Melatonin
Approved · EMAAlso known as 5-methoxy-N-acetyl tryptamine, 5-methoxy-N-acetyltryptamine, Melatonin with Vitamin B6, N-Acetyl-5-methoxytryptamine+5 more
5-methoxy-N-acetyl tryptamine, 5-methoxy-N-acetyltryptamine, Melatonin with Vitamin B6, N-Acetyl-5-methoxytryptamine, Restone, Somnicin, Melatonex, Melatonina, Mélatonine.
Recent clinical, regulatory, research and industry developments relating to this drug.
Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU
Effect of Melatonin on the Clinical Outcomes in Type 2 Diabetic Patients With Peripheral Neuropathy
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
Approval: Melatonin Neurim (EMA)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Melatonin Neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Evidence ↗Indication: Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant… Show full indicationShow less
Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.
Indication: Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Evidence ↗Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- Journal of pineal research2
- Ageing research reviews1
- Cancer1
- Food chemistry1
- Frontiers in endocrinology1
- Journal of biological rhythms1
- Reiter RJ2
- Sun J2
- Wang X2
- Abulseoud OA1
- Alatorre-Jimenez M1
- Almieda Chuffa LG1
- Altena E1
- Andersen L1
- Armenian National Institute of Health1
- Bispebjerg Hospital1
- Center for Basics in NeuroModulation (NeuroModulBasics)1
- Center for Neurogenomics and Cognitive Research1
- Center for Sleep and Chronobiology Research1
- Centre for Cognitive Neurosciences1
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.