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Melatonin

Generic Name
Melatonin
Brand Names
Circadin, Slenyto, Melatonin Neurim
Drug Type
Small Molecule
Chemical Formula
C13H16N2O2
CAS Number
73-31-4
Unique Ingredient Identifier
JL5DK93RCL

Overview

Melatonin is a biogenic amine that is found in animals, plants and microbes. Aaron B. Lerner of Yale University is credited for naming the hormone and for defining its chemical structure in 1958. In mammals, melatonin is produced by the pineal gland. The pineal gland is small endocrine gland, about the size of a rice grain and shaped like a pine cone (hence the name), that is located in the center of the brain (rostro-dorsal to the superior colliculus) but outside the blood-brain barrier. The secretion of melatonin increases in darkness and decreases during exposure to light, thereby regulating the circadian rhythms of several biological functions, including the sleep-wake cycle. In particular, melatonin regulates the sleep-wake cycle by chemically causing drowsiness and lowering the body temperature. Melatonin is also implicated in the regulation of mood, learning and memory, immune activity, dreaming, fertility and reproduction. Melatonin is also an effective antioxidant. Most of the actions of melatonin are mediated through the binding and activation of melatonin receptors. Individuals with autism spectrum disorders (ASD) may have lower than normal levels of melatonin. A 2008 study found that unaffected parents of individuals with ASD also have lower melatonin levels, and that the deficits were associated with low activity of the ASMT gene, which encodes the last enzyme of melatonin synthesis. Reduced melatonin production has also been proposed as a likely factor in the significantly higher cancer rates in night workers.

Indication

Used orally for jet lag, insomnia, shift-work disorder, circadian rhythm disorders in the blind (evidence for efficacy), and benzodiazepine and nicotine withdrawal. Evidence indicates that melatonin is likely effective for treating circadian rhythm sleep disorders in blind children and adults. It has received FDA orphan drug status as an oral medication for this use. A number of studies have shown that melatonin may be effective for treating sleep-wake cycle disturbances in children and adolescents with mental retardation, autism, and other central nervous system disorders. It appears to decrease the time to fall asleep in children with developmental disabilities, such as cerebral palsy, autism, and mental retardation. It may also improve secondary insomnia associated with various sleep-wake cycle disturbances. Other possible uses for which there is some evidence for include: benzodiazepine withdrawal, cluster headache, delayed sleep phase syndrome (DSPS), primary insomnia, jet lag, nicotine withdrawal, preoperative anxiety and sedation, prostate cancer, solid tumors (when combined with IL-2 therapy in certain cancers), sunburn prevention (topical use), tardive dyskinesia, thrombocytopenia associated with cancer, chemotherapy and other disorders.

Associated Conditions

  • Insomnia

Research Report

Published: Jul 21, 2025

Melatonin (DB01065): A Comprehensive Pharmacological and Clinical Monograph

Section 1: Identification and Physicochemical Profile

This section establishes the fundamental identity of melatonin, collating its various chemical identifiers and physical properties from multiple authoritative sources. This serves as the foundational data layer for the entire monograph.

1.1. Nomenclature and Chemical Identifiers

Melatonin is a well-characterized small molecule with a consistent set of identifiers across major chemical and pharmacological databases.

  • Primary Name: Melatonin.[1]
  • Systematic (IUPAC) Name: The formally recognized chemical name is N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide.[2]
  • Synonyms: The compound is known by several synonyms in scientific literature and commercial products, including Melatonine, N-Acetyl-5-methoxytryptamine, 5-Methoxy-N-acetyltryptamine, and the brand name Circadin.[1]
  • Chemical Identifiers: A comprehensive list of unique identifiers facilitates unambiguous cross-referencing in research and regulatory contexts.
  • CAS Number: 73-31-4.[1]
  • DrugBank ID: DB01065.[1]
  • PubChem CID: 896.[1]
  • ChEBI ID: CHEBI:16796.[1]
  • ChEMBL ID: ChEMBL45.[1]
  • KEGG ID: C01598.[1]
  • UNII: JL5DK93RCL.[1]
  • NSC Numbers: NSC-113928, NSC 56423.[1]
  • InChIKey: DRLFMBDRBRZALE-UHFFFAOYSA-N.[2]
  • SMILES: CC(=O)NCCC1=CNC2=C1C=C(C=C2)OC.[2]

1.2. Molecular Formula, Structure, and Weight

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/31
Not Applicable
Not yet recruiting
2025/07/29
Not Applicable
Completed
2025/07/16
Not Applicable
Not yet recruiting
2025/06/25
Phase 2
Recruiting
2025/06/24
Phase 4
Active, not recruiting
2025/05/30
Not Applicable
Recruiting
CMH Kharian Medical College
2025/04/29
Phase 1
Recruiting
Mian Muhammad Hassan Ahmed
2025/04/20
Phase 2
Not yet recruiting
2025/03/27
Phase 4
Completed
Konya City Hospital
2025/03/25
Phase 3
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
BioActive Nutritional, Inc.
43857-0020
ORAL
6 [hp_X] in 1 mL
5/14/2025

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
CIRCADIN™ PROLONGED RELEASE TABLETS 2MG
SIN13954P
TABLET, EXTENDED RELEASE
2 mg
5/4/2011

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
VOQUILY 1MG/ML SOLUCION ORAL
Clinigen Healthcare B.V.
88027
SOLUCIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Not Commercialized
MELATONINA BLUEFISH 2 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA EFG
Bluefish Pharmaceuticals Ab (Publ)
89994
COMPRIMIDO DE LIBERACIÓN PROLONGADA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
PINEALIN 2 MG COMPRIMIDOS
Agb-Pharma Ab
89212
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
MELATONINA PERRIGO 5 MG COMPRIMIDOS
Perrigo Espana S.A.
89119
COMPRIMIDO
Sin Receta
Not Commercialized
PINEALIN 5 MG COMPRIMIDOS
Agb-Pharma Ab
89209
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
PINEALIN 0,5 MG COMPRIMIDOS
Agb-Pharma Ab
89214
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
CIRCADIN 2 mg COMPRIMIDOS DE LIBERACION PROLONGADA
07392001
COMPRIMIDO DE LIBERACIÓN PROLONGADA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
MELATONINA NOXAREM 3 MG COMPRIMIDOS
Vemedia Manufacturing B.V.
88821
COMPRIMIDO
Sin Receta
Commercialized
SLENYTO 5 MG COMPRIMIDOS DE LIBERACION PROLONGADA
Rad Neurim Pharmaceuticals Eec S.A.R.L.
1181318003
COMPRIMIDO DE LIBERACIÓN PROLONGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
MELATONINA PERRIGO 3 MG COMPRIMIDOS
Perrigo Espana S.A.
89118
COMPRIMIDO
Sin Receta
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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