Participants
ideation, angina, seizures, sleep disorder, epilepsy, comorbid sleep disorders, obstructive hypopneas, cardiac rhythm abnormality, behavioral or psychiatric disorder, depression, apnea-hypopnea
CARDIAC ISCHEMIA, MYOCARDIAL INFARCTION, EPILEPSY, HEART FAILURE, CORONARY ARTERY DISEASE
Individuals meeting the following criteria were eligible for inclusion: aged 18–75 years inclusive; IH diagnosed according to ICSD-3 criteria, verified by nPSG and the MSLT within the prior 10 years; 7-day mean nightly sleep duration of ≥ 420 min (as measured by 7 days of actigraphy and sleep diary); mean sleep latency (of four sessions) on the maintenance of wakefulness test (MWT) of ≤ 20 min at baseline with no single MWT session having a sleep latency of > 30 min; and an Epworth Sleepiness Scale (ESS) score of ≥ 11 at screening and on study day −2.Key exclusion criteria included a usual bedtime later than midnight or an occupation requiring night-time or variable shift work; a history of a sleep disorder other than IH; or a health condition that could affect the safety of the participant, including coronary artery disease, prior myocardial infarction, angina, cardiac rhythm abnormality, heart failure, cardiac ischemia, epilepsy, or seizures, or any unstable behavioral or psychiatric disorder, including major depression or active suicidal ideation. Tobacco and nicotine-containing products, caffeine, and alcohol were prohibited during the study confinement periods. Concomitant medications, including psychostimulants, antipsychotic drugs, mood stabilizers, muscle relaxants, moderate or potent CYP3A inhibitors and inducers, and any sedating agents, were prohibited from the longer of 7 days or five half-lives before the administration of study drug. Sodium oxybate was required to be discontinued at least 4 weeks before screening.Following screening, participants underwent nPSG to confirm the absence of other comorbid sleep disorders and were required to have an apnea-hypopnea index of ≤ 10/h (defined according to the American Academy of Sleep Medicine recommended scoring for obstructive hypopneas [