{
  "slug": "melatonin",
  "name": "Melatonin",
  "alternate_names": [
    "Melatonin",
    "N-acetyl-5-methoxytryptamine",
    "Melatonina"
  ],
  "mechanism": [
    "MT1/MT2 receptor (MTNR1A/MTNR1B) activation regulating circadian rhythm (phase-shifting + sleep-onset)",
    "Direct free-radical scavenging with redox-active metabolites (preclinical)",
    "NF-kB inhibition (anti-inflammatory, mechanistic context)"
  ],
  "target": [
    "MTNR1A (MT1)",
    "MTNR1B (MT2)",
    "CYP1A2 (metabolizing enzyme; fluvoxamine interaction)"
  ],
  "use_case": [
    "sleep-onset support (reducing time to fall asleep)",
    "jet-lag relief",
    "circadian rhythm regulation (shift work, delayed sleep phase)"
  ],
  "body_system": [
    "SLEEP",
    "NEURO",
    "IMMUNE"
  ],
  "evidence_tier": "A",
  "evidence_anchor_pmid_count": 3,
  "dosage_range": "0.3-5 mg/day taken close to bedtime (phase-shift: 0.3-0.5 mg several hours pre-sleep; sleep-onset: 1-2 mg; jet-lag per EFSA: >=0.5 mg; dose-response effect peaks ~4 mg/day). Market caps: China <=3 mg (health-food only), Brazil <=0.21 mg, US no statutory limit.",
  "safety_notes": "No formal upper limit; consensus <=5 mg/day for adults. Short-term safety good (dizziness, drowsiness, headache ~ placebo; PMID 34923676). Long-term data limited. Not for pregnancy/lactation (insufficient data). Drowsiness / driving warning. Drug interactions: warfarin, antihypertensives, immunosuppressants, and notably the CYP1A2 inhibitor fluvoxamine (markedly raises melatonin levels). Pediatric ASD/ADHD use is an EU prescription indication (Slenyto), not OTC.",
  "regulatory": {
    "fda": "Dietary supplement under DSHEA 1994 (freely sold, no prescription); structure/function claims (sleep-onset, sleep quality, jet-lag, rhythm); no statutory daily limit; market norm 0.5-10 mg",
    "efsa": "Two authorized Art.13.1 claims: sleep-onset (>=1 mg) and jet-lag (>=0.5 mg). Member-state fragmentation (IT <=1 mg supplement, DE treats as medicine); EMA prescription drugs Circadin (PR 2 mg) and Slenyto (pediatric) exist",
    "anvisa": "RDC 587/2021: <=0.21 mg/day as a food supplement; above that regulated as a medicine. The very low cap effectively excludes most international melatonin products from the BR supplement channel"
  },
  "authorized_claims": [],
  "ingredient_hub_url": "https://asxan.ai/ingredients/melatonin/",
  "related_goal_slugs": [
    "cognitive-support"
  ],
  "related_lifestyle_slugs": [
    "high-stress",
    "senior-60-plus"
  ],
  "last_evidence_review": "2026-06-13",
  "schema_version": "nc-public-v0.2",
  "api_version": "nc-public-v0.3",
  "_meta": {
    "last_evidence_review": "2026-06-13",
    "ip_axes_disclosed": {
      "public_axes": [
        "mechanism",
        "target",
        "use_case",
        "body_system",
        "evidence_tier",
        "dosage_range",
        "safety_notes",
        "regulatory",
        "authorized_claims"
      ],
      "ip_axes_not_exposed": [
        "proprietary_formula_ratios",
        "clinical_protocol_internals",
        "rnd_pipeline_compounds",
        "supplier_specific_grade_specifications",
        "unpublished_endpoint_data"
      ],
      "rationale": "asxan.ai surfaces the educational, evidence-tier-disclosed slice. Formula composition, clinical-protocol internals, and RnD pipeline data are intentionally outside this public surface."
    }
  }
}