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LEMBOREXANT TAB

Clinical Criteria Summary

Exclusion Criteria

  • Narcolepsy
  • Co-administration with strong or moderate CYP3A4 inhibitors and inducers
  • Active substance use disorder
  • Actively suicidal or evaluated as being a high suicide risk
  • Untreated significant sleep-related breathing disorder-obstructive or central sleep apnea syndrome
  • Severe hepatic impairment (e.g., Child-Pugh C)
  • 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
  • An adequate trial of daridorexant has been tried and failed or was not tolerated

Source Documents