Explore a selection of our essential drug information below, or:
Identification
- Brand Names
- Sunosi
- Generic Name
- Solriamfetol
- DrugBank Accession Number
- DB14754
- Background
Solriamfetol marketed under the brand name Sunosi by Jazz Pharmaceuticals in the United States is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated in treating daytime sleepiness associated with narcolepsy or obstructive sleep apneaLabel. Solriamfetol was given FDA approval in 2019Label.
- Type
- Small Molecule
- Groups
- Approved
- Structure
Structure for Solriamfetol (DB14754)
- Weight
- Average: 194.234
Monoisotopic: 194.105527699 - Chemical Formula
- C10H14N2O2
- Synonyms
- (2R)-2-amino-3-phenylpropyl carbamate
- Solriamfetol
- External IDs
- JZP-110
- R-228060
- SKL-N-05
- YKP-10A
Pharmacology
- Indication
Solriamfetol is indicated for treatment of daytime sleepiness associated with obstructive sleep apnea and narcolepsy, but is not a treatment for the underlying airway obstruction in apnea patientsLabel3,4.
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Daytime sleepiness •••••••••••• •••••• Treatment of Daytime sleepiness •••••••••••• •••••• - Contraindications & Blackbox Warnings
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Solriamfetol weakly binds to dopamine and norepinephrine transporters but not serotonin transportersLabel2. Solriamfetol does not bind to dopamine, serotonin, norepinephrine, GABA, adenosine, histamine, orexin, benzodiazepines, or muscarinic and nicotinic receptorsLabel.
Solriamfetol is also associated with a mean increase of 21 beats per minute (BPM) in heart rate in patients taking 300mg (twice the maximum recommended dose) and 27 BPM in patients taking 900mg (six times the maximum recommended dose)Label. 300mg of solriamfetol does not increase the QTcF interval to a clinically relevant degreeLabel.
- Mechanism of action
The specific mechanism of action is unknown but it may be through its activity as a dopamine and norepinephrine reuptake inhibitorLabel2.
Target Actions Organism USodium-dependent dopamine transporter Not Available Humans USodium-dependent noradrenaline transporter Not Available Humans - Absorption
Oral bioavailability of solriamfetol is approximately 95%Label. Peak plasma concentration is reached in 2 hours (with a range of 1.25 to 3 hours) in fasted patientsLabel. When solriamfetol is taken with a high fat meal, the time to peak plasma concentration increases to 3 hoursLabel.
- Volume of distribution
199LLabel. Other studies have found the volume of distribution to be 158.2L ± 37.3L in fasted subjects and 159.8L ± 38.9L in fed subjects4.
- Protein binding
13.3% to 19.4% protein bound over a plasma concentration range of 0.059 to 10.1mcg/mLLabel.
- Metabolism
Solriamfetol does not undergo significant metabolism in humans, though less than 1% of solriamfetol is metabolized to N-acetyl solriamfetolLabel2.
- Route of elimination
95% of solriamfetol is recovered in urine unchanged by metabolismLabel. Less than 1% of solriamfetol is recovered as N-acetyl solriamfetolLabel2.
- Half-life
7.1 hoursLabel. Other studies have found the mean half life to be 6.1 ± 1.2 hours in fasted subjects and 5.9 ± 1.2 hours in fed subjects4.
- Clearance
Renal clearance is 18.2L/h and total clearance is 19.5L/hLabel. Other studies have found clearance to be 18.4 ± 4.2L/h in fasted subjects and 18.8 ± 4.2L/h in fed subjects4.
- Adverse Effects
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Age, gender, and race do not significantly affect solriamfetol pharmacokinetics and no dose adjustments were made in clinical trials for patients over 65 yearsLabel.
Patients with renal failure experience increases in half life between 1.2 and 3.9 times that in healthy patientsLabel. 21% of solriamfetol was removed by hemodialysis, however time to peak concentration was not affectedLabel.
Solriamfetol is not expected to lead to adverse effects in pregnancyLabel. Maternal and fetal toxicity was seen in animal studies at ≥4 and 5 times the maximum recommended human dose and teratogenicity was seen at 19 and ≥5 times the maximum recommended human doseLabel.
Breastfed infants should be monitored for adverse reactions such as agitation, insomnia, anorexia, and reduced weight gain as solriamfetol is present in breast milkLabel. However, there is no currently available data on the effect of solriamfetol in breast milk on breast fed inantsLabel.
Safety and effectiveness of solriamfetol in pediatric patients has not been established in clinical studiesLabel.
Solriamfetol does not display different safety or effectiveness in geriatric populationsLabel.
Dosage adjustments are recommended for patients with eGFR <60mL/min/1.73m^2 and solriamfetol is not recommended for patients with an eGFR <15mL/min/1.73m^2Label.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your software1,2-Benzodiazepine The risk or severity of CNS depression can be increased when 1,2-Benzodiazepine is combined with Solriamfetol. Abacavir Abacavir may decrease the excretion rate of Solriamfetol which could result in a higher serum level. Abemaciclib The excretion of Abemaciclib can be decreased when combined with Solriamfetol. Acebutolol Solriamfetol may decrease the antihypertensive activities of Acebutolol. Aceclofenac The risk or severity of hypertension can be increased when Solriamfetol is combined with Aceclofenac. - Food Interactions
- Take with or without food.
Products
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Ingredient UNII CAS InChI Key Solriamfetol hydrochloride K7RO88SP7A 178429-65-7 KAOVAAHCFNYXNJ-SBSPUUFOSA-N - Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Sunosi Tablet, film coated 150 mg Oral Atnahs Pharma Netherlands B. V. 2020-12-16 Not applicable EU 
Sunosi Tablet, film coated 75 mg Oral Atnahs Pharma Netherlands B. V. 2020-12-16 Not applicable EU Sunosi Tablet, film coated 75 mg Oral Atnahs Pharma Netherlands B. V. 2020-12-16 Not applicable EU Sunosi Tablet, film coated 75 mg/1 Oral Axsome Therapeutics, Inc. 2019-06-18 Not applicable US 
Sunosi Tablet, film coated 150 mg/1 Oral Jazz Pharmaceuticals, Inc. 2019-06-18 2024-03-31 US
Categories
- ATC Codes
- N06BA14 — Solriamfetol
- Drug Categories
- Acids, Acyclic
- Adrenergic Agents
- Adrenergic Uptake Inhibitors
- Agents producing tachycardia
- Agents that produce hypertension
- Amino Acids
- Amino Acids, Aromatic
- Amino Acids, Cyclic
- Amino Acids, Peptides, and Proteins
- Antidepressive Agents
- Central Nervous System Agents
- Central Nervous System Depressants
- Centrally Acting Sympathomimetics
- Dopamine Agents
- Dopamine And Norepinephrine Reuptake Inhibitors
- Dopamine Uptake Inhibitors
- Drugs that are Mainly Renally Excreted
- MATE 1 Substrates
- MATE substrates
- Nervous System
- Norepinephrine Reuptake Inhibitor
- OCT2 Substrates
- Psychoanaleptics
- Psychostimulants, Agents Used for ADHD and Nootropics
- Wakefulness-Promoting Agents
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- 939U7C91AI
- CAS number
- 178429-62-4
- InChI Key
- UCTRAOBQFUDCSR-SECBINFHSA-N
- InChI
- InChI=1S/C10H14N2O2/c11-9(7-14-10(12)13)6-8-4-2-1-3-5-8/h1-5,9H,6-7,11H2,(H2,12,13)/t9-/m1/s1
- IUPAC Name
- (2R)-2-amino-3-phenylpropyl carbamate
- SMILES
- N[C@@H](COC(N)=O)CC1=CC=CC=C1
References
- General References
- Amsterdam JD, Brunswick DJ, Hundert M: A single-site, double-blind, placebo-controlled, dose-ranging study of YKP10A--a putative, new antidepressant. Prog Neuropsychopharmacol Biol Psychiatry. 2002 Dec;26(7-8):1333-8. [Article]
- Baladi MG, Forster MJ, Gatch MB, Mailman RB, Hyman DL, Carter LP, Janowsky A: Characterization of the Neurochemical and Behavioral Effects of Solriamfetol (JZP-110), a Selective Dopamine and Norepinephrine Reuptake Inhibitor. J Pharmacol Exp Ther. 2018 Aug;366(2):367-376. doi: 10.1124/jpet.118.248120. Epub 2018 Jun 11. [Article]
- Schweitzer PK, Rosenberg R, Zammit GK, Gotfried M, Chen D, Carter LP, Wang H, Lu Y, Black J, Malhotra A, Strohl KP: Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2018 Dec 6. doi: 10.1164/rccm.201806-1100OC. [Article]
- Zomorodi K, Kankam M, Lu Y: A Phase I, Randomized, Crossover, Open-label Study of the Pharmacokinetics of Solriamfetol (JZP-110) in Healthy Adult Subjects With and Without Food. Clin Ther. 2019 Feb;41(2):196-204. doi: 10.1016/j.clinthera.2018.12.001. Epub 2018 Dec 28. [Article]
- FDA Approved Drug Products: Sunosi Solriamfetol Oral Tablets [Link]
- External Links
- ChemSpider
- 8305853
- 2121751
- ChEMBL
- CHEMBL4297620
- ZINC
- ZINC000034278783
- Wikipedia
- Solriamfetol
- FDA label
- Download (700 KB)
- MSDS
- Download (52.2 KB)
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample data4 Active Not Recruiting Treatment Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) 1 somestatus stop reason just information to hide 4 Completed Treatment Excessive Daytime Sleepiness / Impaired Cognitive Function / Obstructive Sleep Apnea (OSA) 1 somestatus stop reason just information to hide 4 Recruiting Treatment Binge Eating Disorder (BED) 1 somestatus stop reason just information to hide 4 Recruiting Treatment Insomnia 1 somestatus stop reason just information to hide 4 Recruiting Treatment Shift-work related sleep disturbance / Somnolence 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Tablet Oral 150 mg Tablet Oral 75 mg Tablet, film coated Oral 150 mg/1 Tablet, film coated Oral 150 MG Tablet, film coated Oral 75 MG Tablet, film coated Oral 75 mg/1 - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US8877806 No 2014-11-04 2026-06-07 US US8440715 No 2013-05-14 2027-08-25 US US9604917 No 2017-03-28 2026-06-07 US US10195151 No 2019-02-05 2037-09-05 US US10351517 No 2019-07-16 2026-06-07 US US10512609 No 2019-12-24 2037-09-05 US US10912754 No 2021-02-09 2038-06-01 US US10940133 No 2021-03-09 2040-03-19 US US10959976 No 2021-03-30 2038-06-01 US US11439597 No 2014-11-05 2034-11-05 US US11560354 No 2019-03-06 2039-03-06 US US11160779 No 2021-11-02 2040-03-19 US US11648232 No 2018-06-01 2038-06-01 US US11753368 No 2006-06-07 2026-06-07 US US11771667 No 2022-12-30 2042-12-30 US US11771666 No 2022-12-30 2042-12-30 US US11793776 No 2022-12-30 2042-12-30 US US11779554 No 2022-12-30 2042-12-30 US US11839599 No 2020-03-19 2040-03-19 US US11839598 No 2020-03-19 2040-03-19 US US11850226 No 2020-03-19 2040-03-19 US US11850227 No 2020-03-19 2040-03-19 US US11850228 No 2020-03-19 2040-03-19 US US11857528 No 2020-03-19 2040-03-19 US US11872203 No 2022-12-30 2042-12-30 US US11872204 No 2022-12-30 2042-12-30 US US11865098 No 2018-06-01 2038-06-01 US US11969404 No 2020-03-19 2040-03-19 US US11998639 No 2017-09-05 2037-09-05 US US11986455 No 2020-03-19 2040-03-19 US US11986454 No 2020-03-19 2040-03-19 US US12005036 No 2022-12-30 2042-12-30 US
Properties
- State
- Not Available
- Experimental Properties
- Not Available
- Predicted Properties
Property Value Source Water Solubility 1.95 mg/mL ALOGPS logP 0.62 ALOGPS logP 0.86 Chemaxon logS -2 ALOGPS pKa (Strongest Acidic) 15.68 Chemaxon pKa (Strongest Basic) 9.08 Chemaxon Physiological Charge 1 Chemaxon Hydrogen Acceptor Count 2 Chemaxon Hydrogen Donor Count 2 Chemaxon Polar Surface Area 78.34 Å2 Chemaxon Rotatable Bond Count 5 Chemaxon Refractivity 53.08 m3·mol-1 Chemaxon Polarizability 20.64 Å3 Chemaxon Number of Rings 1 Chemaxon Bioavailability 1 Chemaxon Rule of Five Yes Chemaxon Ghose Filter Yes Chemaxon Veber's Rule No Chemaxon MDDR-like Rule No Chemaxon - Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
Spectrum Spectrum Type Splash Key Predicted MS/MS Spectrum - 10V, Positive (Annotated) Predicted LC-MS/MS splash10-0159-1900000000-c41194fa6f6bc0bc7e62 Predicted MS/MS Spectrum - 10V, Negative (Annotated) Predicted LC-MS/MS splash10-000x-9800000000-ede5783378c4a616bcd2 Predicted MS/MS Spectrum - 20V, Negative (Annotated) Predicted LC-MS/MS splash10-0006-9000000000-af9869988c8dbe7045bd Predicted MS/MS Spectrum - 20V, Positive (Annotated) Predicted LC-MS/MS splash10-0fr6-5900000000-b5750ee520d020dbe87b Predicted MS/MS Spectrum - 40V, Negative (Annotated) Predicted LC-MS/MS splash10-0006-9300000000-f505b96c8664b77aeeae Predicted MS/MS Spectrum - 40V, Positive (Annotated) Predicted LC-MS/MS splash10-0006-9400000000-5a71dba5429501a07207 Predicted 1H NMR Spectrum 1D NMR Not Applicable Predicted 13C NMR Spectrum 1D NMR Not Applicable - Chromatographic Properties
Collision Cross Sections (CCS)
Not Available
Targets
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- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Mediates sodium- and chloride-dependent transport of dopamine (PubMed:10375632, PubMed:11093780, PubMed:1406597, PubMed:15505207, PubMed:19478460, PubMed:8302271). Also mediates sodium- and chloride-dependent transport of norepinephrine (also known as noradrenaline) (By similarity). Regulator of light-dependent retinal hyaloid vessel regression, downstream of OPN5 signaling (By similarity)
- Specific Function
- Amine binding
- Gene Name
- SLC6A3
- Uniprot ID
- Q01959
- Uniprot Name
- Sodium-dependent dopamine transporter
- Molecular Weight
- 68494.255 Da
References
- Baladi MG, Forster MJ, Gatch MB, Mailman RB, Hyman DL, Carter LP, Janowsky A: Characterization of the Neurochemical and Behavioral Effects of Solriamfetol (JZP-110), a Selective Dopamine and Norepinephrine Reuptake Inhibitor. J Pharmacol Exp Ther. 2018 Aug;366(2):367-376. doi: 10.1124/jpet.118.248120. Epub 2018 Jun 11. [Article]
- Solriamfetol FDA Label [File]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Mediates sodium- and chloride-dependent transport of norepinephrine (also known as noradrenaline) (PubMed:2008212, PubMed:8125921). Can also mediate sodium- and chloride-dependent transport of dopamine (PubMed:11093780, PubMed:8125921)
- Specific Function
- Actin binding
- Gene Name
- SLC6A2
- Uniprot ID
- P23975
- Uniprot Name
- Sodium-dependent noradrenaline transporter
- Molecular Weight
- 69331.42 Da
References
- Baladi MG, Forster MJ, Gatch MB, Mailman RB, Hyman DL, Carter LP, Janowsky A: Characterization of the Neurochemical and Behavioral Effects of Solriamfetol (JZP-110), a Selective Dopamine and Norepinephrine Reuptake Inhibitor. J Pharmacol Exp Ther. 2018 Aug;366(2):367-376. doi: 10.1124/jpet.118.248120. Epub 2018 Jun 11. [Article]
- Solriamfetol FDA Label [File]
Transporters
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Electrogenic voltage-dependent transporter that mediates the transport of a variety of organic cations such as endogenous bioactive amines, cationic drugs and xenobiotics (PubMed:9260930, PubMed:9687576). Functions as a Na(+)-independent, bidirectional uniporter (PubMed:21128598, PubMed:9687576). Cation cellular uptake or release is driven by the electrochemical potential, i.e. membrane potential and concentration gradient (PubMed:15212162, PubMed:9260930, PubMed:9687576). However, may also engage electroneutral cation exchange when saturating concentrations of cation substrates are reached (By similarity). Predominantly expressed at the basolateral membrane of hepatocytes and proximal tubules and involved in the uptake and disposition of cationic compounds by hepatic and renal clearance from the blood flow (PubMed:15783073). Implicated in monoamine neurotransmitters uptake such as histamine, dopamine, adrenaline/epinephrine, noradrenaline/norepinephrine, serotonin and tyramine, thereby supporting a physiological role in the central nervous system by regulating interstitial concentrations of neurotransmitters (PubMed:16581093, PubMed:17460754, PubMed:9687576). Also capable of transporting dopaminergic neuromodulators cyclo(his-pro), salsolinol and N-methyl-salsolinol, thereby involved in the maintenance of dopaminergic cell integrity in the central nervous system (PubMed:17460754). Mediates the bidirectional transport of acetylcholine (ACh) at the apical membrane of ciliated cell in airway epithelium, thereby playing a role in luminal release of ACh from bronchial epithelium (PubMed:15817714). Also transports guanidine and endogenous monoamines such as vitamin B1/thiamine, creatinine and N-1-methylnicotinamide (NMN) (PubMed:12089365, PubMed:15212162, PubMed:17072098, PubMed:24961373, PubMed:9260930). Mediates the uptake and efflux of quaternary ammonium compound choline (PubMed:9260930). Mediates the bidirectional transport of polyamine agmatine and the uptake of polyamines putrescine and spermidine (PubMed:12538837, PubMed:21128598). Able to transport non-amine endogenous compounds such as prostaglandin E2 (PGE2) and prostaglandin F2-alpha (PGF2-alpha) (PubMed:11907186). Also involved in the uptake of xenobiotic 4-(4-(dimethylamino)styryl)-N-methylpyridinium (ASP) (PubMed:12395288, PubMed:16394027). May contribute to regulate the transport of organic compounds in testis across the blood-testis-barrier (Probable)
- Specific Function
- Acetylcholine transmembrane transporter activity
- Gene Name
- SLC22A2
- Uniprot ID
- O15244
- Uniprot Name
- Solute carrier family 22 member 2
- Molecular Weight
- 62579.99 Da
References
- Solriamfetol FDA Label [File]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Transporter that mediates the transport of endogenous and microbial zwitterions and organic cations (PubMed:10215651, PubMed:15107849, PubMed:15795384, PubMed:16729965, PubMed:20601551, PubMed:22206629, PubMed:22569296, PubMed:29530864). Functions as a Na(+)-dependent and pH-dependent high affinity microbial symporter of potent food-derived antioxidant ergothioeine (PubMed:15795384, PubMed:29530864, PubMed:33124720). Transports one sodium ion with one ergothioeine molecule (By similarity). Involved in the absorption of ergothioneine from the luminal/apical side of the small intestine and renal tubular cells, and into non-parenchymal liver cells, thereby contributing to maintain steady-state ergothioneine level in the body (PubMed:20601551). Also mediates the bidirectional transport of acetycholine, although the exact transport mechanism has not been fully identified yet (PubMed:22206629). Most likely exports anti-inflammatory acetylcholine in non-neuronal tissues, thereby contributing to the non-neuronal cholinergic system (PubMed:22206629, PubMed:22569296). Displays a general physiological role linked to better survival by controlling inflammation and oxidative stress, which may be related to ergothioneine and acetycholine transports (PubMed:15795384, PubMed:22206629). May also function as a low-affinity Na(+)-dependent transporter of L-carnitine through the mitochondrial membrane, thereby maintaining intracellular carnitine homeostasis (PubMed:10215651, PubMed:15107849, PubMed:16729965). May contribute to regulate the transport of cationic compounds in testis across the blood-testis-barrier (PubMed:35307651)
- Specific Function
- Acetylcholine transmembrane transporter activity
- Gene Name
- SLC22A4
- Uniprot ID
- Q9H015
- Uniprot Name
- Solute carrier family 22 member 4
- Molecular Weight
- 62154.48 Da
References
- Solriamfetol FDA Label [File]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Sodium-ion dependent, high affinity carnitine transporter. Involved in the active cellular uptake of carnitine. Transports one sodium ion with one molecule of carnitine (PubMed:10454528, PubMed:10525100, PubMed:10966938, PubMed:17509700, PubMed:20722056, PubMed:33124720). Also transports organic cations such as tetraethylammonium (TEA) without the involvement of sodium. Relative uptake activity ratio of carnitine to TEA is 11.3 (PubMed:10454528, PubMed:10525100, PubMed:10966938). In intestinal epithelia, transports the quorum-sensing pentapeptide CSF (competence and sporulation factor) from Bacillus Subtilis wich induces cytoprotective heat shock proteins contributing to intestinal homeostasis (PubMed:18005709). May also contribute to regulate the transport of organic compounds in testis across the blood-testis-barrier (Probable)
- Specific Function
- (r)-carnitine transmembrane transporter activity
- Gene Name
- SLC22A5
- Uniprot ID
- O76082
- Uniprot Name
- Organic cation/carnitine transporter 2
- Molecular Weight
- 62751.08 Da
References
- Solriamfetol FDA Label [File]
Drug created at March 29, 2019 21:28 / Updated at August 31, 2022 19:25