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 diseases | D009422 |
| mental disorders | D001523 |
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 |
|---|---|---|---|---|
| BELSOMRA | Merck & Co | N-204569 RX | 2014-08-13 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| belsomra | New Drug Application | 2025-03-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| sleep initiation and maintenance disorders | — | D007319 | F51.01 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SUVOREXANT, BELSOMRA, MERCK SHARP DOHME | |||
| 2023-01-29 | M-253 | ||
HCPCS
No data
Clinical
Clinical Trials
68 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 disorders | D007319 | — | F51.01 | 5 | 4 | 5 | 20 | — | 34 |
| Sleep wake disorders | D012893 | — | G47 | — | 4 | 1 | 3 | — | 7 |
| Parasomnias | D020447 | — | G47.5 | — | 3 | 1 | 2 | — | 5 |
| Delirium | D003693 | — | R41.0 | — | 1 | 1 | 3 | — | 5 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | 4 | — | 5 |
| Dyssomnias | D020920 | — | — | — | 2 | 1 | 2 | — | 4 |
| Traumatic stress disorders | D040921 | — | — | — | 1 | — | 2 | — | 3 |
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | 1 | — | 1 | — | 2 |
| Psychomotor agitation | D011595 | — | — | — | 1 | — | 1 | — | 2 |
| Syndrome | D013577 | — | — | — | 1 | — | 1 | — | 2 |
Show 26 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 4 | 1 | — | 1 | 5 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 1 | — | — | 2 |
| Craving | D066249 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 3 | 5 | — | — | — | 7 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | 5 | — | — | — | 6 |
| Sleep | D012890 | GO_0030431 | — | — | 2 | — | — | — | 2 |
| Cocaine-related disorders | D019970 | — | F14 | 1 | 1 | — | — | — | 2 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 2 | — | — | — | 2 |
| Smoking cessation | D016540 | EFO_0004319 | — | — | 1 | — | — | — | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | — | — | — | 1 |
| Placebos | D010919 | — | — | — | 1 | — | — | — | 1 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 1 | — | — | — | 1 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tobacco use disorder | D014029 | — | F17 | 1 | — | — | — | 1 | 2 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 1 | — | — | — | — | 1 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | 1 | — | — | — | — | 1 |
| Apnea | D001049 | — | R06.81 | 1 | — | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | — | 1 |
| Obstructive lung diseases | D008173 | — | — | 1 | — | — | — | — | 1 |
| Drug misuse | D000076064 | — | — | 1 | — | — | — | — | 1 |
| Recreational drug use | D000084783 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Suvorexant |
| INN | suvorexant |
| 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 class | Orexin 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
| PDB | — |
| CAS-ID | 1030377-33-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1083659 |
| ChEBI ID | 82698 |
| PubChem CID | 24965990 |
| DrugBank | DB09034 |
| UNII ID | 081L192FO9 (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Belsomra – Merck & Co
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,650 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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9,406 adverse events reported
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