General Information

Igalmi (dexmedetomidine) sublingual film is an alpha2-adrenergic receptor agonist.

Igalmi is specifically indicted for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Dosing/Administration

Igalmi is supplied as a sublingual film for oral administration (under the tongue or against the cheek). Do not chew or swallow Igalmi. Do not eat or drink for at least 15 minutes after sublingual administration, or at least one hour after buccal administration.

Igalmi should be administered under the supervision of a healthcare provider. 

Dosing is based on level of agitation. If agitation persists after the initial dose, up to two additional doses may be administered at least two hours apart.

Igalmi 120 mcg and 180 mcg dosage strengths may be cut in half to obtain the 60 mcg and 90 mcg doses, respectively.

Please see drug label for dosing in patients with hepatic impairment and in geriatrics. 

Mechanism of Action

Dexmedetomidine is an alpha-2 adrenergic receptor agonist. The mechanism of action of IGALMI in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder is thought to be due to activation of presynaptic alpha-2 adrenergic receptors.

Side Effects

Adverse effects associated with the use of Igalmi may include, but are not limited to, the following:

• somnolence
• paresthesia or oral hypoesthesia
• dizziness
• dry mouth
• hypotension
• orthostatic hypotension

Clinical Trial Results

The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group Phase 3 trials evaluating Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II). 

The primary endpoint was the mean change from baseline in the Positive and Negative Syndrome Scale-Excited Component (PEC) total score assessed at 2 hours following dosing. In both trials, Igalmi met the primary endpoint at two hours after the first dose in patients treated with the 120 mcg and 180 mcg doses, demonstrating statistically significant improvements from baseline. Igalmi also met the key secondary endpoint, demonstrating a rapid onset of action, with statistically significant separation from placebo observed at 20 minutes for both the 180 mcg and 120 mcg doses in SERENITY II and 20 minutes and 30 minutes in SERENITY I, respectively.