Dexmedetomidine for Agitation in the Hospital

A dissolving film calmed agitated inpatients as fast as oral lorazepam

STUDY: Faden J et al, Journal of Clinical Psychopharmacology 2026

STUDY TYPE: Randomized, open-label, active-controlled trial

FUNDING: BioXcel (dexmedetomidine manufacturer)

Background

Dexmedetomidine sublingual is FDA-approved as Igalmi for acute agitation associated with psychiatric illness (schizophrenia and bipolar disorder). It is an α2-adrenergic agonist that induces calm without respiratory depression, though bradycardia and hypotension are risks.

It succeeded against placebo in two large trials, and this small study is the first to test it against a benzodiazepine for psychiatric agitation.

The Study

• 24 psychiatric inpatients, ages 18 to 55, with schizophrenia, schizoaffective disorder, or bipolar disorder.
• Randomized to sublingual dexmedetomidine (120 or 180 mcg) or oral lorazepam 2 mg.
• Followed 2 hours; primary outcome was change on a 5-item agitation scale.

Results

Both treatments worked fast and similarly. Agitation scores dropped within 15 minutes and kept falling. By 2 hours, scores fell a median of 13.0 points with dexmedetomidine and 14.0 with lorazepam, similar relative reductions near 72% and 71%. A meaningful response occurred in 75% on dexmedetomidine versus 83% on lorazepam, not statistically tested given the small sample. Satisfaction ran higher with dexmedetomidine (67% versus 42%).

Side Effects and Risks

No spontaneously reported adverse events occurred in either group or no one dropped out for tolerability. Oral numbness, seen in prior trials, wasn’t specifically assessed here.

Dexmedetomidine is contraindicated in heart block, and causes dose-dependent bradycardia and hypotension requiring hemodynamic monitoring; it lacks respiratory depression, a relative advantage over benzodiazepines.

Limitations

The trial stopped early at 24 of a planned 32 and wasn’t powered for between-group comparisons; results are descriptive. It was open-label, risking expectation bias, and severely hostile patients may be underrepresented.

Practice Implications

1. Sublingual dexmedetomidine is a reasonable option for agitated patients able to place a film under the tongue.
2. It is not well-suited for combative patients, as it requires cooperation to take.
3. Have patients avoid food and drink for 15 minutes after dosing; the 360-mcg daily maximum may not suffice for severe agitation.
4. Given the small, industry-funded, open-label design, treat this as promising, not proof.

—Chris Aiken, MD
Director, Psych Partners
Editor in Chief, Carlat Psychiatry Report

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