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Buccal midazolam
Buccal midazolam is a Benzodiazepine Small molecule drug developed by Hamad Medical Corporation. It is currently FDA-approved for Acute seizure management, particularly in pediatric patients, Pre-procedural sedation and anxiolysis, Acute agitation and anxiety.
Buccal midazolam is a benzodiazepine that enhances inhibitory GABAergic neurotransmission in the central nervous system to produce sedation and anxiolysis.
Buccal midazolam is a benzodiazepine that enhances inhibitory GABAergic neurotransmission in the central nervous system to produce sedation and anxiolysis. Used for Acute seizure management, particularly in pediatric patients, Pre-procedural sedation and anxiolysis, Acute agitation and anxiety.
At a glance
| Generic name | Buccal midazolam |
|---|---|
| Sponsor | Hamad Medical Corporation |
| Drug class | Benzodiazepine |
| Target | GABA-A receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology, Anesthesia |
| Phase | FDA-approved |
Mechanism of action
Midazolam binds to benzodiazepine receptors on GABA-A channels, increasing chloride influx and hyperpolarizing neurons, which reduces neuronal excitability. The buccal formulation allows rapid absorption through the oral mucosa, providing faster onset than oral administration. This is particularly useful for acute seizure management and pre-procedural sedation in settings where intravenous access is unavailable or undesirable.
Approved indications
- Acute seizure management, particularly in pediatric patients
- Pre-procedural sedation and anxiolysis
- Acute agitation and anxiety
Common side effects
- Sedation
- Drowsiness
- Headache
- Respiratory depression
- Hypotension
Key clinical trials
- A Survey of Midazolam in People With Status Epilepticus
- Acute Agitation in Emergency Psychiatry (PHASE2, PHASE3)
- Improving Status Epilepticus Treatment Times (NA)
- Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center (NA)
- Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair (NA)
- Intranasal vs Buccal vs Intramuscular Midazolam for the Home and Emergency Treatment of Acute Seizures (PHASE4)
- Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting (PHASE3)
- Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients (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:
- Buccal midazolam CI brief — competitive landscape report
- Buccal midazolam updates RSS · CI watch RSS
- Hamad Medical Corporation portfolio CI
Frequently asked questions about Buccal midazolam
What is Buccal midazolam?
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Related
- Drug class: All Benzodiazepine drugs
- Target: All drugs targeting GABA-A receptor
- Manufacturer: Hamad Medical Corporation — full pipeline
- Therapeutic area: All drugs in Neurology, Anesthesia
- Indication: Drugs for Acute seizure management, particularly in pediatric patients
- Indication: Drugs for Pre-procedural sedation and anxiolysis
- Indication: Drugs for Acute agitation and anxiety
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing