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SOLRIAMFETOL TAB

Clinical Criteria Summary

Exclusion Criteria

  • OSA not receiving primary OSA therapy (e.g., CPAP, or other OSA therapy for patients for whom CPAP was intolerable or ineffective (dental appliance, hypoglossal nerve stimulator, OSA surgery, or other)
  • Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of a MAOI within the preceding 14 days
  • Patient has uncontrolled hypertension, unstable non medically controlled angina or coronary artery disease, non medically controlled heart arrhythmias, or other clinically relevant unstable or untreated heart problems
  • End Stage Renal Disease (eGFR less than 15 ml/min/1.73m2)

Inclusion Criteria & Indications

  • Treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA)
  • Documented lack of efficacy with, is intolerant of, or has contraindications to modafinil OR armodafinil

Diagnostic Requirements

  • If narcolepsy is the indication, the diagnosis of narcolepsy has been confirmed by Multiple Sleep Latency Test (MSLT) or hypocretin-1 deficiency
  • Documented excessive daytime sleepiness (Epworth Sleepiness Scale score > 10)

Monitoring & Prescribing Requirements

  • Prescribed and monitored by a VA/VA Community Care sleep specialist/pulmonologist/neurologist or locally designated expert in sleep disorders.

Source Documents