Sunosi
Sunosi Uses, Dosage, Side Effects, Food Interaction and all others data.
Sunosi 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 apnea. Sunosi was given FDA approval in 2019.
Sunosi weakly binds to dopamine and norepinephrine transporters but not serotonin transporters. Sunosi does not bind to dopamine, serotonin, norepinephrine, GABA, adenosine, histamine, orexin, benzodiazepines, or muscarinic and nicotinic receptors.
Sunosi 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). 300mg of solriamfetol does not increase the QTcF interval to a clinically relevant degree.
| Trade Name | Sunosi |
| Availability | Prescription only |
| Generic | Solriamfetol |
| Solriamfetol Other Names | Solriamfetol |
| Related Drugs | Adderall, methylphenidate, Concerta, modafinil, Ritalin, dextroamphetamine, armodafinil, Provigil, Nuvigil, Sunosi |
| Weight | 150mg, 75mg, |
| Type | Tablet, Oral Tablet |
| Formula | C10H14N2O2 |
| Weight | Average: 194.234 Monoisotopic: 194.105527699 |
| Protein binding | 13.3% to 19.4% protein bound over a plasma concentration range of 0.059 to 10.1mcg/mL. |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | Jazz Pharmaceuticals UK |
| Available Country | United Kingdom, United States, |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Sunosi 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 patients.
Sunosi is also used to associated treatment for these conditions: Daytime Sleepiness
How Sunosi works
The specific mechanism of action is unknown but it may be through its activity as a dopamine and norepinephrine reuptake inhibitor.
Toxicity
Age, gender, and race do not significantly affect solriamfetol pharmacokinetics and no dose adjustments were made in clinical trials for patients over 65 years.
Patients with renal failure experience increases in half life between 1.2 and 3.9 times that in healthy patients. 21% of solriamfetol was removed by hemodialysis, however time to peak concentration was not affected.
Sunosi is not expected to lead to adverse effects in pregnancy. 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 dose.
Breastfed infants should be monitored for adverse reactions such as agitation, insomnia, anorexia, and reduced weight gain as solriamfetol is present in breast milk. However, there is no currently available data on the effect of solriamfetol in breast milk on breast fed inants.
Safety and effectiveness of solriamfetol in pediatric patients has not been established in clinical studies.
Sunosi does not display different safety or effectiveness in geriatric populations.
Dosage adjustments are recommended for patients with eGFR Label.
Food Interaction
- Take with or without food.
Sunosi Drug Interaction
Moderate: amphetamine / dextroamphetamine, amphetamine / dextroamphetamine, apomorphine, carbidopa / levodopa, venlafaxineUnknown: zolpidem, testosterone, thyroid desiccated, trihexyphenidyl, hydroxyzine, onabotulinumtoxinA, clobetasol topical, rosuvastatin, cholecalciferol, lemborexant, tolterodine, dexlansoprazole, digoxin, estradiol, rivaroxaban
Sunosi Disease Interaction
Moderate: cardiovascular toxicities, psychiatric effects, renal dysfunction
Volume of Distribution
199L. Other studies have found the volume of distribution to be 158.2L ± 37.3L in fasted subjects and 159.8L ± 38.9L in fed subjects.
Elimination Route
Oral bioavailability of solriamfetol is approximately 95%. Peak plasma concentration is reached in 2 hours (with a range of 1.25 to 3 hours) in fasted patients. When solriamfetol is taken with a high fat meal, the time to peak plasma concentration increases to 3 hours.
Half Life
7.1 hours. 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 subjects.
Clearance
Renal clearance is 18.2L/h and total clearance is 19.5L/h. Other studies have found clearance to be 18.4 ± 4.2L/h in fasted subjects and 18.8 ± 4.2L/h in fed subjects.
Elimination Route
95% of solriamfetol is recovered in urine unchanged by metabolism. Less than 1% of solriamfetol is recovered as N-acetyl solriamfetol.
Innovators Monograph
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