Posology : מינונים

4.2 Posology and method of administration

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 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).

Posology

Narcolepsy
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.

OSA
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.

Sunosi can be taken with or without food.

Taking Sunosi less than 9 hours before bedtime should be avoided as it may affect night timesleep.

Long-term use
The need for continued treatment and the appropriate dose should be periodically assessed during extended treatment in patients prescribed solriamfetol.

Special populations

Elderly (> 65 years)
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.

Renal impairment
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.
Paediatric population
The safety and efficacy of Sunosi in children and adolescents (<18 years old) have not yet been established. No data are available.

Method of administration

Sunosi is for oral use.
Administration of a 37.5 mg dose can be achieved by halving a 75 mg tablet using the score line.