Baby Safety / Compounds / Melatonin

Is Melatonin safe for babies and kids?

Moderate risk for kids

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Melatonin poses heightened risk.

What is melatonin?

The IUPAC name is N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide.

Also known as: N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide, Melatonine, N-Acetyl-5-methoxytryptamine, Circadin.

IUPAC name
N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide
CAS number
73-31-4
Molecular formula
C13H16N2O2
Molecular weight
232.28 g/mol
SMILES
CC(=O)NCCC1=CNC2=C1C=C(C=C2)OC
PubChem CID
896

Risk for babies

Moderate risk

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Melatonin poses heightened risk.

Neonates and infants up to 12 months have incomplete blood-brain barrier development, immature Phase I/II metabolic enzymes (particularly CYP3A4, UGT1A1), and higher gastrointestinal permeability. Equivalent doses produce higher internal concentrations and longer residence times.

What to do: Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Risk for pregnant and nursing people

Elevated risk

Melatonin poses pregnancy risk through potential teratogenicity, altered pharmacokinetics (increased blood volume, changed CYP activity), and placental transfer. FDA pregnancy category should be evaluated.

Suspected reproductive toxicant (GHS H361) or suspected endocrine disruptor. Precautionary approach warranted. Animal studies or limited human data suggest developmental toxicity potential.

What to do: Minimize exposure during pregnancy and lactation. Consult healthcare provider regarding specific risks. Consider alternative products with lower hazard profiles.

Regulatory consensus

1 regulatory bodyhas classified Melatonin.

AgencyYearClassificationNotes
IARC—Not classifiedIARC has not classified melatonin

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where kids encounter melatonin

  • Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
  • Occupational Environments — Factories, Warehouses, Transportation vehicles

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Melatonin:

  • Tocopherol (Vitamin E) based antioxidants
    Trade-offs: Lower thermal stability than synthetic BHT/BHA for some polymer applications.
    Relative cost: 2-5× conventional

Frequently asked questions

Is melatonin safe for kids?

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Melatonin poses heightened risk.

What products contain melatonin?

Melatonin appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments).

What should I do if my child is exposed to melatonin?

Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

See Melatonin in the baby app

Look up products containing melatonin, compare to alternatives, and explore the full data record.

Open in baby View raw API data

Sources (2)
  1. NCCIH (National Center for Complementary and Integrative Health): Melatonin — Dietary supplement US; Circadin EU prescription; 530% pediatric AAPCC increase 2012-2021; gummy formulation hazard; CYP1A2 interaction fluvoxamine; label content variability ±478%; pubertal timing concern (2022) (2022) — regulatory
  2. American Association of Poison Control Centers (AAPCC): National Poison Data System Annual Report — Pediatric cocaine/stimulant exposures; body packing emergencies; levamisole agranulocytosis; accidental child ingestion outcomes (2022) (2022) — regulatory

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →