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Melatonin injection
Melatonin binds to melatonin receptors (MT1 and MT2) to regulate circadian rhythm and promote sleep-wake cycle normalization.
Melatonin binds to melatonin receptors (MT1 and MT2) to regulate circadian rhythm and promote sleep-wake cycle normalization. Used for Circadian rhythm sleep disorders, Insomnia, Sleep disturbances in hospitalized or critically ill patients.
At a glance
| Generic name | Melatonin injection |
|---|---|
| Also known as | CAS-73314 |
| Sponsor | Imperial College London |
| 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 is an endogenous hormone that acts as a chronobiotic agent, synchronizing the body's internal clock with external light-dark cycles. By activating melatonin receptors in the suprachiasmatic nucleus and other tissues, it facilitates sleep onset and maintains circadian homeostasis. The injectable formulation allows for direct systemic delivery, potentially providing more consistent pharmacokinetics than oral administration.
Approved indications
- Circadian rhythm sleep disorders
- Insomnia (sleep initiation and maintenance)
Common side effects
- Headache
- Dizziness
- Drowsiness
- Injection site reactions
Key clinical trials
- Melatonin Loaded in Injectable Platelet-Rich Fibrin in the Management Periodontitis (PHASE4)
- The Efficacy of Melatonin Patches on Dental Anxiety in Children (PHASE4)
- MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children (PHASE3)
- of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve (PHASE3)
- Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis (PHASE4)
- Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study (PHASE2)
- The Effect of Melatonin on Ischemia-reperfusion Injury Following Acute Myocardial Infarction (PHASE2)
- Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin (PHASE1, PHASE2)
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 injection CI brief — competitive landscape report
- Melatonin injection updates RSS · CI watch RSS
- Imperial College London portfolio CI