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Suvorexant
Belsomra (suvorexant) is a small molecule pharmaceutical. Suvorexant was first approved as Belsomra on 2014-08-13. It is used to treat sleep initiation and maintenance disorders in the USA. The pharmaceutical is active against orexin/Hypocretin receptor type 1 and orexin receptor type 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Belsomra
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Suvorexant
Tradename
Company
Number
Date
Products
BELSOMRAMerck Sharp & DohmeN-204569 RX2014-08-13
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
belsomraNew Drug Application2021-02-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sleep initiation and maintenance disordersD007319F51.01
Agency Specific
FDA
EMA
Expiration
Code
SUVOREXANT, BELSOMRA, MERCK SHARP DOHME
2023-01-29M-253
Patent Expiration
Patent
Expires
Flag
FDA Information
Suvorexant, Belsomra, Merck Sharp Dohme
100988922033-05-29DP
79517972029-11-20DS, DPU-620
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05C: Hypnotics and sedatives
N05CM: Other hypnotics and sedatives in atc
N05CM19: Suvorexant
HCPCS
No data
Clinical
Clinical Trials
57 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep initiation and maintenance disordersD007319F51.015241627
Post-traumatic stress disordersD013313EFO_0001358F43.133
Restless legs syndromeD012148EFO_0004270G25.81112
Sleep wake disordersD012893G4722
DeliriumD003693R41.0112
Bipolar disorderD001714EFO_0000289F30.922
TherapeuticsD01381211
Sleep deprivationD012892F51.1211
Type 2 diabetes mellitusD003924EFO_0001360E1111
InflammationD00724911
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F03112
CravingD066249111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opioid-related disordersD009293EFO_0005611F1155
AlcoholismD000437EFO_0003829F10.1123
SleepD012890GO_003043122
Cocaine-related disordersD019970F14112
Smoking cessationD016540EFO_000431911
AnxietyD001007EFO_0005230F41.111
PlacebosD01091911
Autistic disorderD001321EFO_0003758F84.011
Autism spectrum disorderD000067877F84.011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tobacco use disorderD014029F17112
Sleep apnea syndromesD012891EFO_0003877G47.311
Hepatic insufficiencyD04855011
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSUVOREXANT
INNsuvorexant
Description
Suvorexant is an aromatic amide obtained by formal condensation of the carboxy group of 5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid with the secondary amino group of 5-chloro-2-[(5R)-5-methyl-1,4-diazepan-1-yl]-1,3-benzoxazole. An orexin receptor antagonist used for the management of insomnia. It has a role as a central nervous system depressant and an orexin receptor antagonist. It is a member of 1,3-benzoxazoles, a member of triazoles, a diazepine, an aromatic amide and an organochlorine compound.
Classification
Small molecule
Drug classOrexin receptor antagonist; Hypnotic; Sedative
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(-n2nccn2)c(C(=O)N2CCN(c3nc4cc(Cl)ccc4o3)CC[C@H]2C)c1
Identifiers
PDB4S0V
CAS-ID1030377-33-3
RxCUI1547099
ChEMBL IDCHEMBL1083659
ChEBI ID82698
PubChem CID24965990
DrugBankDB09034
UNII ID081L192FO9 (ChemIDplus, GSRS)
Target
Agency Approved
HCRTR1
HCRTR1
HCRTR2
HCRTR2
Organism
Homo sapiens
Gene name
HCRTR1
Gene synonyms
NCBI Gene ID
Protein name
orexin/Hypocretin receptor type 1
Protein synonyms
hypocretin (orexin) receptor 1, Hypocretin receptor type 1, orexin receptor 1, Orexin receptor type 1, Ox-1-R, Ox1-R, Ox1R
Uniprot ID
Mouse ortholog
Hcrtr1 (230777)
orexin/Hypocretin receptor type 1 (Q80T45)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Belsomra - Merck Sharp & Dohme
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 991 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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126 adverse events reported
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