Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

Inclusion Criteria: * Primary diagnosis of idiopathic hypersomnia * Total ESS score at Screening \> 11 if not on prior oxybate * Average nightly total sleep time of \> 7 hours * May use stimulants/alerting agents but dose and regimen must have been stable for 2 months prior to Screening, and remain stable until the double-blind, randomized withdrawal visit * Females of childbearing potential must use highly effective contraception for 2 months prior to Baseline, throughout the study, and for 30 days after the last dose of study drug * Males with female partners of childbearing potential must use condoms throughout the study and for 30 days after the last dose of study drug * Willing and able to provide informed consent and comply with the requirements of the study 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 hist…