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.
How to Take It
Take 20 drops in a little water. Do this two times per day, 15 minutes before you eat. Follow your doctor's instructions about how much to take. Do not take more than your doctor tells you to.
This is a plain-language summary of melatonin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if this medicine is safe to take during pregnancy or while breastfeeding. Talk to your doctor before taking it if you are pregnant or breastfeeding.
This is a plain-language summary of melatonin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of melatonin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature away from heat and moisture.
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
- Tiredness
Tiredness
4,195 reports
- Feeling sick to your stomach
Feeling sick to your stomach
3,592 reports
- Loose stools
Loose stools
2,865 reports
- Head pain
Head pain
2,797 reports
- Difficulty breathing
Difficulty breathing
2,437 reports
- Trouble sleeping
Trouble sleeping
2,428 reports
- Accidental fall
Accidental fall
2,301 reports
- Aches
Aches
2,251 reports
- Feeling lightheaded
Feeling lightheaded
2,219 reports
- Throwing up
Throwing up
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) 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.
What to do: No dose adjustment is required when using these two products together.
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.
What to do: Talk to your doctor before taking over-the-counter melatonin with this prescription sleep medicine. They may advise you to avoid using both at the same time.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is melatonin safe during pregnancy?
Related Medications in Hormone Supplement (Sleep Aid)
Other drugs grouped near melatonin - same-class peers and common alternatives.
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ramelteon
Rozerem
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suvorexant
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tasimelteon
Hetlioz
Tasimelteon (Hetlioz) is a medicine that helps people with Non-24-Hour Sleep-Wake Disorder (Non-24) sleep better.
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: December 22, 2018
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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