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Melatonin(Circadin®)
Melatonin is a natural hormone that binds to melatonin receptors (MT1 and MT2) in the brain to regulate circadian rhythm and promote sleep.
Melatonin is a natural hormone that binds to melatonin receptors (MT1 and MT2) in the brain to regulate circadian rhythm and promote sleep. Used for Insomnia characterized by poor quality of sleep in patients aged 55 years and older.
At a glance
| Generic name | Melatonin(Circadin®) |
|---|---|
| Also known as | Prolonged release melatonin 2mg |
| Sponsor | KIMJisun |
| Drug class | Melatonin receptor agonist |
| Target | MT1 and MT2 melatonin receptors |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | FDA-approved |
Mechanism of action
Melatonin acts as an agonist at melatonin receptors, particularly MT1 and MT2 subtypes located in the suprachiasmatic nucleus and other brain regions. This receptor activation helps synchronize the body's internal circadian clock with the external light-dark cycle, thereby promoting sleep onset and maintaining sleep architecture. Circadin® is a prolonged-release formulation designed to mimic the natural nocturnal melatonin secretion pattern.
Approved indications
- Insomnia characterized by poor quality of sleep in patients aged 55 years and older
Common side effects
- Headache
- Dizziness
- Somnolence
- Fatigue
- Back pain
Key clinical trials
- Melatonin for Treatment of Delirium in Critically Ill Adult Patients (PHASE2)
- Plant Protein With Ashwagandha-Rhodiola for Sleep Quality (NA)
- Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery (NA)
- Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial (NA)
- CTNNB1 Neurodevelopmental Syndrome - Natural History Study
- Impact of Cocaine Use and Withdrawal on Sleep
- Mechanistic Effect of Walnut Consumption on Sleep Quality (NA)
- Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma (PHASE4)
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:
- Melatonin(Circadin®) CI brief — competitive landscape report
- Melatonin(Circadin®) updates RSS · CI watch RSS
- KIMJisun portfolio CI