Igalmi Shortage: What Providers and Prescribers Need to Know in 2026
As a clinician managing acute agitation in psychiatric or emergency settings, you may have encountered access challenges with Igalmi (Dexmedetomidine sublingual film). This provider briefing covers the current availability landscape, prescribing implications, and practical strategies for ensuring your patients receive appropriate treatment in 2026.
Provider Briefing: Igalmi in 2026
Igalmi is a sublingual film formulation of Dexmedetomidine, an alpha-2 adrenergic receptor agonist, approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It offers a non-injectable alternative with a mechanism distinct from traditional antipsychotics and benzodiazepines.
Key clinical attributes that differentiate Igalmi:
- Non-invasive administration: Sublingual or buccal film, eliminating the need for IM injections
- Unique mechanism: Alpha-2 agonism producing cooperative sedation without significant respiratory depression
- Rapid onset: Clinical effects typically observed within 20-30 minutes
- Dose-dependent effects: 120 mcg for mild-moderate agitation, 180 mcg for severe agitation
- Not a controlled substance: No DEA scheduling requirements
Timeline of Igalmi Availability
Understanding the trajectory of Igalmi's market presence helps contextualize current availability:
- April 2022: FDA approval of Igalmi (NDA 215390) for acute agitation in schizophrenia and bipolar disorder
- 2022-2023: Initial commercial launch with distribution focused on large hospital systems and psychiatric facilities
- 2024-2025: Gradual expansion of distribution; BioXcel Therapeutics working to broaden formulary adoption
- 2026: No FDA-listed shortage, but availability remains limited at many facilities due to distribution model and formulary gaps
Prescribing Implications
When considering Igalmi for your patients, keep these clinical factors in mind:
Dosing and Administration
- Adults, mild-moderate agitation: 120 mcg sublingual/buccal; may give up to two additional 60 mcg doses at ≥2-hour intervals (max 240 mcg/day)
- Adults, severe agitation: 180 mcg sublingual/buccal; may give up to two additional 90 mcg doses at ≥2-hour intervals (max 360 mcg/day)
- Geriatric patients (≥65 years): 120 mcg regardless of severity; additional 60 mcg doses (max 240 mcg/day)
- Hepatic impairment: Dose reduction required — see full prescribing information for Child-Pugh class-specific guidance
Monitoring Requirements
Igalmi must be administered under provider supervision with vital sign monitoring. Key monitoring parameters:
- Blood pressure (risk of hypotension — mean SBP decrease of 13-15 mmHg at 2 hours)
- Heart rate (risk of bradycardia — 7% of patients experienced HR ≤50 bpm with 180 mcg)
- Orthostatic vital signs at 2, 4, and 8 hours post-dose
- Alertness level — patients should not drive or operate machinery for ≥8 hours
Contraindications and Cautions
While Igalmi has no absolute contraindications per labeling, clinical judgment warrants avoidance in:
- Pre-existing hypotension (SBP <110 mmHg) or orthostatic hypotension
- Advanced heart block or severe ventricular dysfunction
- History of syncope
- Concurrent use of QT-prolonging agents
- Concurrent benzodiazepines, opioids, or other CNS depressants (dose adjustment required)
Current Availability Picture
The current Igalmi availability landscape in 2026:
- FDA shortage status: Not listed as shortage
- Manufacturer: BioXcel Therapeutics remains the sole source
- Generic status: No generic sublingual Dexmedetomidine available
- Primary distribution: Hospital pharmacies, psychiatric inpatient facilities, crisis stabilization units
- Retail pharmacy availability: Minimal — not a typical retail pharmacy stock item
The practical challenge is not production shortage but rather distribution model limitations and formulary adoption gaps. Many facilities haven't added Igalmi to their formulary, creating access barriers even when supply exists.
Cost and Access Considerations
Pricing and coverage details relevant to your prescribing decisions:
- Facility acquisition cost: Varies by contract; approximate retail/cash price is $95-$105 per film
- Insurance coverage: Variable; prior authorization commonly required
- Medicare Part B: May cover as provider-administered medication
- No patient copay program currently: Contact BioXcel Therapeutics at 1-833-201-1088 for current patient support offerings
For providers looking to help patients navigate costs, see our guide: How to help patients save money on Igalmi.
Tools and Resources for Providers
Practical resources to improve Igalmi access for your patients:
- Medfinder for Providers: medfinder.com/providers — search for facilities with Igalmi in stock and connect with availability data
- BioXcel Therapeutics Medical Information: 1-833-201-1088 or medinfo@bioxceltherapeutics.com
- Igalmi prescribing information: igalmi.com
- Formulary advocacy: If your facility doesn't carry Igalmi, consider presenting evidence to your P&T committee for formulary inclusion
Clinical Alternatives When Igalmi Is Unavailable
When Igalmi isn't accessible, evidence-based alternatives for acute agitation include:
- Haloperidol (Haldol) 5-10 mg IM: Well-established, inexpensive; monitor for EPS and QT prolongation
- Olanzapine (Zyprexa) 10 mg IM: Lower EPS risk; do not combine with benzodiazepines
- Lorazepam (Ativan) 2 mg IM: Effective for non-specific agitation; monitor respiratory status
- Ziprasidone (Geodon) 10-20 mg IM: Can combine with benzodiazepines; significant QT risk
For a detailed comparison, see: Alternatives to Igalmi.
Looking Ahead
Several developments may affect Igalmi access in the coming months and years:
- Potential expansion of distribution channels as BioXcel Therapeutics scales operations
- Ongoing real-world evidence accumulation may support broader formulary adoption
- Potential future indications (dementia-related agitation studies have been explored)
- No imminent generic entry expected
Final Thoughts
Igalmi represents a meaningful addition to the acute agitation treatment armamentarium, offering a non-injectable option with a unique mechanism. While not in formal shortage, real-world access challenges persist in 2026. Providers can improve patient access by advocating for formulary inclusion, utilizing tools like Medfinder for Providers, and maintaining familiarity with alternative protocols when Igalmi is unavailable.
Additional provider resources:
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