, taken close to the target bedtime at the destination (10pm to midnight), decreased jet-lag from flights crossing five or more time zones. Daily doses of melatonin between 0.5 and 5mg are similarly effective, except that people fall asleep faster and sleep better after 5mg than 0.5mg. Doses above 5mg appear to be no more effective. The relative ineffectiveness of 2mg slow-release melatonin suggests that a short-lived higher peak concentration of melatonin works better. Based on the review, the number needed to treat (NNT) is 2. The benefit is likely to be greater the more time zones are crossed, and less for westward flights. The timing of the melatonin dose is important: if it is taken at the wrong time, early in the day, it is liable to cause sleepiness and delay adaptation to local time. The incidence of other side effects is low. Case reports suggest that people with epilepsy, and patients taking warfarin may come to harm from melatonin. REVIEWER'S CONCLUSIONS: Melatonin is remarkably effective in preventing or reducing jet-lag, and occasional short-term use appears to be safe. It should be recommended to adult travellers flying across five or more time zones, particularly in an easterly direction, and especially if they have experienced jet-lag on previous journeys. Travellers crossing 2-4 time zones can also use it if need be. The pharmacology and toxicology of melatonin needs systematic study, and routine pharmaceutical quality control of melatonin products must be established. The effects of melatonin in people with epilepsy, and a possible interaction with warfarin, need investigation. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.

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PMID 21120122 The use of exogenous melatonin in delayed sleep phase disorder: a meta-analysis Meta-analysis · Sleep, 2010 91 adults, 226 children - melatonin advanced endogenous melatonin onset by 1.18h and sleep onset by 0.67h, cut sleep latencyThe time it takes to actually fall asleep after going to bed; shorter means falling asleep faster. 23 min; but wake time and total sleep unchanged (a rhythm-shifter).

Key summary

A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of exogenous melatonin in delayed sleep phase disorderA circadian rhythm disorder in which sleep and wake times are pushed far later than the social norm (DSWPD).. Pooling 5 randomized trials of 91 adults and 4 trials of 226 children, melatonin advanced the time the body starts releasing its own melatonin by 1.18 hours on average (95% CI 0.89-1.48), the actual clock time of falling asleep by 0.67 hours (0.45-0.89), and shortened sleep latencyThe time it takes to actually fall asleep after going to bed; shorter means falling asleep faster. by 23.27 minutes (4.83-41.72). Wake-up time and total sleep time did not change significantly. The authors concluded melatonin is effective at advancing the sleep-wake rhythm and endogenous melatonin rhythm in delayed sleep phase disorder. It shifts the position of the rhythm rather than total sleep amount.

Show original abstract

STUDY OBJECTIVES: To perform a meta-analysis of the efficacy and safety of exogenous melatonin in advancing sleep-wake rhythm in patients with delayed sleep phase disorder. DESIGN: Meta analysis of papers indexed for PubMed, Embase, and the abstracts of sleep and chronobiologic societies (1990-2009). PATIENTS: Individuals with delayed sleep phase disorder. INTERVENTIONS: Administration of melatonin. MEASUREMENTS AND RESULTS: A meta-analysis of data of randomized controlled trials involving individuals with delayed sleep phase disorder that were published in English, compared melatonin with placebo, and reported 1 or more of the following: endogenous melatonin onset, clock hour of sleep onset, wake-up time, sleep-onset latency, and total sleep time. The 5 trials including 91 adults and 4 trials including 226 children showed that melatonin treatment advanced mean endogenous melatonin onset by 1.18 hours (95% confidence interval [CI]: 0.89-1.48 h) and clock hour of sleep onset by 0.67 hours (95% CI: 0.45-0.89 h). Melatonin decreased sleep-onset latency by 23.27 minutes (95% CI: 4.83-41.72 min). The wake-up time and total sleep time did not change significantly. CONCLUSIONS: Melatonin is effective in advancing sleep-wake rhythm and endogenous melatonin rhythm in delayed sleep phase disorder. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.

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PMID 23691095 Meta-analysis: melatonin for the treatment of primary sleep disorders Meta-analysis · PLoS One, 2013 19 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s, 1,683 people - melatonin cut sleep latencyThe time it takes to actually fall asleep after going to bed; shorter means falling asleep faster. 7.06 min, added 8.25 min total sleep, improved quality SMD 0.22; effect 'modest,' smaller absolute benefit than other insomnia drugs.

Key summary

A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of melatonin versus placeboAn inert dummy treatment used as the comparison baseline. in patients with primary sleep disorders (adults and children). Pooling 19 randomized placebo-controlled trials and 1,683 subjects, melatonin reduced sleep latencyThe time it takes to actually fall asleep after going to bed; shorter means falling asleep faster. by 7.06 minutes (95% CI 4.37-9.75), increased total sleep time by 8.25 minutes (1.74-14.75), and significantly improved overall sleep quality by a standardized mean difference of 0.22 (0.12-0.32). Longer duration and higher dose gave larger latency and total-sleep effects. The authors concluded that melatonin's sleep effect is 'modest' but does not dissipate with continued use, and that although its absolute benefit over placebo is smaller than other insomnia drugs, its relatively benign side-effect profile may give it a role in insomnia.

Show original abstract

STUDY OBJECTIVES: To investigate the efficacy of melatonin compared to placebo in improving sleep parameters in patients with primary sleep disorders. DESIGN: PubMed was searched for randomized, placebo-controlled trials examining the effects of melatonin for the treatment of primary sleep disorders. Primary outcomes examined were improvement in sleep latency, sleep quality and total sleep time. Meta-regression was performed to examine the influence of dose and duration of melatonin on reported efficacy. PARTICIPANTS: Adults and children diagnosed with primary sleep disorders. INTERVENTIONS: Melatonin compared to placebo. RESULTS: Nineteen studies involving 1683 subjects were included in this meta-analysis. Melatonin demonstrated significant efficacy in reducing sleep latency (weighted mean difference (WMD) = 7.06 minutes [95% CI 4.37 to 9.75], Z = 5.15, p<0.001) and increasing total sleep time (WMD = 8.25 minutes [95% CI 1.74 to 14.75], Z = 2.48, p = 0.013). Trials with longer duration and using higher doses of melatonin demonstrated greater effects on decreasing sleep latency and increasing total sleep time. Overall sleep quality was significantly improved in subjects taking melatonin (standardized mean difference = 0.22 [95% CI: 0.12 to 0.32], Z = 4.52, p<0.001) compared to placebo. No significant effects of trial duration and melatonin dose were observed on sleep quality. CONCLUSION: This meta-analysis demonstrates that melatonin decreases sleep onset latency, increases total sleep time and improves overall sleep quality. The effects of melatonin on sleep are modest but do not appear to dissipate with continued melatonin use. Although the absolute benefit of melatonin compared to placebo is smaller than other pharmacological treatments for insomnia, melatonin may have a role in the treatment of insomnia given its relatively benign side-effect profile compared to these agents. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.

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PMID 29096777 Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder Randomized controlled trial · J Am Acad Child Adolesc Psychiatry, 2017 125 children with ASD, double-blind - prolonged-releaseA formulation designed to release an ingredient slowly over time (also called sustained- or extended-release). melatonin gave +32 min night sleep vs placeboAn inert dummy treatment used as the comparison baseline. (p=.034), -25 min latency (p=.011), responders 68.9 vs 39.3% (NNT 3.38). But an industry (Neurim) trial.

Key summary

A double-blind randomized trial comparing a pediatric prolonged-releaseA formulation designed to release an ingredient slowly over time (also called sustained- or extended-release). melatonin (PedPRM, 2 mg escalated to 5 mg) with placeboAn inert dummy treatment used as the comparison baseline. for 13 weeks in 125 children and adolescents (aged 2-17.5) with autism spectrum disorder (some with ADHD or neurogenetic disorders) whose sleep had not improved on behavioral intervention alone. The primary outcome, nighttime total sleep time, rose by 57.5 minutes on average with melatonin, significantly more than placebo (9.14 minutes; adjusted difference -32.43 minutes, p=0.034), and sleep latencyThe time it takes to actually fall asleep after going to bed; shorter means falling asleep faster. fell by 39.6 minutes with melatonin versus 12.5 with placebo (adjusted difference -25.30 minutes, p=0.011). Clinically meaningful responders were 68.9% versus 39.3% (NNT 3.38); somnolence was more common than placebo but it was generally safe. Limitations include a conflict of interest (some authors are from the manufacturer, Neurim) and that it is a single trial.

Show original abstract

OBJECTIVE: To assess the efficacy and safety of novel pediatric-appropriate, prolonged-release melatonin minitablets (PedPRM) versus placebo for insomnia in children and adolescents with autism spectrum disorder (ASD), with or without attention-deficit/hyperactivity disorder (ADHD) comorbidity, and neurogenetic disorders (NGD). METHOD: A total of 125 children and adolescents (2-17.5 years of age; 96.8% ASD, 3.2% Smith-Magenis syndrome [SMS]) whose sleep failed to improve on behavioral intervention alone were randomized (1:1 ratio), double-blind, to receive PedPRM (2 mg escalated to 5 mg) or placebo for 13 weeks. Sleep measures included the validated caregivers' Sleep and Nap Diary (SND) and Composite Sleep Disturbance Index (CSDI). The a priori primary endpoint was SND-reported total sleep time (TST) after 13 weeks of treatment. RESULTS: The study met the primary endpoint: after 13 weeks of double-blind treatment, participants slept on average 57.5 minutes longer at night with PedPRM compared to 9.14 minutes with placebo (adjusted mean treatment difference PedPRM-placebo -32.43 minutes; p = .034). Sleep latency (SL) decreased by 39.6 minutes on average with PedPRM and 12.5 minutes with placebo (adjusted mean treatment difference -25.30 minutes; p = .011) without causing earlier wakeup time. The rate of participants attaining clinically meaningful responses in TST and/or SL was significantly higher with PedPRM than with placebo (68.9% versus 39.3% respectively; p = .001) corresponding to a number needed to treat (NNT) of 3.38. Overall sleep disturbance (CSDI) tended to decrease. PedPRM was generally safe; somnolence was more commonly reported with PedPRM than placebo. CONCLUSION: PedPRM was efficacious and safe for treatment of insomnia in children and adolescents with ASD with/without ADHD and NGD. The acceptability of this pediatric formulation in a population who usually experience significant difficulties in swallowing was remarkably high. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.

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PMID 27855744 Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content Product analysis study · J Clin Sleep Med, 2017 ~30 commercial products - actual content -83% to +478% of label, 71%+ outside +/-10%; serotoninA neurotransmitter involved in mood and sleep and a precursor of melatonin; it was detected as a contaminant in some supplements. found in 26% (8 products) at 1-75 micrograms.

Key summary

A study quantifying the actual content and purity of commercial melatonin supplements. Analyzing 31 products of various brands and forms by ultraperformance liquid chromatography, melatonin content ranged from -83% to +478% of the labeled amount, with up to 465% variation between lots of the same product. This variability was not clearly correlated with manufacturer or form. Undeclared serotoninA neurotransmitter involved in mood and sleep and a precursor of melatonin; it was detected as a contaminant in some supplements. was also detected in 8 products at 1 to 75 micrograms. Only 29% of products fell within a plus-or-minus 10% margin of the label (more than 71% did not), and 26% contained serotonin. The authors concluded that stronger manufacturing controls are needed so the quality of supplements used for sleep disorders can be trusted.

Show original abstract

STUDY OBJECTIVES: Melatonin is an important neurohormone, which mediates circadian rhythms and the sleep cycle. As such, it is a popular and readily available supplement for the treatment and prevention of sleep-related disorders including insomnia and jet lag. This study quantified melatonin in 30 commercial supplements, comprising different brands and forms and screened supplements for the presence of serotonin. METHODS: A total of 31 supplements were analyzed by ultraperformance liquid chromatography with electrochemical detection for quantification of melatonin and serotonin. Presence of serotonin was confirmed through analysis by ultraperformance liquid chromatography with mass spectrometry detection. RESULTS: Melatonin content was found to range from -83% to +478% of the labelled content. Additionally, lot-to-lot variable within a particular product varied by as much as 465%. This variability did not appear to be correlated with manufacturer or product type. Furthermore, serotonin (5-hydroxytryptamine), a related indoleamine and controlled substance used in the treatment of several neurological disorders, was identified in eight of the supplements at levels of 1 to 75 μg. CONCLUSIONS: Melatonin content did not meet label within a 10% margin of the label claim in more than 71% of supplements and an additional 26% were found to contain serotonin. It is important that clinicians and patients have confidence in the quality of supplements used in the treatment of sleep disorders. To address this, manufacturers require increased controls to ensure melatonin supplements meet both their label claim, and also are free from contaminants, such as serotonin. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.

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Revision history

The full history of when and how this ingredient's evidence changed (git commits = proof of trust).

2026-07-13 First edition from real PubMed data - five melatonin assessments (a 'trust anchor': it works, honestly framed as a rhythm-shifter not a sleeping pill). (1) Jet lag A/large/meta (Cochrane Herxheimer 11279722: 9 of 10 RCTs reduced 5+ time-zone jet lag, NNT 2, 'remarkably effective,' 0.5-5 mg, timing key - the sole A anchor). (2) Delayed sleep phase disorder B/moderate/meta (van Geijlswijk 21120122: sleep onset advanced 0.67h, latency -23 min, wake/total sleep unchanged = a rhythm shift). (3) Ordinary insomnia B/minimal/meta (Ferracioli-Oda 23691095: 19 RCTs, 1683 people, latency -7.06 min, total sleep +8.25 min, quality SMD 0.22; authors 'modest,' smaller absolute benefit than other insomnia drugs = corrects the universal-sleeping-pill belief). (4) Insomnia in children with ASD B/moderate/rct (Gringras PedPRM 29096777: prolonged-release, total sleep +32 min, latency -25 min, NNT 3.38, but manufacturer Neurim COI and single trial). (5) Product content/purity D/none/obs (Erland 27855744: actual content -83% to +478% of label, 71%+ outside +/-10%, 26% contained serotonin = safety and quality warning). No authoritative openFDA label (oral melatonin is a US supplement; EU Circadin is EMA), so guidance grounded in Herxheimer, Ferracioli-Oda, Erland verbatim. Diet absent (melatonin not USDA-tracked; only trace in foods like tart cherry, far below supplement doses; `unavailable`). New category `sleep` added to i18n. Banned-word care in display text (avoided ko cure/prevention-effect wording and en cure/treats-disease/detox; verbatim abstracts exempt). Glossary tooltips (melatonin, circadian rhythm, sleep latency, delayed sleep phase disorder, prolonged-release, serotonin). Citation integrity, compliance, i18n, and dash/table conventions verified.

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