Sunosi(solriamfetol)
Sunosi (solriamfetol) is a small molecule pharmaceutical. Solriamfetol was first approved as Sunosi on 2019-06-17. It is used to treat sleepiness in the USA. It has been approved in Europe to treat narcolepsy and obstructive sleep apnea. It is known to target sodium-dependent dopamine transporter and sodium-dependent noradrenaline transporter.
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Commercial
Trade Name
FDA
EMA
Sunosi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Solriamfetol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUNOSI | Axsome Malta | N-211230 RX | 2019-06-17 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sunosi | New Drug Application | 2023-07-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| sleepiness | — | D000077260 | R40.0 |
| obstructive sleep apnea | EFO_0003918 | D020181 | G47.33 |
| narcolepsy | HP_0030050 | D009290 | G47.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SOLRIAMFETOL HYDROCHLORIDE, SUNOSI, AXSOME MALTA | |||
| 2026-06-17 | ODE-254 | ||
| 2024-06-17 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Solriamfetol Hydrochloride, Sunosi, Axsome Malta | |||
| 11771666 | 2042-12-30 | U-3693 | |
| 11771667 | 2042-12-30 | U-3693 | |
| 11779554 | 2042-12-30 | U-3693 | |
| 11793776 | 2042-12-30 | U-3693 | |
| 11872203 | 2042-12-30 | U-3693 | |
| 11872204 | 2042-12-30 | U-3693 | |
| 10940133 | 2040-03-19 | U-3099 | |
| 11160779 | 2040-03-19 | U-3521 | |
| 11839598 | 2040-03-19 | U-3765 | |
| 11839599 | 2040-03-19 | U-3764 | |
| 11850226 | 2040-03-19 | U-3775 | |
| 11850227 | 2040-03-19 | U-3775 | |
| 11850228 | 2040-03-19 | U-3775 | |
| 11857528 | 2040-03-19 | U-3521 | |
| 11560354 | 2039-03-06 | DP | U-3520 |
| 10912754 | 2038-06-01 | U-3082 | |
| 10959976 | 2038-06-01 | U-3151 | |
| 11648232 | 2038-06-01 | U-3602 | |
| 11865098 | 2038-06-01 | U-2548 | |
| 10195151 | 2037-09-05 | DP | |
| 10512609 | 2037-09-05 | U-2548 | |
| 11439597 | 2037-09-05 | DP | |
| 8440715 | 2031-06-11 | U-2548 | |
| 8877806 | 2026-06-07 | U-2548 | |
| 9604917 | 2026-06-07 | U-2548 | |
| 10351517 | 2026-06-07 | U-2548 | |
| 11753368 | 2026-06-07 | U-2548 | |
HCPCS
No data
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleepiness | D000077260 | — | R40.0 | 1 | 5 | 6 | 2 | — | 14 |
| Disorders of excessive somnolence | D006970 | — | G47.1 | 1 | 8 | 2 | 2 | — | 13 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 1 | 1 | 4 | 1 | 1 | 8 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | — | 1 | 4 | 1 | 1 | 7 |
| Apnea | D001049 | HP_0002104 | R06.81 | — | — | 1 | 1 | — | 2 |
| Circadian rhythm sleep disorders | D020178 | — | G47.2 | — | — | 1 | 1 | — | 2 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | 1 | — | 1 | — | 2 |
| Bulimia | D002032 | — | F50.2 | — | — | 1 | 1 | — | 2 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | 1 | 1 | — | 2 |
| Binge-eating disorder | D056912 | — | F50.2 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Narcolepsy | D009290 | HP_0030050 | G47.4 | 1 | 3 | 2 | — | 2 | 8 |
| Depression | D003863 | — | F33.9 | — | 1 | 1 | — | — | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | 1 | — | — | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | 1 | — | — | 2 |
| Hyperkinesis | D006948 | HP_0000752 | — | — | 1 | 1 | — | — | 1 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-acute covid-19 syndrome | D000094024 | — | — | — | 2 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 1 | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | — | 1 | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | — | 1 |
| Sclerosis | D012598 | — | — | — | 1 | — | — | — | 1 |
| Sleep wake disorders | D012893 | — | G47 | — | 1 | — | — | — | 1 |
| Dyssomnias | D020920 | — | — | — | 1 | — | — | — | 1 |
| Parasomnias | D020447 | — | G47.5 | — | 1 | — | — | — | 1 |
| Idiopathic hypersomnia | D020177 | — | G47.11 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postpartum period | D049590 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Solriamfetol |
| INN | solriamfetol |
| Description | Solriamfetol, sold under the brand name Sunosi, is a wakefulness-promoting medication used in the treatment of excessive sleepiness related to narcolepsy and sleep apnea. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | Norepinephrine–dopamine reuptake inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)OC[C@H](N)Cc1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 178429-62-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297620 |
| ChEBI ID | — |
| PubChem CID | 10130337 |
| DrugBank | DB14754 |
| UNII ID | 939U7C91AI (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SLC6A3
SLC6A3
SLC6A2
SLC6A2
Organism
Homo sapiens
Gene name
SLC6A3
Gene synonyms
DAT1
NCBI Gene ID
Protein name
sodium-dependent dopamine transporter
Protein synonyms
DA transporter, dopamine transporter 1, solute carrier family 6 (neurotransmitter transporter), member 3, solute carrier family 6 (neurotransmitter transporter, dopamine), member 3, Solute carrier family 6 member 3
Uniprot ID
Mouse ortholog
Slc6a3 (13162)
sodium-dependent dopamine transporter (Q9R1I2)
Variants
No data
Financial
Revenue by drug
$
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£
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Sunosi – Jazz Pharmaceuticals
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 336 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,673 adverse events reported
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