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    Dayvigo™

    Drug - Dayvigo™ (lamborexant) [Eisai, Inc.]

    September 2020

    Therapeutic area - Sedative Hypnotics

    Initial approval criteria

    • Patient is ≥ 18 years old AND
    • Dayvigo is prescribed by a provider specializing in sleep disorders AND
    • Patient has a confirmed diagnosis of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance AND
    • Patient has tried nonpharmacological therapy and/or cognitive behavioral therapy (CBT) AND
    • Patient must have a 1-month trial of each of the following medication, unless contraindicated:
      • Eszopiclone AND
      • Zolpidem AND
      • Zaleplon AND
    • Patient must NOT have narcolepsy AND
    • Patient will NOT be on another sedative hypnotic AND
    • Patient does NOT have severe hepatic impairment (Child-Pugh class C) AND
    • Patient is NOT taking any of the following drugs which should be avoided:
      • Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) or moderate CYP3A4 inhibitors (e.g., fluconazole, verapamil) OR
      • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s wort) or moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil) AND
    • Patient is prescribed no more than 5 mg lemborexant with weak CYP3A inhibitors (e.g., chlorzoxazone, ranitidine) and in patients with moderate hepatic impairment (Child-Pugh class B) AND
    • Prescriber attestation that underlying physical conditions (e.g., pain, discomfort, environmental issues) and/or comorbid conditions have been evaluated and treated, yet symptoms of insomnia persist AND
    • Prescriber attests that concurrent medications that may contribute to insomnia (e.g., stimulants, selective serotonin reuptake inhibitors [SSRIs], decongestants, steroids) have been reviewed
    • Initial approval is for 6 months

    Renewal criteria

    • Patient must continue to meet the initial criteria above AND
    • Prescriber attestation of efficacy AND
    • Patient has NOT experienced treatment-limiting adverse effects (e.g., worsening of depression, suicidal ideation, falls due to somnolence, complex sleep behaviors such as sleep-walking, sleep-driving, and engaging in other activities while not fully awake) AND
    • Renewal approval is for 6 months

    Quantity limits

    • 34 tablets/34 days

    Questions?

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

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