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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Dayvigo
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dayvigo | New Drug Application | 2023-12-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| sleep initiation and maintenance disorders | — | D007319 | F51.01 |
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
43 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 | 4 | 2 | 4 | 2 | 3 | 15 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 3 | — | 1 | — | 4 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 1 | — | 1 | — | 2 |
| Circadian rhythm sleep disorders | D020178 | — | G47.2 | — | 1 | — | 1 | — | 2 |
| Dyssomnias | D020920 | — | — | — | — | — | 1 | — | 1 |
| Parasomnias | D020447 | — | G47.5 | — | — | — | 1 | — | 1 |
| Syndrome | D013577 | — | — | — | — | — | 1 | — | 1 |
| Frontotemporal dementia | D057180 | HP_0002145 | G31.0 | — | — | — | 1 | — | 1 |
| Primary progressive aphasia | D018888 | EFO_0009053 | G31.01 | — | — | — | 1 | — | 1 |
| Pick disease of the brain | D020774 | EFO_0003096 | G31.01 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep | D012890 | GO_0030431 | — | — | — | 2 | — | — | 2 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | 1 | — | — | 1 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Analgesia | D000698 | — | — | 1 | 1 | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | 1 | — | — | — | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 1 | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | 1 | — | — | — | 1 |
| Sleep wake disorders | D012893 | — | G47 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | — | 10 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 2 | — | — | — | — | 2 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | 2 | — | — | — | — | 2 |
| Apnea | D001049 | HP_0002104 | R06.81 | 2 | — | — | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | — | — | — | — | 1 |
| Respiration disorders | D012120 | — | J00-J99 | 1 | — | — | — | — | 1 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 1 | 1 |
| Traumatic stress disorders | D040921 | — | — | — | — | — | — | 1 | 1 |
| 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
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Trends
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Additional graphs summarizing 465 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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730 adverse events reported
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