Last reviewed 2026-04-23 · How we verify

Dexmedetomidine Sublingual

Alpha-2 adrenergic receptor agonist

Alpha-2 adrenergic receptor agonist Used for Sedation.

At a glance

Mechanism of action

Dexmedetomidine acts as an agonist at the alpha-2 adrenergic receptor, which results in sedative and anxiolytic effects.

Approved indications

• Sedation

Common side effects

• Dry mouth
• Hypotension
• Bradycardia

Key clinical trials

• Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia (PHASE2)
• BXCL501 After Stress to Increase Recovery Success (PHASE2)
• Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department (PHASE4)
• Sublingual Dexmedetomidine for Treating Opioid Withdrawal (PHASE1, PHASE2)
• Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder (PHASE4)
• Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) (PHASE3)
• Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II) (PHASE3)
• Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Dexmedetomidine Sublingual CI brief — competitive landscape report
• Dexmedetomidine Sublingual updates RSS · CI watch RSS
• NYU Langone Health portfolio CI