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    Sunosi™

    Drug - Sunosi™ (Solriamfetol) [Jazz Pharmaceuticals Inc.]

    January 2020

    Therapeutic Area - Stimulants and Related Agents

    Approval criteria

    • Patient is ≥ 18 years old; AND
    • Patient has an International Classification of Sleep Disorders (ICSD-3) diagnosis of obstructive sleep apnea (OSA) OR an ICSD-3 or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of narcolepsy; AND
    • Patient has a baseline Epworth Sleepiness Scale (ESS) score of ≥ 10; AND
    • Patient does not have end stage renal disease (estimated glomerular filtration rate [eGFR] < 15 mL/min/1.73 m2); AND
    • Patient must have blood pressure assessed and hypertension controlled (≤ 140/90 mmHg) prior to initiating treatment; AND
    • Patient is not receiving a monoamine oxidase inhibitor (MAOI) and has not received an MAO inhibitor within 14 days; AND
    • Patient is not receiving concomitant noradrenergic medications; AND
    • Patient is not receiving concomitant pitolisant, sodium oxybate or armodafinil; AND
    • Patient cannot have a history of moderate to severe substance or alcohol use disorder according to DSM-5 criteria; AND
    • Patient must not have a current or prior DSM-5 diagnosis of a concomitant psychotic disorder; AND
    • Patient does not have nicotine dependence that has an effect on sleep (e.g., a person who routinely awakens at night to smoke); AND
    • Patient must have tried and failed an adequate trial of modafinil; AND
    • If used for OSA, patient must meet the following requirements:
      • Prescriber attestation that patient is compliant with and will continue using positive airway pressure (PAP); AND
      • Prescriber has excluded any other identifiable causes for patient’s sleepiness (e.g., non-compliance with PAP, improperly fitted PAP mask, insufficient sleep, poor sleep hygiene, depression, and/or other sleep disorders); AND
      • Prescriber attestation that the patient must use it for at least 4 hours daily if prescribed a BiPAP machine

    Renewal criteria

    • Patient must continue to meet the above criteria; AND
    • Patient has not developed increased blood pressure or heart rate that was not controlled by a dose reduction of solriamfetol or medical intervention.

    Quantity limits

    • 150 mg/day; 4,500 mg/30 days

    Background

    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.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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