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Melatonin

Published: July 26, 2026Updated: August 25, 2026

Melatonin is a hormone-based medication primarily used to treat sleep disorders and jet lag by helping regulate the body's natural sleep-wake cycle. It is commonly used by individuals experiencing circadian rhythm disturbances, shift workers, and travelers crossing multiple time zones to improve sleep quality and reduce the time it takes to fall asleep.

Quick summary

Melatonin is a sleep-regulating hormone supplement used to treat insomnia, jet lag, and other sleep-wake cycle disorders.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 25, 2026Editorial policy

Key facts at a glance

ATC
N05CX02
RxNorm
unknown
Generic
Melatonin
Class
atc-n05
Brands
Restone, Melatonex, Somnicin
Availability
otc
Pregnancy
C
Lactation
caution
Half-life (h)
1
Onset (min)
30
Duration (h)
4
Routes
oral, sublingual
Forms
tablets, capsules, gummies, lozenges, oral liquids
Regions
United States, Canada, European Union countries, United Kingdom, Australia, New Zealand
Monitoring
sleep effectiveness, side effects

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
0.5mg to 5mg
Maximum
consult physician
Frequency
once daily at bedtime
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
0.5mg to 3mg
Maximum
consult physician
Frequency
once daily 30-60 minutes before bedtime
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
0.5mg to 2mg
Maximum
consult physician
Frequency
once daily at bedtime
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose that may cause significant toxicity in most adults
Chronic overdose: Prolonged use of very high doses may lead to tolerance, headache, and vivid dreams
Immediate actions
Supportive care, activated charcoal if within 1-2 hours of ingestion, monitor vital signs
Antidote
No specific antidote exists(Treatment is supportive and symptomatic)
Poison Control: 1-800-222-1222

Special Populations

9 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular prenatal monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

use lowest effective dose

Key Recommendations

use only if clearly needed and benefits outweigh risks

Monitor

fetal monitoring

Use with caution and monitor for adverse effects.

⚠

lactation

breastfeeding
caution
FDA Category
C
Dose Adjustment

use lowest effective dose

Key Recommendations

melatonin passes into breast milk, use with caution

Monitor

monitor infant for excessive drowsiness

Use with caution and monitor for adverse effects.

⚠

pediatric_age

children 3 to 12 years
caution
FDA Category
C
Dose Adjustment

weight-based dosing recommended

Key Recommendations

use under medical supervision, start with lowest dose

Monitor

monitor growth, development and sleep patterns

Use with caution and monitor for adverse effects.

✓

geriatric

elderly over 65
safe
FDA Category
C
Dose Adjustment

start with lower dose

Key Recommendations

use caution due to increased sensitivity

Monitor

monitor for next-day drowsiness

✓

renal_impairment

mild to moderate
safe
FDA Category
C
Dose Adjustment

no adjustment needed

Key Recommendations

no significant dose adjustment required

Monitor

standard monitoring

⚠

renal_impairment

severe
caution
FDA Category
C
Dose Adjustment

use with caution

Key Recommendations

monitor closely for accumulation

Monitor

monitor renal function

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
C
Dose Adjustment

consider dose reduction

Key Recommendations

metabolized in liver, use with caution

Monitor

monitor liver function

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

severe
unsafe
FDA Category
C
Dose Adjustment

avoid or significantly reduce dose

Key Recommendations

avoid use in severe hepatic impairment

Monitor

close medical supervision required

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

prescribingFDA
2023

Commonly prescribed since

Value:1998

FDA approval year for melatonin

drug_classWHO
2023

Drug class

Value:Melatonin receptor agonist

ATC code N05CD02

usageMedical guidelines
2023

Common uses

Value:Sleep disorders, jet lag, circadian rhythm disorders

Primary therapeutic indications

Primarily used for sleep-onset insomnia, circadian rhythm sleep disorders, jet lag adjustment, and sleep problems associated with shift work. May also be used in children with neurodevelopmental disorders who have sleep difficulties.

Melatonin acts on melatonin receptors (MT1 and MT2) in the suprachiasmatic nucleus of the hypothalamus to signal the brain that it is time for sleep, helping to reset the body's internal circadian rhythm and promote natural sleep initiation.

Should be taken 30-60 minutes before bedtime at the appropriate time for your sleep schedule. Common side effects include morning drowsiness, headache, and dizziness. May interact with blood thinners, immunosuppressants, and diabetes medications. Consult a healthcare provider before use during pregnancy, breastfeeding, or in children. Not intended for long-term use without medical supervision.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed August 25, 2026. · Read our editorial policy