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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 disorders—D007319F51.01
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 disordersD007319F51.0152416—27
Post-traumatic stress disordersD013313EFO_0001358F43.1———3—3
Restless legs syndromeD012148EFO_0004270G25.81—1—1—2
Sleep wake disordersD012893G47———2—2
DeliriumD003693R41.0——11—2
Bipolar disorderD001714EFO_0000289F30.9———2—2
TherapeuticsD013812———1—1
Sleep deprivationD012892F51.12———1—1
Type 2 diabetes mellitusD003924EFO_0001360E11———1—1
InflammationD007249———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F03—11——2
CravingD066249—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opioid-related disordersD009293EFO_0005611F11—5———5
AlcoholismD000437EFO_0003829F10.112———3
SleepD012890GO_0030431—2———2
Cocaine-related disordersD019970F1411———2
Smoking cessationD016540EFO_0004319—1———1
AnxietyD001007EFO_0005230F41.1—1———1
PlacebosD010919—1———1
Autistic disorderD001321EFO_0003758F84.0—1———1
Autism spectrum disorderD000067877F84.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tobacco use disorderD014029F171———12
Sleep apnea syndromesD012891EFO_0003877G47.31————1
Hepatic insufficiencyD0485501————1
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
3061
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
Q9HBV6
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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