DARIDOREXANT TAB,ORAL
Clinical Criteria Summary
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Exclusion Criteria
- Narcolepsy
- Co-administration with strong CYP3A inhibitors
- Co-administration with moderate or strong CYP3A4 inducers
- Active substance use disorder
- Considered a high suicide risk
- Untreated significant sleep-related breathing disorder-obstructive or central sleep apnea syndrome
- Severe hepatic impairment (e.g., Child-Pugh C)
- Receiving other drugs to treat insomnia
- History of complex sleep behaviors
Inclusion Criteria
- Prescribed and monitored by a VA / VA Community Care sleep specialist or locally designated expert in sleep disorders
- Documented diagnosis of insomnia characterized by difficulties with sleep onset and/or sleep maintenance
- When available, cognitive behavioral therapy for Insomnia (CBT-I) has been tried, via face to face, tele-mental health or non-VA care
- An adequate short-term trial of 2 formulary sedative hypnotics for the treatment of sleep onset and maintenance have been tried and failed to resolve symptoms or were not tolerated
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Indication
- • Treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance
Dosing & Administration
- • Available as 25 mg and 50 mg tablets
- • Once daily administration
- • Clinically meaningful efficacy is supported only for the 50-mg dose based on AASM consensus criteria
Contraindications
- • Narcolepsy
Warnings & Precautions
- • CNS-depressant effects and daytime impairment
- • Worsening of depression/suicidal ideation
- • Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms
- • Complex sleep behaviors
- • Patients with compromised respiratory function
- • Need to evaluate for co-morbid diagnoses
Drug Interactions
- • Avoid co-administration with strong CYP3A inhibitors
- • Avoid co-administration with moderate or strong CYP3A4 inducers
Hepatic Impairment
- • Not recommended in severe hepatic impairment (Child-Pugh C)
Formulary & Regulatory Status
- • Non-Formulary (NF) with Clinical Formulary Utilization (CFU)
- • Schedule IV controlled substance