Dexmedetomidine sublingual

IGALMI

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Pronunciation: dex-med-e-TOE-mi-deen

Dexmedetomidine sublingual ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Dexmedetomidine sublingual ballicule

Dexmedetomidine sublingual IGALMI mascot mnemonic cartoon — Visual mnemonic: Dexmedetomidine sublingual mascot
**“It calm me”**
orange plus signs → alpha-2 agonist

What it isSublingual alpha-2A agonist dexmedetomidine; acute agitation in schizophrenia or bipolar disorder.

Why this oneThe film provides noninvasive calming without dopamine blockade, a distinctive alternative to injected antipsychotics.

What limits itHypotension, orthostasis, and bradycardia are dose-limiting, so it is used under observation, not sent home.

Dexmedetomidine sublingual molecular structure (skeletal formula) — Molecular structure: Dexmedetomidine sublingual

FDA label

Read the full label on DailyMed ↗

FDA dosing	Population	Start	Target	Max
Acute treatment of agitation associated with schizophrenia or bipolar I/II disorder	Adults — mild/moderate agitation	120 mcg SL/buccal	120 mcg + up to two 60 mcg doses ≥2 h apart	240 mcg/day
Acute treatment of agitation associated with schizophrenia or bipolar I/II disorder	Adults — severe agitation	180 mcg SL/buccal	180 mcg + up to two 90 mcg doses ≥2 h apart	360 mcg/day
Acute treatment of agitation (schizophrenia or bipolar I/II)	Geriatric (≥65 yr), any severity	120 mcg SL/buccal	120 mcg + up to two 60 mcg doses ≥2 h apart	240 mcg/day

Renal No adjustment needed

Hepatic Reduce dose: mild/moderate (Child-Pugh A/B) start 90 mcg (mild/mod agitation) or 120 mcg (severe); severe (Child-Pugh C) start 60 mcg (mild/mod) or 90 mcg (severe)

If agitation persists, up to two additional doses may be given at least 2 hours apart; effectiveness not established beyond 24 hours from first dose

Instructions

Administer under supervision of a healthcare provider; monitor vital signs and alertness to prevent falls/syncope
Place film sublingually or buccally; do not chew or swallow
Do not eat or drink for at least 15 minutes after sublingual, or 1 hour after buccal, administration
Assess orthostatic vitals before any subsequent dose; additional half-doses not recommended if SBP <90, DBP <60, HR <60, or orthostatic drop

Available strengths

film 0.12, 0.18 mg
SL film 120, 180 mcg
inj 4, 100 mcg/mL

Cautions

Hypotension, orthostatic hypotension, and bradycardia (dose-dependent); avoid in hypotension, advanced heart block, severe ventricular dysfunction, or syncope history
QT interval prolongation — avoid with risk factors
Somnolence — no mentally alert activities for at least 8 hours after dosing
Risk of withdrawal reactions
Tolerance and tachyphylaxis

Adverse reactions

Somnolence, oral paresthesia/hypoesthesia, dizziness, dry mouth, hypotension, orthostatic hypotension
Bradycardia, nausea

Pregnancy No data on Igalmi in pregnancy; dexmedetomidine crosses the placenta; animal fetal toxicity at maternally toxic doses

Lactation Dexmedetomidine present in human milk (IV data); monitor breastfed infant for irritability

Cost

Dexmedetomidine sublingual (IGALMI)

Strength		#/mo	generic $/unit	CostPlus
0.12 mg	film	per unit		not offered
0.18 mg	film	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Dexmedetomidine sublingual is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Other forms: Dexmedetomidine (PRECEDEX)

NO BOXED WARNINGS

Principal riskHypotension, orthostasis and bradycardia

Classes and tags

Clinical profile

Direct muscarinic antagonism0 / 4

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Memory aids: interaction avatars

Box: minimal PK interactions

Open Dexmedetomidine sublingual in the interactive console ↗