Important Considerations Prior to Initiating Treatment

Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled [see Warnings and Precautions (5.1)].

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.

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 [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (5.1)].

Dosage Recommendations in Patients with Renal Impairment

Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2): 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 [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Severe renal impairment (eGFR 15-29 mL/min/1.73 m2): Administer 37.5 mg once daily. The maximum recommended daily dose is 37.5 mg [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

End Stage Renal Disease (eGFR <15 mL/min/1.73 m2): SUNOSI is not recommended for use in patients with ESRD [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].