Sunosi (solriamfetol HCl)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Solriamfetol hydrochloride, a dopamine- and norepinephrine-reuptake inhibitor (DNRI), is a wakefulness-promoting agent.
Solriamfetol, a derivative of the amino acid phenylalanine, is a dopamine- and norepinephrine-reuptake inhibitor (DNRI). Solriamfetol binds to dopamine and norepinephrine transporters with low affinity and inhibits the reuptake of dopamine and norepinephrine with low potency. Solriamfetol has no appreciable binding affinity for serotonin transporter and does not inhibit serotonin reuptake.
Solriamfetol also has no appreciable binding affinity for dopamine, serotonin, norepinephrine, gamma-aminobutyric acid (GABA), adenosine, histamine, orexin, benzodiazepine, muscarinic acetylcholine, or nicotinic acetylcholine receptors. The exact mechanism by which solriamfetol promotes wakefulness in patients with excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy is not known but may involve inhibition of dopamine and norepinephrine reuptake resulting from binding of the drug to dopamine and norepinephrine transporters in the brainstem arousal systems.
Solriamfetol exhibits linear pharmacokinetics over a dose range of 42-1008 mg; once-daily administration is expected to result in minimal accumulation. Solriamfetol is readily (95%) absorbed following oral administration. Following oral administration under fasted conditions, peak plasma concentration is achieved at a median of 2 hours (range: 1.25-3 hours).
Administration with a high-fat meal delays the peak plasma concentration by approximately 1 hour, but results in minimal change in overall exposure (peak concentration or area under the plasma concentration-time curve (AUC)). Solriamfetol is approximately 13-19% bound to plasma proteins. The drug exhibits first-order elimination, with a mean apparent elimination half-life of about 7.1 hours.
Solriamfetol is eliminated mainly (95%) in urine as unchanged drug; 1% or less of an administered dose is recovered as the minor inactive metabolite N-acetylsolriamfetol. Active tubular secretion is likely involved in renal clearance of the parent drug. Age, sex, and race do not have clinically important effects on the pharmacokinetics of solriamfetol.
USES: This medication is used to improve wakefulness in people that have too much daytime sleepiness due to certain sleep problems (narcolepsy, obstructive sleep apnea). It may work by changing the amounts of certain substances (dopamine, norepinephrine) in your body. This medication is not used to treat the cause of obstructive sleep apnea-OSA.
Continue treatment for OSA, such as using continuous positive airway pressure (CPAP), while using this medication.
Generic name: solriamfetol HCl
Pronunciation: (SOL-ri-AM-fe-tol)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Sunosi
Indications
The following indications are listed for Sunosi:
- Narcolepsy Syndrome
- Sleepiness Due To Obstructive Sleep Apnea
Also known as: Excessive Sleepiness Associated With Osahs, Friedmann's Disease, Gelineau's Syndrome, Hypnolepsy, Narcolepsy, Paroxysmal Sleep, Sleepiness Associated With Hypopnea Syndrome, Sleepiness Associated With Obstructive Sleep Apnea, Somnolence From Obstructive Sleep Apnea.
Dosing
Dosage of solriamfetol hydrochloride is expressed in terms of solriamfetol.
In patients with obstructive sleep apnea or narcolepsy, solriamfetol is administered orally once daily upon awakening; the drug may be administered without regard to food. Administration within 9 hours of planned bedtime should be avoided because of the potential for interference with sleep.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Solriamfetol is contraindicated in patients who are currently receiving or have recently (within 14 days) received therapy with a monoamine oxidase (MAO) inhibitor. (See Cardiovascular Effects under Cautions: Warnings/Precautions and also see Drug Interactions: Monoamine Oxidase Inhibitors.)
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in clinical trials in 5% of more of patients receiving solriamfetol and more frequently with the drug than with placebo include headache, nausea, decreased appetite, insomnia, and anxiety. In clinical trials, headache, nausea, decreased appetite, anxiety, diarrhea, and dry mouth were dose related.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of solriamfetol in pediatric patients have not been established.
Available data from case reports are insufficient to determine solriamfetol-associated risks of major birth defects, spontaneous abortion, or adverse maternal or fetal outcomes.
Teratogenicity, fetal toxicity, and developmental toxicity have been observed in animal studies. In reproduction studies in rats, maternal toxicity (hyperactivity, decreased body weight, reduced weight gain, reduced food consumption) and fetal toxicity (resorption, post-implantation loss, decreased fetal weight) were observed at dosages of 4 or more times the maximum recommended human dose (MRHD); fetal malformations (sternebrae malalignment, hindlimb rotation, bent limb bones, situs inversu) were observed at dosages of 19 times the MRHD. In reproduction studies in rabbits, maternal toxicity was observed at dosages of 10 times the MRHD and fetal malformations (sternebrae malalignment) and toxicity (decreased fetal weight) were observed at dosages of 5 or more times the MRHD. Administration to rats during pregnancy and lactation at dosages of 7 or more times the MRHD resulted in maternal toxicity and adverse effects on fertility, growth, and development in the offspring.
The manufacturer has established a pregnancy registry to monitor fetal outcomes of pregnant women exposed to solriamfetol. Clinicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry, by calling 877-283-6220 or visiting http://www.SunosiPregnancyRegistry.com.
It is not known whether solriamfetol or its metabolites are distributed into human milk, affect breast-fed infants, or affect milk production. Solriamfetol is distributed into milk in rats. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for solriamfetol and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition. Nursing infants should be monitored for adverse effects (e.g., agitation, insomnia, anorexia, reduced weight gain) potentially resulting from exposure to the drug through breast milk.
Of the total number of patients with obstructive sleep apnea or narcolepsy receiving solriamfetol in clinical trials, 13% were 65 years of age or older. No clinically important differences in safety or efficacy were observed between geriatric patients and younger adults.
Population pharmacokinetic analysis indicates that age does not have a clinically important effect on the pharmacokinetics of solriamfetol, and no dosage adjustments were made in clinical trials that included patients 65 of age or older. However, because geriatric patients are more likely to have decreased renal function and solriamfetol is eliminated mainly by the kidneys, dosage adjustment may be necessary; consideration should be given to the use of lower dosages and close monitoring in this population. (See Dosage and Administration: Special Populations.)
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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