All Drugs
Other · Chronobiotic hormone — endogenous pineal hormone (MT1 and MT2 melatonin receptor agonist)

Meloset (Melatonin)

Also sold as: Meloset, Circadin, Slenyto, Melzap, Zonest

Pregnancy

Cat C

Lactation

Caution

Schedule

H

Forms

Tablet 0.5mg, 1mg, 2mg, 3mg, 5mg, 10mg +2

Indications

Adult Dosing

Insomnia ≥55 years (Circadin PR)

2 mg PO 1–2 hours before bedtime for up to 13 weeks (European approval)

Effectiveness is modest — reduces sleep latency by ~12 minutes vs placebo. Very safe profile vs benzodiazepines/z-drugs. No dependency or rebound.

Jet lag

0.5–5 mg PO at bedtime at destination (starting day of arrival)

Take for 2–5 days at destination. Going east (advance phase): also 2–3 mg on departure day morning

Delayed sleep phase (insomnia)

0.5–3 mg PO 5–6 hours before desired bedtime (chronobiotic use) — not at bedtime

Advance circadian phase. Timing is critical for chronobiotic effect.

Maximum daily dose: 10 mg/day (routine); higher in clinical trials

Pediatric Dosing

Age Range: ≥2 years (ASD/neurodevelopmental — specialist)
Dose: ASD insomnia: Start 1–3 mg at bedtime; may increase to 6 mg. Paediatric specialist guidance.

Slenyto (licensed paediatric PR formulation): 1–5 mg for ASD/Smith-Magenis. Review at 1 year.

Renal Dose Adjustment

CrCl / eGFRDose Adjustment
Any CrClNo adjustment required — hepatically metabolised (CYP1A2)
Calculate eGFR / CrCl →

Hepatic Adjustment

Avoid in significant hepatic impairment — markedly increased bioavailability (hepatic first-pass effect reduced)

Pregnancy & Lactation

Pregnancy: Category C

Insufficient data in human pregnancy. Animal studies show no teratogenicity. Melatonin crosses placenta. Avoid unless essential — chronic insomnia in pregnancy: sleep hygiene first.

Lactation: Caution

Naturally present in breast milk (lowest in daytime, peaks at night). Supplemental melatonin: avoid in breastfeeding as neonatal effects unknown.

Top Drug Interactions

Interacting DrugEffectSeverity
CYP1A2 inhibitors (fluvoxamine, ciprofloxacin, caffeine)Fluvoxamine dramatically increases melatonin levels (17× increase) — avoid combinationMajor
CYP1A2 inducers (tobacco smoke, rifampicin, omeprazole)Smoking reduces melatonin levels by ~75% — smokers may need higher doses; stopping smoking → levels riseModerate
Anticoagulants (warfarin)High-dose melatonin may increase anticoagulant effect — monitor INRModerate
AntidiabeticsMelatonin may impair glucose tolerance and insulin secretion — monitor blood glucose in diabeticsModerate

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Side Effects

Common

  • Drowsiness (next day at higher doses)
  • Headache
  • Dizziness
  • Nausea
  • Irritability
  • Vivid dreams

Serious / Discontinue If

  • Seizure threshold lowering (caution in epilepsy — monitor)
  • Hypotension (at high doses)
  • Hepatotoxicity (very rare, case reports)

Contraindications

Available Indian Brands

BrandManufacturerPrice (approx)
Meloset 3mgAristo10 tab ₹85
Zonest 1mgSun Pharma10 tab ₹65
Melzap 3mgCipla10 tab ₹78
Circadin 2mg PRMundipharma/Napp30 tab ₹285 (imported)

Monitoring Required

Patient Counseling Points

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Clinically reviewed by: Dr. Vikas Desai, MD (Psychiatry), Senior Consultant Psychiatrist

Last reviewed: 2026-04-01

References

  • EMA Circadin Summary of Product Characteristics
  • Cochrane — Melatonin for Insomnia
  • BNF — Melatonin
  • AASM Clinical Practice Guidelines Melatonin 2017
  • NICE — Melatonin for Sleep Disorders in Children
Disclaimer: This information is for clinical reference only. It is not exhaustive and does not substitute clinical judgement. Always verify current dosing against the manufacturer's prescribing information and current treatment guidelines. Drug prices are approximate and may vary.