solriamfetol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5325 | 178429-62-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, solriamfetol binds to the dopamine transporter and norepinephrine transporter with low affinity and inhibits the reuptake of dopamine and norepinephrine with low potency. Solriamfetol has no appreciable binding affinity for the serotonin transporter (Ki=81.5 μM) and does not inhibit serotonin reuptake (IC50 > 100 μM). Solriamfetol improves wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 16, 2020 | EMA | Jazz Pharmaceuticals Ireland Limited | |
| March 20, 2019 | FDA | JAZZ |
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 |
|---|---|---|---|---|---|---|
| Anxiety | 54.04 | 46.53 | 33 | 709 | 177573 | 50426809 |
| Sleep apnoea syndrome | 49.55 | 46.53 | 17 | 725 | 23851 | 50580531 |
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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 62.42 | 58.39 | 33 | 141 | 363137 | 29211216 |
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N06BA14 | NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Narcolepsy | indication | 60380001 | DOID:8986 |
| Obstructive sleep apnea syndrome | indication | 78275009 | DOID:0050848 |
| Excessive daytime sleepiness - normal night sleep | indication | 230489007 | |
| Monoamine oxidase inhibitor | contraindication | 734595009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.22 | acidic |
| pKa2 | 7.89 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | 10351517 | June 7, 2026 | TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) |
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | 8877806 | June 7, 2026 | TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) |
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | 9604917 | June 7, 2026 | TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) |
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | 8440715 | Aug. 25, 2027 | TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) |
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | 10512609 | Sept. 5, 2037 | TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) |
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | 10912754 | June 1, 2038 | TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN AN ADULT THROUGH A DOSING REGIMEN THAT INCLUDES ORAL ADMINISTRATION OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY |
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | 10959976 | June 1, 2038 | TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) WITH A DOSING REGIMEN THAT INCLUDES A DOSE OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY |
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | 10940133 | March 19, 2040 | TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN A PATIENT WITH MODERATE RENAL IMPAIRMENT |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | June 17, 2024 | NEW CHEMICAL ENTITY |
| EQ 75MG BASE | SUNOSI | AXSOME MALTA | N211230 | June 17, 2019 | RX | TABLET | ORAL | June 17, 2026 | INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sodium-dependent dopamine transporter | Transporter | INHIBITOR | Ki | 4.85 | DRUG LABEL | ||||
| Sodium-dependent serotonin transporter | Transporter | INHIBITOR | Ki | 4.09 | DRUG LABEL | ||||
| Sodium-dependent noradrenaline transporter | Transporter | INHIBITOR | Ki | 5.43 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 939U7C91AI | UNII |
| C4726765 | UMLSCUI |
| CHEMBL4297212 | ChEMBL_ID |
| CHEMBL4297620 | ChEMBL_ID |
| 10130337 | PUBCHEM_CID |
| DB14754 | DRUGBANK_ID |
| D11315 | KEGG_DRUG |
| 10342 | IUPHAR_LIGAND_ID |
| 2121751 | RXNORM |
| 319330 | MMSL |
| d09320 | MMSL |
| 787053002 | SNOMEDCT_US |
| 787070005 | SNOMEDCT_US |
| 4038551 | VANDF |
| 017938 | NDDF |
| C000623308 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10117 | INN_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SUNOSI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-350 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 26 sections |
| SUNOSI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-350 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 26 sections |
| SUNOSI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-351 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 26 sections |
| SUNOSI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-351 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 26 sections |
| SUNOSI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81968-350 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 31 sections |
| SUNOSI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81968-351 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 31 sections |