Over-the-counter medication · Hormone Supplement (Sleep Aid)
melatonin
Also sold as Melatonin. This medicine is used to help with sleep problems.
Data updated 2026-05-15
- 51,370
- FDA reportsOften reported
- 2
- InteractionsFew interactions
- OTC
- Availability
What the data shows
melatonin (Melatonin) is an over-the-counter Hormone Supplement (Sleep Aid), reported at a middle-of-the-pack volume (51,370 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
melatonin (Melatonin) is an over-the-counter Hormone Supplement (Sleep Aid). This medicine is used to help with sleep problems.
Melatonin is a hormone supplement that can help with sleep. You should take it 15 minutes before eating.
Verify with FDA → · CMS NADAC pricing →
What it does
This medicine is used to help with sleep problems.
Common side effects
Tiredness, Nausea, Diarrhea
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from melatonin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Melatonin is a hormone that your brain makes. It helps control your sleep and wake cycles. Taking this medicine adds more melatonin to your body.
Side Effects (from patient reports)
Based on 51,370 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for melatonin, by number of reports
- Fatigue
Fatigue
4,196 reports
- Nausea
Nausea
3,592 reports
- Diarrhoea
Diarrhoea
2,866 reports
- Headache
Headache
2,798 reports
- Dyspnoea
Dyspnoea
2,436 reports
- Insomnia
Insomnia
2,429 reports
- Fall
Fall
2,301 reports
- Pain
Pain
2,252 reports
- Dizziness
Dizziness
2,219 reports
- Vomiting
Vomiting
2,123 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for melatonin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where melatonin sits
melatonin has more FDA adverse-event reports than 73% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is melatonin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 51,370 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
51,370
Reports Mentioning Death
4,506
8.8% of reports — not proof of cause
Hospitalization Reports
17,241
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 4,196 |
| 2 | NAUSEA | 3,592 |
| 5 | DIARRHOEA | 2,866 |
| 6 | HEADACHE | 2,798 |
| 7 | DYSPNOEA | 2,436 |
| 8 | INSOMNIA | 2,429 |
| 9 | FALL | 2,301 |
| 10 | PAIN | 2,252 |
| 11 | DIZZINESS | 2,219 |
| 12 | VOMITING | 2,123 |
| 13 | DEATH | 2,032 |
| 14 | SOMNOLENCE | 1,842 |
| 15 | ASTHENIA | 1,818 |
| 16 | CONSTIPATION | 1,800 |
| 17 | ANXIETY | 1,702 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g., theophylline, duloxetine, melatonin), CYP2D6 (e.g., atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g., omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g., midazolam, pimozide, simvastatin) is necessary when VYVANSE is co-administered [see Clinical Pharmacology (12.3) ] .
Mechanism: Lisdexamfetamine does not change how the body's enzymes break down melatonin.
7.3 Beta-Adrenergic Receptor Antagonists (e.g., acebutolol, metoprolol) Beta-adrenergic receptor antagonists have been shown to reduce the production of melatonin via specific inhibition of beta-1 adrenergic receptors.
Mechanism: Both of these products target the same sleep receptors in your brain. Using them together could cause excessive sleepiness or change how the prescription medicine works.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What is this medicine for?
How should I take this medicine?
What should I do if I miss a dose?
Can I take this medicine if I am pregnant?
Can I take this medicine if I am breastfeeding?
What are the side effects of this medicine?
Can I take more than the recommended dose?
How should I store this medicine?
Can I drive or operate machinery while taking this medicine?
What should I do if I have a serious side effect?
What are the common side effects of melatonin?
Does melatonin interact with other medications?
What drug class is melatonin?
What pregnancy or breastfeeding source fields are listed for melatonin?
Related Medications in Hormone Supplement (Sleep Aid)
Other drugs grouped near melatonin - same-class peers and common alternatives.
eszopiclone
Lunesta
Eszopiclone (Lunesta) is a medicine that helps you fall asleep and stay asleep.
Compare with melatonin →
lemborexant
Dayvigo
Dayvigo is a medicine that can help you fall asleep and stay asleep.
Compare with melatonin →
ramelteon
Rozerem
Ramelteon (Rozerem) is a prescription medicine that can help you fall asleep faster.
Compare with melatonin →
suvorexant
Belsomra
Belsomra is a prescription medicine used to treat insomnia.
Compare with melatonin →
tasimelteon
Hetlioz
Tasimelteon (Hetlioz) is a medicine that helps people with Non-24-Hour Sleep-Wake Disorder (Non-24) sleep better.
Compare with melatonin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for melatonin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 51,370.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 8.77%.
- glipizide Δ 0.02 pts · 59,560 reports · Sulfonylurea 8.75%death share
- erythromycin Δ 0.03 pts · 18,237 reports · Macrolide Antibiotic 8.81%death share
- ertapenem Δ 0.04 pts · 3,848 reports · Carbapenem Antibiotic 8.81%death share
- pravastatin Δ 0.04 pts · 18,936 reports · HMG-CoA Reductase Inhibitor (Statin) 8.81%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for melatonin
The FDA label for melatonin (sold under brand names such as Melatonin) classifies it as an over-the-counter product in the Hormone Supplement (Sleep Aid) class. This medicine is used to help with sleep problems. Official labeling lists 5 commonly reported side effects, including Tiredness, Nausea, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 51,370 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 22, 2018
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages