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Oral Bedtime Melatonin
Oral Bedtime Melatonin is a Melatonin receptor agonist Small molecule drug developed by Hospital San Carlos, Madrid. It is currently FDA-approved for Insomnia characterized by difficulty with sleep onset, Circadian rhythm sleep disorders. Also known as: Oral melatonin, Standard of care.
Melatonin binds to melatonin receptors (MT1 and MT2) in the suprachiasmatic nucleus to regulate circadian rhythm and promote sleep onset.
Oral bedtime melatonin is a small molecule that acts as a melatonin receptor agonist, classified as an agonist in the drug class. It has been studied for various conditions, including attention deficit/hyperactivity disorder, initial insomnia, and sleep disorders, among others.
At a glance
| Generic name | Oral Bedtime Melatonin |
|---|---|
| Also known as | Oral melatonin, Standard of care |
| Sponsor | Hospital San Carlos, Madrid |
| 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 synchronizes the body's sleep-wake cycle by activating melatonin receptors in the brain. When administered orally at bedtime, it helps reset circadian rhythm disruptions and facilitates the transition to sleep. This is particularly useful for patients with circadian rhythm disorders or insomnia related to sleep-wake cycle dysregulation.
Approved indications
- Insomnia characterized by difficulty with sleep onset
- Circadian rhythm sleep disorders
Common side effects
- Headache
- Dizziness
- Drowsiness
- Nausea
Key clinical trials
- Standardized Sleep Bundle for Cardiac Surgery Patients (NA)
- Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients (PHASE2)
- RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD) (PHASE2)
- RECOVER-SLEEP: Platform Protocol (PHASE2)
- Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy (NA)
- Melatonin for Prevention of Kidney Injury (PHASE3)
- Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial (NA)
- Melatonin for Knee Osteoarthritis Patients (NA)
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 Bedtime Melatonin CI brief — competitive landscape report
- Oral Bedtime Melatonin updates RSS · CI watch RSS
- Hospital San Carlos, Madrid portfolio CI
Frequently asked questions about Oral Bedtime Melatonin
What is Oral Bedtime Melatonin?
How does Oral Bedtime Melatonin work?
What is Oral Bedtime Melatonin used for?
Who makes Oral Bedtime Melatonin?
Is Oral Bedtime Melatonin also known as anything else?
What drug class is Oral Bedtime Melatonin in?
What development phase is Oral Bedtime Melatonin in?
What are the side effects of Oral Bedtime Melatonin?
What does Oral Bedtime Melatonin target?
Related
- Drug class: All Melatonin receptor agonist drugs
- Target: All drugs targeting MT1 and MT2 melatonin receptors
- Manufacturer: Hospital San Carlos, Madrid — full pipeline
- Therapeutic area: All drugs in Neurology / Sleep Medicine
- Indication: Drugs for Insomnia characterized by difficulty with sleep onset
- Indication: Drugs for Circadian rhythm sleep disorders
- Also known as: Oral melatonin, Standard of care
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing