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
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
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 Browse all" title="About SNP Mediated Effects/ADRs" id="snp-actions-info" class="drug-info-popup" href="javascript:void(0);">
- Not Available
Interactions
- Drug Interactions Learn More" title="About Drug Interactions" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">
- 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
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Product Ingredients
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 150 mg Oral Axsome Malta Ltd. 2021-08-03 Not applicable Canada 
Sunosi Tablet, film coated 75 mg/1 Oral Jazz Pharmaceuticals, Inc. 2019-06-18 2025-10-31 US 
Sunosi Tablet, film coated 75 mg Oral Tmc Pharma (Eu) Limited 2020-12-16 Not applicable EU 
Sunosi Tablet, film coated 150 mg/1 Oral Axsome Therapeutics, Inc. 2019-06-18 Not applicable US Sunosi Tablet, film coated 150 mg Oral Tmc Pharma (Eu) Limited 2020-12-16 Not applicable EU
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 Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">
Phase Status Purpose Conditions Count 4 Active Not Recruiting Treatment Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) 1 4 Completed Treatment Excessive Daytime Sleepiness / Impaired Cognitive Function / Obstructive Sleep Apnea (OSA) 1 4 Recruiting Treatment Binge Eating Disorder (BED) 1 4 Recruiting Treatment Insomnia 1 4 Recruiting Treatment Shift-work related sleep disturbance / Somnolence 1
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
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
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Monoamine transmembrane transporter activity
- Specific Function
- Amine transporter. Terminates the action of dopamine by its high affinity sodium-dependent reuptake into presynaptic terminals.
- 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
- Norepinephrine:sodium symporter activity
- Specific Function
- Amine transporter. Terminates the action of noradrenaline by its high affinity sodium-dependent reuptake into presynaptic terminals.
- 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
- Quaternary ammonium group transmembrane transporter activity
- Specific Function
- Mediates tubular uptake of organic compounds from circulation. Mediates the influx of agmatine, dopamine, noradrenaline (norepinephrine), serotonin, choline, famotidine, ranitidine, histamin, creat...
- 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
- Symporter activity
- Specific Function
- Sodium-ion dependent, low affinity carnitine transporter. Probably transports one sodium ion with one molecule of carnitine. Also transports organic cations such as tetraethylammonium (TEA) without...
- 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
- Symporter activity
- Specific 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. Also transports organic cat...
- Gene Name
- SLC22A5
- Uniprot ID
- O76082
- Uniprot Name
- Solute carrier family 22 member 5
- 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