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lemborexant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| orexin receptor antagonists | 5360 | 1369764-02-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.03 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
| BA (Bioavailability) | 87 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | EIF2AK3,GRK2,PDK1,PDK2,PDK4 | 5 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 23, 2020 | PMDA | Eisai Co., Ltd | |
| Dec. 20, 2019 | FDA | EISAI INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Sleep paralysis | 257.61 | 24.66 | 41 | 2824 | 857 | 90624725 |
| Suicide attempt | 240.55 | 24.66 | 90 | 2775 | 75309 | 90550273 |
| Suicidal ideation | 202.57 | 24.66 | 79 | 2786 | 73776 | 90551806 |
| Adverse drug reaction | 74.07 | 24.66 | 46 | 2819 | 116655 | 90508927 |
| Altered state of consciousness | 73.28 | 24.66 | 30 | 2835 | 31502 | 90594080 |
| Nightmare | 65.66 | 24.66 | 25 | 2840 | 21700 | 90603882 |
| Somnolence | 56.09 | 24.66 | 49 | 2816 | 209035 | 90416547 |
| Intentional overdose | 49.63 | 24.66 | 33 | 2832 | 93801 | 90531781 |
| Hepatic function abnormal | 47.52 | 24.66 | 25 | 2840 | 46263 | 90579319 |
| Condition aggravated | 38.58 | 24.66 | 68 | 2797 | 595477 | 90030105 |
| Interstitial lung disease | 38.30 | 24.66 | 26 | 2839 | 76379 | 90549203 |
| Underdose | 33.47 | 24.66 | 21 | 2844 | 53996 | 90571586 |
| Drug ineffective | 27.82 | 24.66 | 101 | 2764 | 1384197 | 89241385 |
| Sedation | 25.58 | 24.66 | 17 | 2848 | 48154 | 90577428 |
| Physical deconditioning | 25.25 | 24.66 | 7 | 2858 | 2228 | 90623354 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Sleep paralysis | 109.26 | 23.84 | 18 | 1878 | 328 | 42619111 |
| Nightmare | 57.21 | 23.84 | 26 | 1870 | 24986 | 42594453 |
| Hepatic function abnormal | 54.86 | 23.84 | 32 | 1864 | 51535 | 42567904 |
| Pneumonia aspiration | 42.75 | 23.84 | 27 | 1869 | 50051 | 42569388 |
| Interstitial lung disease | 36.06 | 23.84 | 29 | 1867 | 78433 | 42541006 |
| Cytokine release syndrome | 35.49 | 23.84 | 23 | 1873 | 44504 | 42574935 |
| Abnormal dreams | 33.75 | 23.84 | 13 | 1883 | 8258 | 42611181 |
| Altered state of consciousness | 30.66 | 23.84 | 18 | 1878 | 29241 | 42590198 |
| Somnolence | 26.58 | 23.84 | 32 | 1864 | 141073 | 42478366 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Suicide attempt | 185.00 | 20.54 | 89 | 4551 | 103305 | 110481354 |
| Suicidal ideation | 171.49 | 20.54 | 82 | 4558 | 93855 | 110490804 |
| Sleep paralysis | 156.61 | 20.54 | 28 | 4612 | 890 | 110583769 |
| Hepatic function abnormal | 96.79 | 20.54 | 55 | 4585 | 89240 | 110495419 |
| Altered state of consciousness | 74.81 | 20.54 | 40 | 4600 | 57586 | 110527073 |
| Interstitial lung disease | 72.15 | 20.54 | 54 | 4586 | 139280 | 110445379 |
| Adverse drug reaction | 66.28 | 20.54 | 46 | 4594 | 105513 | 110479146 |
| Pneumonia aspiration | 57.17 | 20.54 | 38 | 4602 | 81195 | 110503464 |
| Nightmare | 56.18 | 20.54 | 29 | 4611 | 38834 | 110545825 |
| Cytokine release syndrome | 47.33 | 20.54 | 32 | 4608 | 70274 | 110514385 |
| Somnolence | 46.94 | 20.54 | 60 | 4580 | 297389 | 110287270 |
| Underdose | 40.58 | 20.54 | 28 | 4612 | 63526 | 110521133 |
| Physical deconditioning | 36.52 | 20.54 | 11 | 4629 | 3526 | 110581133 |
| Intentional overdose | 35.05 | 20.54 | 35 | 4605 | 132466 | 110452193 |
| Sedation | 29.50 | 20.54 | 24 | 4616 | 69659 | 110515000 |
| Cerebral infarction | 28.83 | 20.54 | 21 | 4619 | 51817 | 110532842 |
| Condition aggravated | 24.54 | 20.54 | 77 | 4563 | 734759 | 109849900 |
| Pneumonia bacterial | 22.71 | 20.54 | 14 | 4626 | 26247 | 110558412 |
| Immune-mediated hepatic disorder | 22.25 | 20.54 | 8 | 4632 | 4442 | 110580217 |
| Renal impairment | 22.13 | 20.54 | 33 | 4607 | 188412 | 110396247 |
| Aortic dissection | 21.45 | 20.54 | 8 | 4632 | 4925 | 110579734 |
| Off label use | 21.39 | 20.54 | 121 | 4519 | 1500064 | 109084595 |
| Fall | 20.83 | 20.54 | 64 | 4576 | 603418 | 109981241 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N05CJ02 | NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Orexin receptor antagonists |
| MeSH PA | D000068776 | Sleep Aids, Pharmaceutical |
| MeSH PA | D000068796 | Orexin Receptor Antagonists |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D006993 | Hypnotics and Sedatives |
| MeSH PA | D018377 | Neurotransmitter Agents |
| FDA MoA | N0000187064 | Cytochrome P450 2B6 Inducers |
| FDA MoA | N0000190998 | Orexin Receptor Antagonists |
| FDA EPC | N0000191000 | Orexin Receptor Antagonist |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
N05CJ Orexin receptor antagonists 2 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Insomnia | indication | 193462001 | |
| Narcolepsy | contraindication | 60380001 | DOID:8986 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.22 | acidic |
| pKa2 | 4.56 | Basic |
| pKa3 | 1.71 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | DAYVIGO | EISAI INC | N212028 | April 7, 2020 | RX | TABLET | ORAL | 8268848 | Sept. 20, 2031 | TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE |
| 5MG | DAYVIGO | EISAI INC | N212028 | April 7, 2020 | RX | TABLET | ORAL | 8268848 | Sept. 20, 2031 | TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE |
| 10MG | DAYVIGO | EISAI INC | N212028 | April 7, 2020 | RX | TABLET | ORAL | 10188652 | Oct. 21, 2035 | TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE |
| 5MG | DAYVIGO | EISAI INC | N212028 | April 7, 2020 | RX | TABLET | ORAL | 10188652 | Oct. 21, 2035 | TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | DAYVIGO | EISAI INC | N212028 | April 7, 2020 | RX | TABLET | ORAL | April 20, 2026 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E2006-A001-113 |
| 5MG | DAYVIGO | EISAI INC | N212028 | April 7, 2020 | RX | TABLET | ORAL | April 20, 2026 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E2006-A001-113 |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Orexin receptor type 1 | GPCR | ANTAGONIST | Ki | 8.22 | DRUG LABEL | DRUG LABEL | |||
| Orexin receptor type 2 | GPCR | ANTAGONIST | Ki | 8.52 | DRUG LABEL | DRUG LABEL | |||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 5.21 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4039370 | VANDF |
| CHEBI:755598 | CHEBI |
| CHEMBL3545367 | ChEMBL_ID |
| D11022 | KEGG_DRUG |
| C000634104 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9302 | IUPHAR_LIGAND_ID |
| DB11951 | DRUGBANK_ID |
| 838465007 | SNOMEDCT_US |
| 838492001 | SNOMEDCT_US |
| C4519269 | UMLSCUI |
| NRK | PDB_CHEM_ID |
| 9988 | INN_ID |
| 334297 | MMSL |
| 38462 | MMSL |
| d09561 | MMSL |
| 56944144 | PUBCHEM_CID |
| 018242 | NDDF |
| 0K5743G68X | UNII |
| 2272403 | RXNORM |
| 0K5743G68X | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| DAYVIGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-405 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 35 sections |
| DAYVIGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-410 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 35 sections |
| DAYVIGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-455 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 35 sections |