Safety and tolerability
dizziness, TEAEs, somnolence
ADVERSE EVENT, EVENTS
Safety variables included physical examination, laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (blood pressure, pulse rate, respiratory rate, and body temperature), 12‐lead ECG, Columbia Suicide Severity Rating Scale (C‐SSRS), Stanford Sleepiness Scale (SSS), Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), and Drug Effects Questionnaire‐5 (DEQ‐5). Adverse events (AEs) were classified according to system organ class and preferred terms using the Medical Dictionary for Regulatory Activities, version 21.1. AEs reported after the initial dose of the study drug were considered treatment‐emergent AEs (TEAEs). TEAEs of special interest were sedation, recorded as a TEAE in case of an SSS score ≥6 or a MOAA/S score ≤2, as well as somnolence, dizziness, and events with suspected dependency.