Bipolar disorder is a mental health condition that affects an estimated 2.3 million Americans. It is characterized by extreme mood swings, including episodes of mania and depression. Acute agitation is common in patients with bipolar disorder, which requires urgent management to relieve distress and to prevent escalation to aggressive behavior.
A clinical trial was conducted to evaluate the effect of sublingual dexmedetomidine, a sedative, on symptoms of acute agitation in patients with bipolar disorder. The trial enrolled 380 adults with bipolar I or II disorder and mild to moderate agitation. Participants were randomized to 3 groups: sublingual dexmedetomidine 180 μg, sublingual dexmedetomidine 120 μg, or placebo. The primary efficacy endpoint was the mean change from baseline at 2 hours for the Positive and Negative Syndrome Scale-Excited Component (PEC) total score.
The trial found that sublingual dexmedetomidine at a dose of 180 μg or 120 μg reduced mild to moderate agitation in patients with bipolar disorder. Two hours after taking the medication, the mean changes from baseline in PEC total score were −10.4 for sublingual dexmedetomidine 180 μg, −9.0 for sublingual dexmedetomidine 120 μg, and −4.9 for placebo. Treatment effects began 20 minutes after taking the medication among patients in the sublingual dexmedetomidine groups.
Adverse events occurred in 35.7% of patients taking 180 μg of dexmedetomidine, 34.9% taking 120 μg, and 17.5% taking placebo. The most common adverse events in the dexmedetomidine groups were somnolence, dry mouth, hypotension, and dizziness.