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Drug ReportsSuvorexant
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 receptor type 2 and orexin/Hypocretin receptor type 1.
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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 & CoN-204569 RX2014-08-13
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
belsomraNew Drug Application2024-10-14
Indications
FDA
EMA
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
64 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 disordersD007319F51.015451832
Sleep wake disordersD012893G474137
ParasomniasD020447G47.53125
DyssomniasD0209202124
DeliriumD003693R41.01124
Post-traumatic stress disordersD013313EFO_0001358F43.1134
Traumatic stress disordersD040921123
Restless legs syndromeD012148EFO_0004270G25.81112
Psychomotor agitationD011595112
SyndromeD013577112
Show 26 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opioid-related disordersD009293EFO_0005611F111517
Substance-related disordersD019966EFO_0003890F133114
Alzheimer diseaseD000544EFO_0000249F03112
CravingD066249111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlcoholismD000437EFO_0003829F10.1346
Alcohol drinkingD000428EFO_0004329234
SleepD012890GO_003043122
Cocaine-related disordersD019970F14112
Smoking cessationD016540EFO_000431911
AnxietyD001007EFO_0005230F41.111
PlacebosD01091911
Autistic disorderD001321HP_0000717F84.011
Autism spectrum disorderD000067877HP_0000729F84.011
Healthy volunteers/patients111
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AmyloidosisD000686EFO_1001875E8511
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)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(-n2nccn2)c(C(=O)N2CCN(c3nc4cc(Cl)ccc4o3)CC[C@H]2C)c1
Identifiers
PDB
CAS-ID1030377-33-3
RxCUI
ChEMBL IDCHEMBL1083659
ChEBI ID82698
PubChem CID24965990
DrugBankDB09034
UNII ID081L192FO9 (ChemIDplus, GSRS)
Target
Agency Approved
HCRTR2
HCRTR2
HCRTR1
HCRTR1
Organism
Homo sapiens
Gene name
HCRTR2
Gene synonyms
NCBI Gene ID
Protein name
orexin receptor type 2
Protein synonyms
hypocretin (orexin) receptor 2, Hypocretin receptor type 2, orexin type-2 receptor
Uniprot ID
Mouse ortholog
Hcrtr2 (387285)
orexin receptor type 2 (Q8BG12)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Belsomra Merck & Co
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,330 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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9,095 adverse events reported
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