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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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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
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
SUNOSIAxsome MaltaN-211230 RX2019-06-17
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
sunosiNew Drug Application2022-06-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sleepiness—D000077260R40.0
Agency Specific
FDA
EMA
Expiration
Code
SOLRIAMFETOL HYDROCHLORIDE, SUNOSI, AXSOME MALTA
2026-06-17ODE-254
2024-06-17NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Solriamfetol Hydrochloride, Sunosi, Axsome Malta
109401332040-03-19U-3099
111607792040-03-19U-3521
115603542039-03-06DPU-3520
109127542038-06-01U-3082
109599762038-06-01U-3151
116482322038-06-01U-3602
101951512037-09-05DP
105126092037-09-05U-2548
114395972037-09-05DP
84407152027-08-25U-2548
88778062026-06-07U-2548
96049172026-06-07U-2548
103515172026-06-07U-2548
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06B: Psychostimulants, agents used for adhd and nootropics
— N06BA: Centrally acting sympathomimetics
— N06BA14: Solriamfetol
HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obstructive sleep apneaD020181EFO_0003918G47.33—132—6
NarcolepsyD009290EFO_0000614G47.4—321—6
SleepinessD000077260R40.0—3—2—5
Circadian rhythm sleep disordersD020178G47.2———1—1
Chronic fatigue syndromeD015673EFO_0004540G93.31———1—1
Binge-eating disorderD056912F50.2———1—1
Postpartum periodD049590———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Attention deficit disorder with hyperactivityD001289EFO_0003888F90—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinson diseaseD010300EFO_0002508G20—1———1
Major depressive disorderD003865EFO_0003761F22—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSOLRIAMFETOL
INNsolriamfetol
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 classNorepinephrine–dopamine reuptake inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NC(=O)OC[C@H](N)Cc1ccccc1
Identifiers
PDB—
CAS-ID178429-62-4
RxCUI2121751
ChEMBL IDCHEMBL4297620
ChEBI ID—
PubChem CID10130337
DrugBankDB14754
UNII ID939U7C91AI (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
SLC6A3
SLC6A3
SLC6A2
SLC6A2
Organism
Homo sapiens
Gene name
SLC6A3
Gene synonyms
DAT1
NCBI Gene ID
6531
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
Q14996
Mouse ortholog
Slc6a3 (13162)
sodium-dependent dopamine transporter (Q9R1I2)
Variants
Clinical Variant
No data
Financial
Sunosi - Jazz Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 281 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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55,986 adverse events reported
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