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SUNOSI is a brand name for Solriamfetol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SUNOSI® (solriamfetol) is indicated for: • The treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. • The treatment of excessive daytime sleepiness in adult patients with obstructive sleep apnea (OSA). SUNOSI is not indicated to treat the underlying airway obstruction in patients with…
Verbatim from this product's HC label. Tap a section to expand.
4 WARNINGS AND Precautions, Special Populations, Geriatrics >65 years). 2 CONTRAINDICATIONS SUNOSI is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see
2 CLINICAL PHARMACOLOGY, Pharmacodynamics, Cardiac Electrophysiology). , sympathomimetics) has not been evaluated. 2 CLINICAL PHARMACOLOGY, Pharmacodynamics, Cardiac Electrophysiology). 3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions).
• Administer once daily upon awakening, with or without food. • Avoid taking SUNOSI within 9 hours of planned bedtime because of the potential to interfere with sleep. • Long-term use: The need for continued treatment and the appropriate dose should be periodically assessed during extended treatment in patients prescribed SUNOSI.
• Not a therapy for the underlying airway obstruction in patients with OSA. Primary OSA therapy should be maintained in these patients. 2 Recommended Dose and Dosage Adjustment • Narcolepsy o The recommended starting dose is 75 mg once daily, upon awakening.
o Depending on clinical response and tolerability, the dose can be titrated to a higher level by doubling the dose after an interval of at least 3 days. The recommended maximum daily dose is 150 mg once daily. Doses above 150 mg once daily did not confer additional benefit to outweigh dose-related adverse events (see 7 WARNINGS AND PRECAUTIONS).
5 mg once daily, upon awakening. o Depending on clinical response and tolerability, the dose can be titrated to a higher level by doubling the dose at intervals of at least 3 days. The recommended maximum daily dose is 150 mg once daily.
Doses above 150 mg once daily did not confer additional benefit to outweigh dose-related adverse events (see 7 WARNINGS AND PRECAUTIONS). SUNOSI (solriamfetol) Page 6 of 38 • Patients with Renal Impairment o Mild renal impairment (creatinine clearance of 60-89 mL/min): No dose adjustment is required.
5 mg once daily. Based on tolerability, the dose may be increased to a maximum of 75 mg once daily after 7 days. 5 mg once daily can be used. 3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions). 3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions).
, Cardiovascular). 1 Dosing Considerations • Prior to initiating treatment, assess blood pressure and heart rate and ensure that blood pressure is adequately controlled. Monitor blood pressure and heart rate, during titration and periodically during treatment (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular; 8.
SUNOSI is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
2 DRUG INTERACTIONS, Drug Interactions Overview). • with myocardial infarction within the past year, unstable angina pectoris, uncontrolled hypertension, serious cardiac arrhythmias and other serious heart problems (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
• who have end-stage renal disease (see 4.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Pediatrics (<18 years of age) o Health Canada has not authorized an indication for pediatric use. 4 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics (>65 years)). 4 Administration Administer SUNOSI orally upon wakening, with or without food.
Avoid taking SUNOSI within 9 hours of planned bedtime because of the potential to interfere with sleep if taken too late in the day. 5 mg dose can be achieved by splitting the 75 mg tablet using the score line. 5 Missed Dose If the patient misses the scheduled morning dose, they may take it later in the day as long as it is not within 9 hours before bedtime.
Avoid taking SUNOSI less than 9 hours before bedtime as it may affect night time sleep. If the dose has been missed and it is less than 9 hours before bedtime, do not take this dose. Take the next scheduled dose the following morning.
5 OVERDOSAGE There have been no reports of overdose of solriamfetol in the clinical studies. In a clinical study involving healthy volunteers, there was one adverse event of mild tardive dyskinesia and one adverse event of moderate akathisia that occurred at a supratherapeutic dose of 900 mg; symptoms resolved after treatment discontinuation.
SUNOSI (solriamfetol) Page 7 of 38 A specific reversal agent for SUNOSI is not available. Hemodialysis removed approximately 21% of a 75 mg dose in end stage renal disease patients. In the case of inadvertent overdose, symptomatic and supportive medical care with careful monitoring, including cardiovascular monitoring, should be provided, as appropriate.
For management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844-POISON-X (1-844-764-7669). 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 - Dosage Forms, Strengths, Composition and Packaging Sample blister pack of 7 tablets for 75 mg.
Packaged in blister strips containing 28 or 56 tablets. Packaged in bottles with child-resistant cap containing 30 or 100 tablets. Not all pack sizes may be marketed. 7 WARNINGS AND PRECAUTIONS Cardiovascular Blood Pressure and Heart Rate In 12-week controlled clinical trials in patients with narcolepsy and OSA, treatment with SUNOSI increased mean systolic blood pressure, mean diastolic blood pressure and mean heart rate relative to placebo in a dose-dependent manner across […]