An observational study on the effects of as-needed use of various antipsychotic drugs for agitation due to psychotic disorders

Abstract

This multicenter, 6-month naturalistic observational study investigated the time from as-needed (PRN) administration of psychotropic medications to the onset of calming in patients with acute psychotic disorders. Newly admitted patients exhibiting moderate to marked agitation on the Agitation-Calmness Evaluation Scale (ACES) and requiring PRN treatment were included, and 170 first agitation episodes were analyzed. The primary outcome was time to onset of effect, defined as achieving ACES = 3. Medication refusal at baseline was far more frequent in patients with injectable formulations than those with oral or sublingual agents (65.5% vs. 4.3%). Kaplan–Meier estimates showed mean onset times (minutes) for oral/sublingual drugs as follows: asenapine sublingual, 30.0; olanzapine orally disintegrating tablet, 31.9; quetiapine, 46.6; and risperidone oral solution, 34.5. Using Cox proportional hazards models with asenapine as reference, quetiapine demonstrated a significantly lower hazard of achieving calming (hazard ratio 0.39), while risperidone showed a nonsignificant trend. For injectable antipsychotics, mean onset times were: olanzapine intramuscular, 36.3; haloperidol intramuscular, 47.5; and haloperidol intravenous, 45.0, with no significant differences among them. No serious adverse events were observed. The findings suggest that asenapine sublingual may offer faster calming in patients without refusal, and that future studies with shorter assessment intervals are warranted.