Solriamfetol for Treatment of Excessive Daytime Sleepiness
Solriamfetol is strongly recommended for the treatment of excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea. 1
Indications and Mechanism
- Solriamfetol (SUNOSI®) is FDA-approved for improving wakefulness in adults with excessive daytime sleepiness associated with narcolepsy (type 1 and type 2) or obstructive sleep apnea (OSA) 2
- It functions as a selective dopamine and norepinephrine reuptake inhibitor, which distinguishes it from amphetamines as it lacks monoamine-releasing effects at therapeutic doses 3
- Classified as a Schedule IV controlled substance due to its potential for abuse or dependency, though it may have reduced abuse potential compared to other stimulants 1, 3
Efficacy
- High-quality evidence from 3 randomized controlled trials demonstrates clinically significant improvements in:
- Effects are dose-dependent, with improvements observed as early as week 1 and sustained through 52 weeks of treatment 2
- For narcolepsy, the recommended dosage range is 75-150 mg once daily 2
- For OSA, the recommended dosage range is 37.5-150 mg once daily 2, 4
Safety Profile
- Common adverse events include:
- Most adverse events are mild to moderate in severity and typically occur within 2 weeks of treatment initiation, resolving within 2 weeks 2
- Based on animal data, solriamfetol may cause fetal harm, though human data are insufficient to determine risk 1
Clinical Considerations
- Solriamfetol may cause false positive results on urine amphetamine immunoassays (specifically the Beckman Emit® II Plus Amphetamines Assay), which is important to consider in patients undergoing drug testing 5
- The American Academy of Sleep Medicine Task Force determined that the benefits of solriamfetol outweigh the risks and adverse events, with the balance strongly favoring its use 1
- Emerging research suggests potential benefit for excessive daytime sleepiness in Parkinson's disease, though further studies are needed 6
Comparison to Other Treatments
- Solriamfetol represents an alternative to other wakefulness-promoting medications like modafinil, armodafinil, and sodium oxybate 1
- Unlike some other medications used for narcolepsy, solriamfetol has not been shown to improve cataplexy symptoms 1
- The risk-benefit profile is different for pregnant and breastfeeding women, requiring careful consideration in these populations 1
Monitoring and Follow-up
- Assess treatment response using validated measures of daytime sleepiness and functional impairment 4
- Monitor for potential side effects, particularly during the first two weeks of treatment 2
- For patients with OSA, ensure continued adherence to primary OSA treatment (e.g., CPAP) as solriamfetol treats the symptom of excessive sleepiness but not the underlying sleep disorder 4