Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

Exclusion Criteria

• •Pregnant, nursing or lactating females
• •Hypersomnia due to another medical, behavioral, sleep, or psychiatric condition
• •Untreated or incompletely treated sleep apnea in patients with an apnea-hypopnea index (AHI) ≥ 15 by American Academy of Sleep Medicine (AASM) 1A criteria
• •Clinically significant parasomnias
• •History or presence of seizures, head trauma, succinic semialdehyde dehydrogenase deficiency, uncontrolled hypothyroidism, and/or significant hepatic impairment
• •History or presence of bipolar and related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders
• •Ongoing or past (within 1 year) major depressive episode
• •At risk for suicide or history of suicide attempt
• •If not on oxybate at Screening, treatment or planned treatment with any central nervous system (CNS) sedating agents during study
• •Current or past substance use disorder (including alcohol or cannabinoids)
• •Excessive caffeine consumption (\> 600 mg/day)
• •Prior treatment with either FT218 or LUMRYZ