IGALMI

Dexmedetomidine exposure (C max and AUC) increased in a dose proportional manner in the dose range of 20 mcg (0.17 times the lowest recommended initial dose of 120 mcg) to 180 mcg after single sublingual administration of IGALMI. The mean time for film to dissolve in the mouth was about 6 to 8 minutes and 18 minutes following sublingual and buccal administration, respectively. Dexmedetomidine was quantifiable in plasma generally after 5 to 20 minutes post dosing.

AbsorptionThe absolute bioavail...

The effectiveness of IGALMI for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults was established in two randomized, double-blind, placebo-controlled, fixed-dose studies (Studies 1 and 2):

Study 1(NCT04268303) included 380 patients who met DSM-5 criteria for schizophrenia, schizoaffective or schizophreniform disorder. The population was 18 to 71 years of age (mean age was 46 years old); 37% female and 63% male; 78% Black, 20% White, 1% multiracial, and 1% Asian.

Study 2(NCT04276883) included 378 patients who met DSM-5 criteria for bipolar I ...

The following adverse reactions are discussed in detail in other sections of the labeling: Hypotension, Orthostatic Hypotension, and Bradycardia [see Warnings and Precautions (5.1) ] QT Interval Prolongation [see Warnings and Precautions (5.2) ] Somnolence [see Warnings and Precautions (5.3) ] Risk of Withdrawal Reactions [see Warnings and Precautions (5.4) ] Tolerance and Tachyphylaxis [see Warnings and Precautions (5.5) ] The most common adverse reactions (incidence ≥5% and at least twice the ...

None. None. ( 4 )

Hypotension, Orthostatic Hypotension, and Bradycardia: Avoid use of IGALMI in patients with hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope. Ensure that patients are alert and not experiencing orthostatic or symptomatic hypotension prior to resuming ambulation. ( 5.1 ) QT Interval Prolongation: IGALMI prolongs the QT interval; avoid use in patients with risk factors for prolonged QT interval. ( 5.2 ) Somnolence: Patients should no...

7 DRUG INTERACTIONS Drugs that Prolong the QT interval: Avoid use. ( 7.1 ) Anesthetics, Sedatives, Hypnotics, Opioids: Concomitant use may cause enhanced CNS depressant effects. Reduction in dosage of IGALMI or the concomitant medication may be required. ( 7.2 ) 7.1 Drugs that Prolong the QT Interval Concomitant use of drugs that prolong the QT interval may add to the QT-prolonging effects of IGAL...