Version May 2024
Narcolepsy: Oral: Initial: 75 mg once daily; may increase based on response and tolerability at an interval of ≥3 days to the maximum dose of 150 mg/day.
Obstructive sleep apnea: Oral: Initial: 37.5 mg once daily; based on response and tolerability may double the dose at intervals of ≥3 days up to the maximum dose of 150 mg/day.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
eGFR 30 to 59 mL/minute/1.73 m2: Initial: 37.5 mg once daily; may increase based on response and tolerability at intervals ≥7 days to the maximum dose of 75 mg/day.
eGFR 15 to 29 mL/minute/1.73 m2: 37.5 mg once daily (maximum: 37.5 mg/day).
eGFR <15 mL/minute/1.73 m2: Use is not recommended.
Hemodialysis: Dialyzable (21%).
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is not likely to be necessary (hepatic metabolism is minimal).
Refer to adult dosing; consider use of lower doses.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%: Nervous system: Headache (16%)
1% to 10%:
Cardiovascular: Chest discomfort (≤2%), chest pain (<2%), palpitations (2% to 3%)
Dermatologic: Hyperhidrosis (≤2%)
Endocrine & metabolic: Increased thirst (<2%), weight loss (<2%)
Gastrointestinal: Abdominal pain (3%), bruxism (<2%), constipation (≤3%), decreased appetite (6% to 9%), diarrhea (4%), nausea (7% to 8%), vomiting (<2%), xerostomia (3% to 4%)
Nervous system: Agitation (<2%), anxiety (4% to 6%), disturbance in attention (<2%), dizziness (2%), insomnia (5%), irritability (≤3%), jitteriness (≤3%), restlessness (<2%)
Neuromuscular & skeletal: Tremor (<2%)
Respiratory: Cough (<2%), dyspnea (<2%)
Frequency not defined: Cardiovascular: Increased diastolic blood pressure, increased heart rate, increased systolic blood pressure
Postmarketing: Hypersensitivity: Hypersensitivity reaction
Concomitant use with or within 14 days of a monoamine oxidase inhibitor.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to solriamfetol or any component of the formulation; recent myocardial infarction (within 1 year); unstable angina; hypertension (uncontrolled); serious cardia arrhythmias; other serious heart problems; end-stage renal disease.
Concerns related to adverse effects:
• Cardiovascular effects: May cause dose-dependent increases in blood pressure and heart rate. Monitor heart rate and blood pressure prior to and regularly during treatment; control hypertension prior to initiating and during treatment. Avoid use in patients with unstable cardiovascular disease, serious heart arrhythmias, or other serious heart problems. Use caution in patients at high risk for cardiovascular events (eg, patients with known cardiovascular or cerebrovascular disease, preexisting hypertension, advanced age). If increases in blood pressure or heart rate cannot be managed with dose reduction of solriamfetol or other appropriate medical interventions, consider discontinuation of solriamfetol.
• Psychiatric effects: Psychiatric symptoms including anxiety, insomnia, and irritability have been reported with use. Use cautiously in patients with a history of psychosis or bipolar disorders; solriamfetol has not been studied with these populations. Monitor patients for emergence or exacerbation of psychiatric symptoms; if psychiatric symptoms develop reduce dose or discontinue.
Disease-related concerns:
• Substance abuse: Solriamfetol may have potential for abuse. Carefully evaluate patients for a recent history of drug abuse, especially stimulant or alcohol abuse, and monitor closely for signs of misuse or abuse.
Special populations:
• Renal impairment: Use with caution in patients with renal impairment; dose adjustment required. Patients with moderate or severe renal impairment may be at higher risk of increased blood pressure, heart rate, and psychiatric symptoms due to the prolonged half-life in this population.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Sunosi: 75 mg [scored]
Sunosi: 150 mg
No
Tablets (Sunosi Oral)
75 mg (per each): $34.89
150 mg (per each): $34.89
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Sunosi: 75 mg, 150 mg
C-IV
Oral: Administer once daily upon awakening. Avoid administration within 9 hours of planned bedtime because of the potential to interfere with sleep.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Sunosi: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211230s009lbl.pdf#page=23
Narcolepsy or obstructive sleep apnea: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
Limitations of use: Solriamfetol is not indicated to treat the underlying airway obstruction in OSA. Patients should be treated for underlying airway obstruction for at least 1 month prior to and during therapy.
Solriamfetol may be confused with solifFENacin.
Substrate of OCT2
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Anti-Parkinson Agents (Dopamine Agonist): Solriamfetol may enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Risk C: Monitor therapy
CNS Stimulants: May enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Herbal Products with Blood Pressure Increasing Effects: Solriamfetol may enhance the hypertensive effect of Herbal Products with Blood Pressure Increasing Effects. Risk C: Monitor therapy
Hypertension-Associated Agents: Solriamfetol may enhance the hypertensive effect of Hypertension-Associated Agents. Risk C: Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Solriamfetol. Risk X: Avoid combination
Sympathomimetics: May enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Adverse maternal and fetal events were observed in animal reproduction studies.
Data collection to monitor pregnancy and infant outcomes following exposure to solriamfetol is ongoing. Health care providers are encouraged to enroll patients exposed to solriamfetol during pregnancy in the Sunosi Pregnancy Registry (877-283-6220 or www.SunosiPregnancyRegistry.com). Patients may also enroll themselves.
Solriamfetol is present in breast milk.
Data related to the presence of solriamfetol in breast milk are available following a single 150 mg dose administered to 6 healthy lactating patients, 10 days to 52 weeks postpartum. The manufacturer reports the cumulative median concentration of solriamfetol excreted in breast milk over 72 hours was 0.67 mg, or ~5.5% of the weight adjusted maternal dose. The mean elimination half-life of solriamfetol in breast milk was calculated to be ~5 hours, with 78% excreted by 8 hours, and 98% excreted by 24 hours after the maternal dose. The estimated daily infant dose via breast milk was calculated to be 0.112 mg/kg/day providing a relative infant dose (RID) of 5.5% compared to the weight-adjusted maternal dose.
In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000). However, some sources note breastfeeding should only be considered if the RID is <5% for psychotropic agents (Larsen 2015).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Exposed infants should be monitored for adverse events such as agitation, anorexia, insomnia, and reduced weight gain.
Blood pressure and heart rate (baseline and regularly during treatment)
The mechanism of action of solriamfetol is unclear, but its efficacy may be related to its activity as a selective dopamine and norepinephrine reuptake inhibitor (DNRI). Unlike traditional stimulants, it does not promote monoamine release (Baladi 2018).
Distribution: Vd: ~199 L
Protein binding: Plasma: 13.3% to 19.4%
Metabolism: Minimal
Bioavailability: ~95%
Half-life elimination: ~7.1 hours
Time to peak: 2 hours (fasting); delayed an additional 1 hour with high-fat meal
Excretion: Urine (95% as unchanged drug)
Altered kidney function: Half-life prolonged 1.2-fold (eGFR 60 to 89 mL/minute/1.73 m2), 1.9-fold (eGFR 30 to 59 mL/minute/1.73 m2), and 3.9-fold (eGFR <30 mL/minute/1.73 m2) in patients with renal impairment. AUC and half-life increased in patients with ESRD. An average of 21% of solriamfetol is removed by hemodialysis.
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