Dexmedetomidine sublingual
IGALMI
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.
FDA label
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| 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
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
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Dexmedetomidine sublingual ballicule
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Memory aids: mascots and interaction avatars
orange plus signs → alpha-2 agonist
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