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AboutPricing
Drug ReportsMelatonin
Melatonin
Circadin, Melatonin, Slenyto (melatonin) is a small molecule pharmaceutical. Melatonin was first approved as Circadin on 2007-06-29. It is used to treat jet lag syndrome and seasonal affective disorder in the USA. It has been approved in Europe to treat autistic disorder and sleep initiation and maintenance disorders. The pharmaceutical is active against melatonin receptor type 1B and melatonin receptor type 1A. In addition, it is known to target 5-hydroxytryptamine receptor 2B.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
24 / 7 life extra strength pain relieverOTC monograph final2023-07-19
24 / 7 life extra strength pain reliever pmOTC monograph not final2023-07-19
cardinal healthOTC monograph final2022-12-12
cvs health earwax removal drops earwax removal aidC2002632024-06-24
cvs health earwax removal kitC2002632024-06-17
cvs health first aid outdoor prep-packOTC monograph not final2017-01-20
cvs health nighttime sleep aidOTC monograph final2017-10-18
cvs health nighttime sleep-aidC2002632024-08-21
dg health sleep aidC2002632024-07-17
extra strength antacid tablets, 24/7 life extra strength antacid tablets, caseys 4goodOTC monograph final2023-08-16
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sleep initiation and maintenance disorders—D007319F51.01
jet lag syndrome—D020179G47.25
seasonal affective disorder—D016574—
autistic disorderHP_0000717D001321F84.0
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CH: Melatonin receptor agonists, hypnotics and sedatives
— N05CH01: Melatonin
HCPCS
No data
Clinical
Clinical Trials
8184 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.91228155446491
Diabetes mellitusD003920HP_0000819E08-E1310674305330
Breast neoplasmsD001943EFO_0003869C5082191242277
ObesityD009765EFO_0001073E66.95762221237
Mental disordersD001523EFO_0000677F91.93551221234
AnxietyD001007EFO_0005230F41.14863190206
Type 2 diabetes mellitusD003924EFO_0001360E116533181196
HypertensionD006973EFO_0000537I104452179194
Depressive disorderD003866EFO_1002014F32.A41694163187
Covid-19D000086382——4831166180
Show 232 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8061913—270305
Hiv infectionsD015658EFO_0000764B20324—130137
Cardiovascular diseasesD002318HP_0001626—324—128136
OverweightD050177—E66.3254—8594
SleepD012890GO_0030431—322—8793
AsthmaD001249EFO_0000270J45147—8292
ExerciseD015444EFO_0000483—221—8891
Health behaviorD015438——111—8487
Psychological distressD000079225——221—7579
Obstructive lung diseasesD008173HP_0006536——21—7376
Show 165 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pediatric obesityD063766——12——6466
Knee osteoarthritisD020370EFO_0004616M1723——4347
Caregiver burdenD000084802———1——3536
Feeding and eating disordersD001068—F5041——2832
Healthy dietD000072001——11——3032
EnuresisD004775—R32—1——3031
Adolescent behaviorD000294——12——2830
Body weightD001835EFO_0004338—11——2830
EndometriosisD004715EFO_0001065N80—1——2122
Brain neoplasmsD001932EFO_0003833C71—3——1922
Show 149 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AgingD000375GO_0007568R41.811———6162
Type 1 diabetes mellitusD003922EFO_0001359E101———4445
Suicidal ideationD059020EFO_0004320R45.8511———3435
Rheumatoid arthritisD001172EFO_0000685M06.92———2931
Psychological burnoutD000077062——1———2728
Self efficacyD020377——1———2324
Cerebral palsyD002547—G801———2122
Blood pressureD001794EFO_0004325—1———2021
Respiratory tract infectionsD012141—J06.91———1819
HypersensitivityD006967HP_0012393T78.402———1719
Show 88 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SuicideD013405——————6060
Mental healthD008603EFO_0003935—————5858
Feeding behaviorD005247——————3838
Medication adherenceD055118EFO_0006344—————3434
Coronary diseaseD003327——————3333
Colonic neoplasmsD003110—C18————3333
Child developmentD002657——————2929
PneumoniaD011014EFO_0003106—————2424
Suicide preventionD000092864——————2424
Patient participationD010358——————2424
Show 1320 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMelatonin
INN—
Description
Melatonin is a member of the class of acetamides that is acetamide in which one of the hydrogens attached to the nitrogen atom is replaced by a 2-(5-methoxy-1H-indol-3-yl)ethyl group. It is a hormone secreted by the pineal gland in humans. It has a role as a hormone, an anticonvulsant, an immunological adjuvant, a radical scavenger, a central nervous system depressant, a human metabolite, a mouse metabolite and a geroprotector. It is a member of acetamides and a member of tryptamines. It is functionally related to a tryptamine.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Identifiers
PDB—
CAS-ID73-31-4
RxCUI—
ChEMBL IDCHEMBL45
ChEBI ID16796
PubChem CID896
DrugBankDB01065
UNII ID—
Target
Agency Approved
MTNR1B
MTNR1B
Organism
Homo sapiens
Gene name
MTNR1B
Gene synonyms
NCBI Gene ID
Protein name
melatonin receptor type 1B
Protein synonyms
mel1b receptor, melatonin receptor MEL1B
Uniprot ID
Mouse ortholog
Mtnr1b (244701)
melatonin receptor type 1B (Q8CIQ6)
Alternate
NQO2
NQO2
Organism
Homo sapiens
Gene name
NQO2
Gene synonyms
NMOR2
NCBI Gene ID
Protein name
ribosyldihydronicotinamide dehydrogenase [quinone]
Protein synonyms
N-ribosyldihydronicotinamide:quinone reductase 2, NAD(P)H dehydrogenase, quinone 2, NAD(P)H menadione oxidoreductase-1, dioxin-inducible-2, NAD(P)H quinone dehydrogenase 2, NRH dehydrogenase [quinone] 2, NRH:quinone oxidoreductase 2, QR2, Quinone reductase 2, ribosyldihydronicotinamide dehydrogenase
Uniprot ID
Mouse ortholog
Nqo2 (18105)
ribosyldihydronicotinamide dehydrogenase [quinone] (Q9JI75)
Variants
No data
Financial
Revenue by drug
$
€
ÂŁ
₣
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Estimated US medical usage
Melatonin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 98,098 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,853 adverse events reported
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