Last reviewed 2026-05-31 · How we verify

Midazolam Mylan

Universitaire Ziekenhuizen KU Leuven · FDA-approved active Small molecule Under review Quality 0/100

Midazolam Mylan is a Benzodiazepine Small molecule drug developed by Universitaire Ziekenhuizen KU Leuven. It is currently FDA-approved for Procedural sedation and anxiolysis, Preoperative anxiolysis, Acute seizure management.

Midazolam is a benzodiazepine that enhances the inhibitory effects of GABA at GABA-A receptors in the central nervous system, producing sedation, anxiolysis, and muscle relaxation.

Midazolam Mylan is a small molecule that acts as a positive allosteric modulator of the GABA-A receptor and anion channel. It has been studied for use in dental care for people with mental disability, as well as for conditions such as respiratory distress syndrome and prematurity of the fetus.

At a glance

Generic name	Midazolam Mylan
Sponsor	Universitaire Ziekenhuizen KU Leuven
Drug class	Benzodiazepine
Target	GABA-A receptor
Modality	Small molecule
Therapeutic area	Central Nervous System / Anesthesia
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 depression of the central nervous system with sedative, anxiolytic, anticonvulsant, and muscle relaxant properties. The drug is commonly used for procedural sedation, preoperative anxiolysis, and acute seizure management.

Approved indications

Procedural sedation and anxiolysis
Preoperative anxiolysis
Acute seizure management
Induction of general anesthesia

Common side effects

Drowsiness
Dizziness
Headache
Respiratory depression
Hypotension
Amnesia

Key clinical trials

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 Mylan CI brief — competitive landscape report
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Frequently asked questions about Midazolam Mylan

What is Midazolam Mylan?

Midazolam Mylan is a Benzodiazepine drug developed by Universitaire Ziekenhuizen KU Leuven, indicated for Procedural sedation and anxiolysis, Preoperative anxiolysis, Acute seizure management.

How does Midazolam Mylan work?

Midazolam is a benzodiazepine that enhances the inhibitory effects of GABA at GABA-A receptors in the central nervous system, producing sedation, anxiolysis, and muscle relaxation.

What is Midazolam Mylan used for?

Midazolam Mylan is indicated for Procedural sedation and anxiolysis, Preoperative anxiolysis, Acute seizure management, Induction of general anesthesia.

Who makes Midazolam Mylan?

Midazolam Mylan is developed and marketed by Universitaire Ziekenhuizen KU Leuven (see full Universitaire Ziekenhuizen KU Leuven pipeline at /company/universitaire-ziekenhuizen-ku-leuven).

What drug class is Midazolam Mylan in?

Midazolam Mylan belongs to the Benzodiazepine class. See all Benzodiazepine drugs at /class/benzodiazepine.

What development phase is Midazolam Mylan in?

Midazolam Mylan is FDA-approved (marketed).

What are the side effects of Midazolam Mylan?

Common side effects of Midazolam Mylan include Drowsiness, Dizziness, Headache, Respiratory depression, Hypotension, Amnesia.

What does Midazolam Mylan target?

Midazolam Mylan targets GABA-A receptor and is a Benzodiazepine.

Drug class: All Benzodiazepine drugs
Target: All drugs targeting GABA-A receptor
Manufacturer: Universitaire Ziekenhuizen KU Leuven — full pipeline
Therapeutic area: All drugs in Central Nervous System / Anesthesia
Indication: Drugs for Procedural sedation and anxiolysis
Indication: Drugs for Preoperative anxiolysis
Indication: Drugs for Acute seizure management

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing