Sublingual dexmedetomidine for the treatment of acute agitation in adults with schizophrenia or schizoaffective disorder

The Journal of Clinical PsychiatryScott Cunningham MD PhD, et al. | October 04, 2022



Sublingual dexmedetomidine, a selective α2 adrenergic receptor agonist, was approved by the FDA for treatment of agitation in patients with schizophrenia and bipolar disorder. Sublingual dexmedetomidine was shown in the current study to have a rapid onset (20-30 min) and efficacy in reducing agitation in patients with schizophrenia.

This multi-site, phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy of sublingual dexmedetomidine (120 or 180 µg) versus placebo in patients with schizophrenia or schizoaffective disorder and acute agitation using the Positive and Negative Syndrome Scale-Excited Component (PEC) total score 2 h after administration.

The baseline PEC score among the 380 participants (mean age, 45.6 years) was 17.6, which indicated mild-to-moderate agitation. Two hours after receiving 120 µg or 180 µg of dexmedetomidine or placebo, the least squares mean changes were -10.3, -8.5, and -4.8, respectively.

The side effects of dexmedetomidine included somnolence, dry mouth, hypotension, dizziness, and oral hypoesthesia.