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Melatonin treatment
Melatonin treatment is a Melatonin receptor agonist Small molecule drug developed by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. It is currently FDA-approved for Insomnia and sleep disorders, Circadian rhythm disorders, Jet lag. Also known as: Melaxen.
Melatonin is a naturally occurring hormone that binds to melatonin receptors to regulate circadian rhythm and promote sleep.
Melatonin is a small molecule that acts as a melatonin receptor agonist, classified as an agonist. It has been studied as a treatment for various conditions, including Parkinson Disease, Sleep Deprivation, Intensive Care Psychosis, Primary Insomnia, and Severe Sepsis, with doses including 5 mg.
At a glance
| Generic name | Melatonin treatment |
|---|---|
| Also known as | Melaxen |
| Sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
| 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 MT1 and MT2 melatonin receptors in the suprachiasmatic nucleus and other tissues, helping to synchronize the body's internal clock with the light-dark cycle. It also has antioxidant and anti-inflammatory properties that may contribute to its therapeutic effects beyond sleep regulation.
Approved indications
- Insomnia and sleep disorders
- Circadian rhythm disorders
- Jet lag
Common side effects
- Headache
- Dizziness
- Drowsiness
- Nausea
Key clinical trials
- Melatonin for Treatment of Delirium in Critically Ill Adult Patients (PHASE2)
- PICU-related Sleep and Circadian Dysregulation Pilot Study (NA)
- Plant Protein With Ashwagandha-Rhodiola for Sleep Quality (NA)
- Standardized Sleep Bundle for Cardiac Surgery Patients (NA)
- The Effect of BWSTT on Neuroendocrine Profile and Functional Recovery in Stroke Patients (NA)
- Blue-blocking Glasses for Sleep Disorders in Child and Adolescent Psychiatry (NA)
- Safety and Efficacy of Melatonin in Patients With Multiple Progressive Primary Sclerosis (PHASE1, PHASE2)
- Sleep Disturbances in Children and Adolescents With Post-traumatic Stress Disorder (PTSD): a Randomized Double-blind Placebo-controlled Trial to Investigate the Efficacy of Pediatric Prolonged-release Melatonin (PHASE3)
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 treatment CI brief — competitive landscape report
- Melatonin treatment updates RSS · CI watch RSS
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health portfolio CI
Frequently asked questions about Melatonin treatment
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Related
- Drug class: All Melatonin receptor agonist drugs
- Target: All drugs targeting MT1 and MT2 melatonin receptors
- Manufacturer: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health — full pipeline
- Therapeutic area: All drugs in Neurology / Sleep Medicine
- Indication: Drugs for Insomnia and sleep disorders
- Indication: Drugs for Circadian rhythm disorders
- Indication: Drugs for Jet lag
- Also known as: Melaxen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing