New nightly pill aims to tame daytime sleepiness in rare sleep disorder

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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