What are the dosing, contraindications, precautions, and monitoring recommendations for Sunosi (solriamfetol) in adults with obstructive sleep apnea or narcolepsy?

Sunosi (Solriamfetol) Clinical Guide

Indications

Sunosi is strongly recommended for treating excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea, based on high-quality evidence demonstrating clinically significant improvements in wakefulness and sleepiness. 1

• Approved for excessive daytime sleepiness associated with narcolepsy or OSA in adults 2
• Does NOT treat cataplexy - only addresses excessive daytime sleepiness 3
• Not a substitute for treating underlying airway obstruction in OSA - patients must be on adequate CPAP or other OSA therapy for at least one month before initiating Sunosi 2

Dosing

Narcolepsy

• Starting dose: 75 mg once daily upon awakening 2
• May increase to 150 mg once daily based on efficacy and tolerability 2
• Titrate at intervals of at least 3 days by doubling the dose 2
• Maximum dose: 150 mg once daily (higher doses do not provide sufficient additional benefit to outweigh adverse effects) 2

Obstructive Sleep Apnea

• Starting dose: 37.5 mg once daily upon awakening 2
• May increase to 75 mg or 150 mg once daily based on response 2
• Titrate at intervals of at least 3 days by doubling the dose 2
• Maximum dose: 150 mg once daily 2

Administration

• Take upon awakening, with or without food 2
• Avoid taking within 9 hours of planned bedtime to prevent sleep interference 2
• The 75 mg tablet is functionally scored and can be split in half for 37.5 mg dosing 2

Renal Impairment Adjustments

• Moderate impairment (eGFR 30-59 mL/min/1.73 m²): Start at 37.5 mg once daily; maximum 75 mg once daily after at least 7 days 2
• Severe impairment (eGFR 15-29 mL/min/1.73 m²): 37.5 mg once daily maximum 2
• End-stage renal disease (eGFR <15 mL/min/1.73 m²): Not recommended 2

Contraindications

• Absolute contraindication: Concurrent use with MAO inhibitors or within 14 days of MAO inhibitor discontinuation due to risk of hypertensive crisis 2

Critical Precautions and Monitoring

Cardiovascular Monitoring (Most Important)

Sunosi causes dose-dependent increases in blood pressure and heart rate, which increase the risk of major adverse cardiovascular events including stroke, heart attack, and cardiovascular death. 2

• Assess and control blood pressure BEFORE initiating treatment 2
• Monitor blood pressure regularly during treatment 2
• Treat new-onset hypertension and exacerbations of pre-existing hypertension 2
• Exercise extreme caution in patients with:
  • Known cardiovascular or cerebrovascular disease 2
  • Pre-existing hypertension 2
  • Advanced age 2
  • Multiple MACE risk factors (diabetes, hyperlipidemia, high BMI) 2

Controlled Substance Status

• Schedule IV federally controlled substance with potential for abuse or dependency 1

Pregnancy and Lactation

• May cause fetal harm based on animal data; human data insufficient 1
• Risk-benefit balance is different for pregnant and breastfeeding women 1
• All narcolepsy medications lack sufficient human lactation data 4
• Consider non-pharmacological management (scheduled naps, sleep hygiene) as first-line in breastfeeding mothers 4

Common Adverse Events

• Headache, decreased appetite, insomnia, nausea, and chest discomfort 1
• Most adverse events are mild to moderate in severity 1
• Typically occur within 2 weeks of treatment initiation and resolve within 2 weeks 5
• Nasopharyngitis, dry mouth, anxiety, and upper respiratory tract infection also reported 6

Clinical Efficacy

• Demonstrated clinically significant improvements in excessive daytime sleepiness and disease severity in 3 high-quality RCTs 1
• Mean increase in sleep latency of 9.52 minutes on Maintenance of Wakefulness Test 7
• Mean reduction in Epworth Sleepiness Scale score of -3.74 to -4.44 points 7, 8
• 150 mg dose is the most appropriate and stable dose for excessive sleepiness 7
• Benefits sustained through 52 weeks of treatment 5, 6
• Clinically meaningful improvements in functional status, work productivity, and quality of life 6

Drug Interactions

• Use caution with other drugs that increase blood pressure and heart rate 2
• Avoid combining with MAO inhibitors (absolute contraindication) 2

Important Clinical Caveats

• Solriamfetol does NOT treat cataplexy - if cataplexy control is needed, consider sodium oxybate or pitolisant instead 3
• In OSA, continue primary airway obstruction treatment (CPAP) throughout Sunosi therapy 2
• Significantly increases risk of adverse events compared to placebo (RR 1.42-1.47) 7, 8
• No serious adverse event risk difference compared to placebo 7