Sedation
ADVERSE EVENTS, EVENTS, RESPIRATORY DEPRESSION, ADVERSE EVENT
Sedation was reported as an adverse event in 7.8% of participants. The majority (99.4%, 1073/1079) of sedation events occurred on a dosing day and resolved the same day. Five (0.4%) participants had 1 or more sedation events that did not resolve on the day of dosing. Sedation led to esketamine dose reduction for 1 of these participants.There were no serious adverse events of sedation or adverse events of sedation that led to withdrawal of study drug. No participant reported respiratory depression. An adverse event of oxygen saturation decreased was reported for four participants; all such events were transient and self-limited, none requiring any intervention. The four participants had MOAA/S scores of 5 (i.e., defined as participant readily responding to name spoken in normal tone [awake]).The MOAA/S scores of the study participants are summarized in the Supplement. Clinically-relevant sedation, defined by MOAA/S score ≤ 3 (i.e., moderate or greater sedation), occurred at least once among 6.1% (28/458) of participants in the induction phase and in 6.9% (77/1110) of participants in the optimization/maintenance phase.