Evidence explainerMelatonin
Melatonin Gummies: 22 of 25 Were Mislabeled, and Child Poison-Center Calls Rose Sixfold
Melatonin is sold like candy, and testing shows the dose on the label is often not the dose in the gummy. Here is what studies found and what it means for children.
Key takeaways
- In a 2023 study cited by NCCIH, 22 of 25 melatonin gummy products were inaccurately labeled, with content from 74% to 347% of the label [1].
- An earlier analysis found melatonin content from 83% below to 478% above the label, and serotonin in 26% of products [2].
- Poison-center reports of melatonin ingestion by people 19 and younger rose from 8,337 in 2012 to 52,563 in 2021 [1].
- Most of those calls (94.3%) were for children 5 and younger who swallowed melatonin accidentally at home [1].
- NCCIH advises talking with a health care provider before giving melatonin to a child [1].
Safety at a glance
From our Melatonin monograph. Published interactions and cautions only, each with its source.
Interactions
- Blood thinners. People taking blood thinners need medical supervision when taking melatonin (NCCIH); case reports raised a possible interaction with warfarin.[1][6]
- Seizure medicines / epilepsy. People with epilepsy need medical supervision when taking melatonin; case reports suggested possible harm.[1][6]
Who should be careful
- Children. Talk with a health care provider first. Dose, timing and long-term effects in children are uncertain, it may affect hormonal development, and accidental ingestion of melatonin by young children has risen sharply; store it out of reach.[1]
- Pregnancy and breastfeeding. There has been a lack of research on melatonin's safety in pregnancy and breastfeeding.[1]
- Older adults. Melatonin may stay active longer in older people and cause daytime drowsiness. The American Academy of Sleep Medicine recommends against its use by people with dementia.[1]
- Long-term use. Short-term use appears safe for most people, but long-term safety data are lacking. Allergic reactions are possible.[1]
The evidence, graded
Pulled from our monograph evidence tables. Grades follow our evidence-grading policy.
- Grade BImprovedTime to fall asleep, total sleep time and sleep qualityMelatonin shortened sleep onset by about 7 minutes, increased total sleep by about 8 minutes and modestly improved sleep quality (SMD 0.22) versus placebo. Effects did not fade with continued use.
- Grade BImprovedSleep onset and total sleep by dose and timingMelatonin gradually reduced sleep onset latency and increased total sleep time, peaking at 4 mg/day. Effects were larger in people with insomnia and when taken earlier before bedtime (about 3 hours) than the common 2 mg 30 minutes before.
What the label tests found
NCCIH reports a 2023 study in which 22 of 25 over-the-counter melatonin gummy products were inaccurately labeled [1]. One had no detectable melatonin; the rest ranged from 74% to 347% of the labeled amount, and most held 1.2 to 1.7 times what the label said [1].
A 2017 analysis of melatonin supplements found content ranging from 83% below to 478% above the label, and 26% of products contained serotonin [2].
The rise in children swallowing it
Reports to US poison control centers about people 19 and younger who took melatonin rose from 8,337 in 2012 to 52,563 in 2021, increasing every year [1]. Most calls, 94.3%, were for children 5 and younger who accidentally swallowed melatonin at home, and 82.8% of those who took it had no symptoms [1].
Hospitalizations rose too. Most involved teenagers who took intentional overdoses, and the largest increase was in children 5 and younger [1]. A CDC report estimated about 11,000 emergency visits from 2019 to 2022 for unsupervised melatonin ingestion by children 5 and younger, many involving flavored products such as gummies [1].
Melatonin for children's sleep
A 2019 review of 18 small, brief studies (1,021 children) found melatonin helped children fall asleep sooner and sleep longer than placebo [1]. Because research is limited, there are open questions about dose, timing, long-term effects and possible effects on hormonal development [1].
Guidelines for specific childhood conditions recommend behavioral approaches such as good bedtime habits first [1]. NCCIH advises parents to speak with a health care provider before using melatonin [1].
Practical steps at home
Based on what NCCIH and the CDC report, these steps address the main risks:
- Store melatonin, especially gummies, out of children's reach and sight [1].
- Expect the real dose to differ from the label, often upward [1][2].
- Talk with a health care provider before giving melatonin to a child [1].
- Adults: trials found effects peaked near 4 mg a day, so a high-dose gummy is unlikely to add benefit; see how much melatonin to take [3].
Quick answers
Are melatonin gummies stronger than the label says?
Often. In the 2023 study, most mislabeled gummies held 1.2 to 1.7 times the labeled amount, and one held 347% [1].
What happens if a child eats melatonin gummies?
In poison-center data, 82.8% of people who took melatonin had no symptoms, but hospitalizations rose over the decade [1]. Call Poison Control or a health care provider if a child swallows melatonin.
Is melatonin safe for kids long term?
NCCIH says long-term effects in children are uncertain [1].
Keep reading
Full monographs
Related articles
- How Much Melatonin Should You Take? Trials Used 0.5 to 5 mg, and Timing Mattered as Much as Dose
- Ashwagandha for Stress and Sleep: What the Trials Found, and Why the Results Vary So Much
- Ashwagandha Side Effects: The Liver, Thyroid and Pregnancy Warnings Behind Denmark’s Ban
- How Much Magnesium Is Too Much? The 350 mg Rule, the Label Trap and Who Should Be Careful
Browse the full Supplement & Nutrient Encyclopedia or all supplement articles.
References
- [1]Melatonin: What You Need To Know. NIH National Center for Complementary and Integrative Health, 2024.
- [2]Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content. J Clin Sleep Med, 2017.
- [3]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.
