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Oral Melatonin (4 mg)
Melatonin binds to melatonin receptors (MT1 and MT2) to regulate circadian rhythm and promote sleep.
Melatonin binds to melatonin receptors (MT1 and MT2) to regulate circadian rhythm and promote sleep. Used for Insomnia or sleep disturbances, Circadian rhythm sleep disorders.
At a glance
| Generic name | Oral Melatonin (4 mg) |
|---|---|
| Also known as | N-Acetyl-5-methoxytryptamine, Circadin, Melatonin |
| Sponsor | Woolcock Institute of Medical Research |
| Drug class | Melatonin receptor agonist |
| Target | MT1 and MT2 melatonin receptors |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | Phase 3 |
Mechanism of action
Melatonin is an endogenous hormone that acts as a circadian rhythm regulator by binding to melatonin receptors in the suprachiasmatic nucleus and other tissues. At a 4 mg oral dose, it helps synchronize sleep-wake cycles and may improve sleep onset and quality. The drug also has antioxidant and anti-inflammatory properties that may contribute to its therapeutic effects.
Approved indications
- Insomnia or sleep disturbances
- Circadian rhythm sleep disorders
Common side effects
- Headache
- Dizziness
- Drowsiness
- Nausea
Key clinical trials
- RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD) (PHASE2)
- RECOVER-SLEEP: Platform Protocol (PHASE2)
- Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder (PHASE2)
- Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients (PHASE3)
- A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study (EARLY_PHASE1)
- A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study (EARLY_PHASE1)
- Lymphatic Drainage Massage and Melatonin in Post-Orthognathic Surgery Pain and Edema (NA)
- Effect of Melatonin on Postoperative Pain After Simple Nephrectomy (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oral Melatonin (4 mg) CI brief — competitive landscape report
- Oral Melatonin (4 mg) updates RSS · CI watch RSS
- Woolcock Institute of Medical Research portfolio CI