{
 "query": "melatonin",
 "ingredient": "melatonin",
 "slug": "melatonin",
 "rxcui": "6711",
 "brands": [],
 "names": [
  "melatonin"
 ],
 "classes": [
  {
   "id": "N05CH",
   "name": "Melatonin receptor agonists"
  }
 ],
 "alternatives": [
  "ramelteon",
  "tasimelteon"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 50
  },
  "boxed_warning": "",
  "indications_and_usage": "USES: \u2022 For the temporary relief of symptoms including: \u2022 difficulty sleeping \u2022 jet lag These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.",
  "contraindications": "",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Melatonin",
  "manufacturer": "Deseret Biologicals, Inc.",
  "application_number": "",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240401",
  "set_id": "4ea9b3dc-a6f7-48b0-b0a7-ac2951bc575d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 52236,
  "serious": 34757,
  "death": 4653,
  "hospitalization": 17931,
  "primary_suspect": 51989,
  "top_reactions": [
   [
    "Fatigue",
    4260
   ],
   [
    "Nausea",
    3562
   ],
   [
    "Off Label Use",
    3378
   ],
   [
    "Drug Ineffective",
    3040
   ],
   [
    "Diarrhoea",
    2929
   ],
   [
    "Headache",
    2822
   ],
   [
    "Dyspnoea",
    2475
   ],
   [
    "Fall",
    2370
   ],
   [
    "Insomnia",
    2316
   ],
   [
    "Dizziness",
    2237
   ],
   [
    "Pain",
    2190
   ],
   [
    "Vomiting",
    2143
   ],
   [
    "Death",
    2118
   ],
   [
    "Somnolence",
    1889
   ],
   [
    "Constipation",
    1856
   ]
  ],
  "by_year": {
   "2019": 4811,
   "2020": 5343,
   "2021": 5315,
   "2022": 5151,
   "2023": 4924,
   "2024": 4863,
   "2025": 5548,
   "2026": 2546
  },
  "by_year_primary": {
   "2019": 4809,
   "2020": 5341,
   "2021": 5290,
   "2022": 5111,
   "2023": 4889,
   "2024": 4815,
   "2025": 5492,
   "2026": 2510
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 723,
  "completed": 368,
  "terminated": 64,
  "with_results": 79,
  "industry": 72,
  "phase3": 99,
  "results_share": 0.21467391304347827,
  "terminated_share": 0.08852005532503458
 },
 "pubmed": {
  "rct": 873,
  "meta": 339,
  "recent_rct": 232,
  "cochrane": [
   {
    "pmid": "41925053",
    "title": "Melatonin treatment for neonatal encephalopathy",
    "year": "2026"
   },
   {
    "pmid": "40955729",
    "title": "Melatonin for blood pressure control in adults",
    "year": "2025"
   },
   {
    "pmid": "40304216",
    "title": "Melatonin in cancer treatment",
    "year": "2025"
   },
   {
    "pmid": "33319916",
    "title": "Melatonin for preoperative and postoperative anxiety in adults",
    "year": "2020"
   },
   {
    "pmid": "31206585",
    "title": "Melatonin and agomelatine for preventing seasonal affective disorder",
    "year": "2019"
   },
   {
    "pmid": "29746721",
    "title": "Melatonin for the promotion of sleep in adults in the intensive care unit",
    "year": "2018"
   },
   {
    "pmid": "27513702",
    "title": "Melatonin as add-on treatment for epilepsy",
    "year": "2016"
   },
   {
    "pmid": "27022888",
    "title": "Melatonin for women in pregnancy for neuroprotection of the fetus",
    "year": "2016"
   },
   {
    "pmid": "26986179",
    "title": "Melatonin as add-on treatment for epilepsy",
    "year": "2016"
   },
   {
    "pmid": "26560173",
    "title": "Melatonin and agomelatine for preventing seasonal affective disorder",
    "year": "2015"
   },
   {
    "pmid": "25856551",
    "title": "Melatonin for pre- and postoperative anxiety in adults",
    "year": "2015"
   },
   {
    "pmid": "22696363",
    "title": "Melatonin as add-on treatment for epilepsy",
    "year": "2012"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "melatonin"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (1.0x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 83,
   "letter": "B",
   "why": [
    "873 randomized trials and 339 systematic reviews/meta-analyses indexed in PubMed",
    "12 independent Cochrane review(s) exist",
    "Only 21% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 60,
   "letter": "D",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 90,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over ramelteon, tasimelteon? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}