Solriamfetoldosage

Administer once daily upon awakening. Avoid administration within 9 hours of planned bedtime because of the potential to interfere with sleep. Starting dose for patients with narcolepsy: 75 mg once daily. Starting dose for patients with OSA: 37.5 mg once daily. Dose may be increased at intervals of at least 3 days. Maximum dose is 150 mg once daily.

Renal impairment: Moderate impairment: Starting dose is 37.5 mg once daily. May increase to 75 mg once daily after at least 7 days.

Severe impairment: Starting dose and maximum dose is 37.5 mg once daily. End stage renal disease (ESRD): Not recommended.

2.1 Important

Considerations Prior to Initiating Treatment Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled.

2.2 General

Administration Instructions Administer SUNOSI orally upon awakening 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. SUNOSI 75 mg tablets are functionally scored tablets that can be split in half (37.5 mg) at the score line.

2.3 Dosage in

Narcolepsy Initiate SUNOSI at 75 mg once daily in adults with narcolepsy. The recommended dose range for SUNOSI is 75 mg to 150 mg once daily. Based on efficacy and tolerability, the dosage of SUNOSI may be doubled at intervals of at least 3 days. The maximum recommended dose is 150 mg once daily. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

2.4 Dosage in OSA

Initiate SUNOSI at 37.5 mg once daily in adults with OSA. The recommended dosage range for SUNOSI is 37.5 mg to 150 mg once daily. Based on efficacy and tolerability, the dosage of SUNOSI may be doubled at intervals of at least 3 days. The maximum recommended dosage is 150 mg once daily. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

2.5 Dosage Recommendations in

Patients with Renal Impairment Moderate renal impairment (eGFR 30-59 mL/min/1.73 m 2 ): Initiate dosing at 37.5 mg once daily. Based on efficacy and tolerability, dose may be increased to a maximum of 75 mg once daily after at least 7 days. Severe renal impairment (eGFR 15-29 mL/min/1.73 m 2 ): Administer 37.5 mg once daily. The maximum recommended daily dose is 37.5 mg. End Stage Renal Disease (eGFR <15 mL/min/1.73 m 2 ): SUNOSI is not recommended for use in patients with ESRD.