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 2months prior to Screening, and remain stable until the double-blind, randomizedwithdrawal visit

• Females of childbearing potential must use highly effective contraception for 2months prior to Baseline, throughout the study, and for 30 days after the last doseof study drug

• Males with female partners of childbearing potential must use condoms throughout thestudy and for 30 days after the last dose of study drug

• Willing and able to provide informed consent and comply with the requirements of thestudy

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-hypopneaindex (AHI) ≥ 15 by American Academy of Sleep Medicine (AASM) 1A criteria

• Clinically significant parasomnias

• History or presence of seizures, head trauma, succinic semialdehyde dehydrogenasedeficiency, uncontrolled hypothyroidism, and/or significant hepatic impairment

• History or presence of bipolar and related disorders, schizophrenia, schizophreniaspectrum 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 centralnervous 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