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Intranasal Midazolam
Midazolam is a benzodiazepine that enhances the inhibitory effects of GABA at GABA-A receptors in the central nervous system, producing sedation and anxiolysis.
Midazolam is a benzodiazepine that enhances the inhibitory effects of GABA at GABA-A receptors in the central nervous system, producing sedation and anxiolysis. Used for Acute seizure management, Acute anxiety and agitation, Procedural sedation.
At a glance
| Generic name | Intranasal Midazolam |
|---|---|
| Also known as | IN Midazolam, Dormire injectable solution, Cristalia, São Paulo, Brazil, Versed, IN midazolam, Intranasal Versed |
| Sponsor | Hamad Medical Corporation |
| Drug class | Benzodiazepine |
| Target | GABA-A receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology; Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Midazolam binds to GABA-A receptors and potentiates the effect of the inhibitory neurotransmitter GABA, leading to increased chloride ion influx and neuronal hyperpolarization. This results in central nervous system depression characterized by sedation, anxiolysis, and muscle relaxation. The intranasal formulation provides rapid onset of action suitable for acute anxiety and seizure management.
Approved indications
- Acute seizure management
- Acute anxiety and agitation
- Procedural sedation
Common side effects
- Sedation
- Drowsiness
- Headache
- Nasal irritation
- Respiratory depression
Key clinical trials
- Management of Catatonic Features in Adolescents With Profound Autism (NA)
- A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder (PHASE3)
- Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children (PHASE4)
- Pediatric Dose Optimization for Seizures in Emergency Medical Services (PHASE3)
- Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old) (NA)
- Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room (PHASE2)
- Administration of Intranasal Midazolam for Anxiety in Palliative Care (PHASE2)
- Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Intranasal Midazolam CI brief — competitive landscape report
- Intranasal Midazolam updates RSS · CI watch RSS
- Hamad Medical Corporation portfolio CI