Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Atnahs Pharma Netherlands B. V., Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Denmark
Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy).
Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).
Treatment should be initiated by a healthcare professional experienced in the treatment of narcolepsy or OSA.
Sunosi is not a therapy for the underlying airway obstruction in patients with OSA. Primary OSA therapy should be maintained in these patients.
Blood pressure and heart rate should be assessed before initiating treatment with solriamfetol and should be monitored periodically during treatment, especially after increasing the dose. Pre-existing hypertension should be controlled before initiating treatment with solriamfetol and caution should be exercised in treating patients at higher risk of major adverse cardiac events (MACE), particularly patients with pre-existing hypertension, patients with known cardiovascular or cerebrovascular disease and elderly patients.
The need for continued treatment with solriamfetol should be periodically assessed. If a patient experiences increases in blood pressure or heart rate that cannot be managed with dose reduction of solriamfetol or other appropriate medical intervention, discontinuation of solriamfetol should be considered. Caution should be exercised when using other medicinal products that increase blood pressure and heart rate (see section 4.5).
The recommended starting dose is 75 mg once daily, upon awakening. If clinically indicated in patients with more severe levels of sleepiness, a starting dose of 150 mg may be considered. Depending on clinical response, the dose can be titrated to a higher level by doubling the dose at intervals of at least 3 days, with a recommended maximum daily dose of 150 mg once daily.
The recommended starting dose is 37.5 mg once daily, upon awakening. Depending on clinical response, the dose can be titrated to a higher level by doubling the dose at intervals of at least 3 days, with a recommended maximum daily dose of 150 mg once daily.
Taking Sunosi less than 9 hours before bedtime should be avoided as it may affect night time sleep.
The need for continued treatment and the appropriate dose should be periodically assessed during extended treatment in patients prescribed solriamfetol.
Limited data are available in elderly patients. Consideration should be given to the use of lower doses and close monitoring in this population (see section 4.4). Solriamfetol is predominantly eliminated by the kidney and since elderly patients are more likely to have decreased renal function, dosing may need to be adjusted based on creatinine clearance in these patients.
Mild renal impairment (creatinine clearance of 60-89 mL/min): No dose adjustment is required.
Moderate renal impairment (creatinine clearance of 30-59 mL/min): The recommended starting dose is 37.5 mg once daily. Dose may be increased to a maximum of 75 mg once daily after 5 days.
Severe renal impairment (creatinine clearance of 15-29 mL/min): The recommended dose is 37.5 mg once daily.
End stage renal disease (creatinine clearance <15 mL/min): Solriamfetol is not recommended for use in patients with end stage renal disease.
The safety and efficacy of Sunosi in children and adolescents (<18 years old) have not yet been established. No data are available.
Sunosi is for oral use.
Sunosi can be taken with or without food.
Administration of a 37.5 mg dose can be achieved by halving a 75 mg tablet using the score line.
There have been no reports of overdose of solriamfetol in the clinical studies.
In healthy volunteers, there was one adverse reaction of mild tardive dyskinesia and one adverse reaction of moderate akathisia that occurred at a supratherapeutic dose of 900 mg; symptoms resolved after treatment discontinuation.
There is no specific antidote. In the case of inadvertent overdose, symptomatic and supportive medical care should be provided and patients should be carefully monitored, as appropriate.
5 years.
Bottles after first opening: 120 days.
Blisters: This medicinal product does not require any special storage conditions.
Bottles: Once opened, use within 4 months. Keep the container tightly closed in order to protect from moisture.
7 × 1 film coated tablets in PVC/PCTFE/Aluminium perforated unit dose blisters.
PVC/PCTFE/Aluminium blister.
Packs containing 7, 28 or 56 film-coated tablets.
High density polyethylene (HDPE) bottle with polypropylene (PP) child-resistant cap with integrated silica gel desiccant. Each bottle contains 30 or 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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