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Sublingual Melatonin
Melatonin binds to melatonin receptors (MT1 and MT2) in the brain to regulate circadian rhythm and promote sleep.
Melatonin binds to melatonin receptors (MT1 and MT2) in the brain to regulate circadian rhythm and promote sleep. Used for Insomnia and sleep-onset disorders, Circadian rhythm sleep disorders.
At a glance
| Generic name | Sublingual Melatonin |
|---|---|
| Sponsor | Al-Azhar University |
| 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 produced by the pineal gland that acts as a circadian regulator. When administered sublingually, it crosses the blood-brain barrier and activates melatonin receptors, particularly MT1 and MT2 subtypes, which modulate sleep-wake cycles and circadian-dependent physiological processes. This mechanism makes it effective for treating sleep disorders and circadian rhythm disturbances.
Approved indications
- Insomnia and sleep-onset disorders
- Circadian rhythm sleep disorders
Common side effects
- Headache
- Dizziness
- Drowsiness
- Nausea
Key clinical trials
- The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery (PHASE4)
- Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery (NA)
- The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation (PHASE4)
- SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty (NA)
- Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN) (PHASE2)
- Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture (NA)
- Honey to Improve Sleep Quality: a Feasibility Study (NA)
- The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study (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:
- Sublingual Melatonin CI brief — competitive landscape report
- Sublingual Melatonin updates RSS · CI watch RSS
- Al-Azhar University portfolio CI