melatonin
Brand names: Melatonin
Melatonin is a hormone supplement that can help with sleep. You should take it 15 minutes before eating.
What it does
This medicine is used to help with sleep problems.
Common side effects
Tiredness, Nausea, Diarrhea
Key warnings
There are no boxed warnings for this medication.
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.
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.
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.
Storage
Store at room temperature away from heat and moisture.
Side Effects (from patient reports)
Based on 29,122 FDA adverse event reports.
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
Death-Related Reports
4,506
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 |
| 3 | OFF LABEL USE | 3,225 |
| 4 | DRUG INEFFECTIVE | 3,031 |
| 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 |
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
Serious Warnings
There are no boxed warnings for this medication.
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.
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.
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.
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ramelteon
Rozerem
Ramelteon (Rozerem) is a prescription medicine that can help you fall asleep faster.
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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 →
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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 29,122 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.
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