Lemborexant
Dayvigo (lemborexant) is a small molecule pharmaceutical. Lemborexant was first approved as Dayvigo on 2020-04-07. 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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FDA Novel Drug Approvals 2019
Commercial
Trade Name
FDA
EMA
Dayvigo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lemborexant
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DAYVIGO | Eisai | N-212028 RX | 2020-04-07 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dayvigo | New Drug Application | 2021-03-29 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LEMBOREXANT, DAYVIGO, EISAI INC | |||
| 2026-04-20 | M-293 | ||
| 2025-04-07 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
33 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | 1 | 1 | — | — | — | 1 | ||
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 9 | — | — | — | — | 9 | ||
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 2 | — | — | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Respiration disorders | D012120 | J00-J99 | 1 | — | — | — | — | 1 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LEMBOREXANT |
| INN | lemborexant |
| Description | Lemborexant, sold under the brand name Dayvigo, is an orexin antagonist medication which is used in the treatment of insomnia. It is indicated specifically for the treatment of insomnia characterized by difficulties with sleep onset and/or maintenance in adults. The medication is taken by mouth.
|
| Classification | Small molecule |
| Drug class | Orexin receptor antagonist; Hypnotic; Sedative |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ncc(OC[C@@]2(c3cccc(F)c3)C[C@H]2C(=O)Nc2ccc(F)cn2)c(C)n1 |
Identifiers
| PDB | — |
| CAS-ID | 1369764-02-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545367 |
| ChEBI ID | — |
| PubChem CID | 56944144 |
| DrugBank | DB11951 |
| UNII ID | 0K5743G68X (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
No data
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 229 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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645 adverse events reported
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