Monitoring Patients on Sunosi (Solriamfetol)
Patients taking Sunosi require regular blood pressure and heart rate monitoring throughout treatment, with baseline assessment before initiation and periodic reassessment to detect dose-dependent cardiovascular elevations that increase risk of major adverse cardiovascular events. 1
Cardiovascular Monitoring (Primary Priority)
Blood pressure and heart rate increase in a dose-dependent manner with Sunosi, representing the most critical monitoring parameter. 1
Pre-Treatment Assessment
- Assess and control hypertension before initiating Sunosi - do not start until blood pressure is adequately managed 1
- Evaluate cardiovascular and cerebrovascular disease history
- Identify high-risk patients: those with known cardiovascular disease, pre-existing hypertension, advanced age, diabetes, hyperlipidemia, or high BMI 1
During Treatment
- Monitor blood pressure regularly throughout treatment 1
- Monitor heart rate at each visit
- Treat new-onset hypertension and exacerbations of pre-existing hypertension promptly 1
- Consider dose reduction or discontinuation if blood pressure or heart rate increases cannot be managed with appropriate medical intervention 1
Special Consideration
Patients with moderate or severe renal impairment face higher risk of blood pressure and heart rate elevations due to prolonged drug half-life 1
Psychiatric Symptom Monitoring
Observe patients for emergence or exacerbation of psychiatric symptoms, including anxiety, insomnia, irritability, agitation, psychosis, or bipolar disorder manifestations. 1
Key Points
- Common psychiatric adverse events include anxiety (5-7%), insomnia (5-6%) 1
- Exercise particular caution in patients with history of psychosis or bipolar disorders 1
- Sunosi has not been evaluated in patients with psychosis or bipolar disorders 1
- Patients with renal impairment have higher risk due to prolonged half-life 1
- Consider dose reduction or discontinuation if psychiatric symptoms develop 1
Common Adverse Events to Monitor
The most frequently reported adverse events (≥5% and greater than placebo) include: 1
- Headache (7-16% depending on indication)
- Nausea (4-7%)
- Decreased appetite (9% in narcolepsy)
- Anxiety (5-6%)
- Insomnia (5-6%)
- Dry mouth, constipation, palpitations, chest discomfort
Most adverse events are mild to moderate in severity, with approximately 47% occurring within the first 7 days of treatment. 2, 3
Renal Function Considerations
Monitor patients with renal impairment more closely, as they experience:
- Prolonged drug half-life
- Higher risk of cardiovascular effects
- Increased psychiatric symptom risk 1
Pregnancy and Breastfeeding Monitoring
- Solriamfetol may cause fetal harm based on animal data 2
- Advise breastfeeding patients to monitor infants for agitation, insomnia, and reduced weight 1
- Pregnancy registry available: 1-877-283-6220 or www.SunosiPregnancyRegistry.com 1
Abuse Potential Monitoring
Sunosi is a Schedule IV controlled substance with potential for abuse or dependency. 2, 1
- Assess history of drug or alcohol abuse before prescribing
- Monitor for signs of misuse or diversion
- Counsel patients on secure storage and proper disposal 1
Periodic Reassessment
Periodically reassess the need for continued treatment with Sunosi to ensure ongoing benefit justifies cardiovascular and other risks. 1