Source: FDA, National Drug Code (US) Revision Year: 2020
SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)].
Limitations of Use:
SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities.
Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled [see Warnings and Precautions (5.1)].
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.
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)].
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)].
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)].
A specific reversal agent for SUNOSI is not available. Hemodialysis removed approximately 21% of a 75 mg dose in end stage renal disease patients. Overdoses should be managed with primarily supportive care, including cardiovascular monitoring.
Consult with a Certified Poison Control Center at 1-800-222-1222 for latest recommendations.
Store SUNOSI at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) (see USP controlled room temperature).
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
