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Midazolam (active placebo)
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 the GABA-A receptor, producing sedation, anxiolysis, and amnesia. Used for Sedation and anxiolysis in perioperative and intensive care settings, Acute seizure management, Preoperative anxiety and sedation.
At a glance
| Generic name | Midazolam (active placebo) |
|---|---|
| Sponsor | Taipei Veterans General Hospital, Taiwan |
| Drug class | Benzodiazepine |
| Target | GABA-A receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology; Anesthesia; 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, muscle relaxation, and anticonvulsant effects. When used as an active placebo in clinical trials, midazolam at sub-therapeutic doses may produce subtle effects that help maintain trial blinding.
Approved indications
- Sedation and anxiolysis in perioperative settings
- Acute anxiety and agitation
- Seizure management
- Preoperative medication
Common side effects
- Sedation
- Dizziness
- Headache
- Respiratory depression
- Amnesia
- Hypotension
- Paradoxical agitation
Key clinical trials
- Ketamine, SGB and Combination Treatment for TBI (PHASE2)
- The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain. (EARLY_PHASE1)
- Ketamine for Methamphetamine Use Disorder (PHASE2)
- A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity (PHASE1)
- Administration of Intranasal Midazolam for Anxiety in Palliative Care (PHASE2)
- Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression (PHASE4)
- Midazolam Efficacy/Safety in Pre-Eclamptic C-Section Sedation (NA)
- Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers (PHASE1)
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:
- Midazolam (active placebo) CI brief — competitive landscape report
- Midazolam (active placebo) updates RSS · CI watch RSS
- Taipei Veterans General Hospital, Taiwan portfolio CI