Midazolam

Generic Name
Midazolam
Brand Names
Buccolam, Busulfex, Nayzilam, Seizalam
Drug Type
Small Molecule
Chemical Formula
C18H13ClFN3
CAS Number
59467-70-8
Unique Ingredient Identifier
R60L0SM5BC
Background

Midazolam is a short-acting hypnotic-sedative drug with anxiolytic, muscle relaxant, anticonvulsant, sedative, hypnotic, and amnesic properties. It belongs to a class of drugs called benzodiazepines. This drug is unique from others in this class due to its rapid onset of effects and short duration of action. Midazolam is available by oral, rectal, intranasal, intramuscular (IM), and intravenous (IV) routes and has been used in various biomedical applications, including dentistry, cardiac surgery, and endoscopic procedures as pre-anesthetic medication, and as an adjunct to local anesthesia.

This drug was initially approved by the US FDA in 1985, and has been approved for various indications since. In late 2018, the intramuscular preparation was approved by the FDA for the treatment of status epilepticus in adults. In May 2019, the nasal spray of midazolam was approved for the acute treatment of distinctive intermittent, stereotypic seizure episodes in patients 12 years of age and older. Midazolam is considered a schedule IV drug in the United States due to the low potential for abuse and low risk of dependence.

Indication

Midazolam has different indications depending on its formulation by the FDA.

Nasal

For the nasal spray formulation, midazolam is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.

Intravenous

For the intravenous injection formulation, midazolam is indicated as an agent for sedation/anxiolysis/amnesia and prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants. The sedative, anxiolytic and amnestic use of midazolam can also be employed pre-operatively. It can also be indicated for induction of general anesthesia, before administration of other anesthetic agents or as a component of intravenous supplementation of nitrous oxide and oxygen for a balanced anesthesia. A relatively narrower dose range of midazolam and a shorter period of induction can be achieved if midazolam is combined with narcotic premedication. Finally, midazolam can be indicated as a continous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.

Intramuscular

For the intramusuclar injection formulation, midazolam is indicated for preoperative sedation/anxiolysis/amnesia or for treatment of status epilepticus in adults.

Oral

Midazolam syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. It is only approved in monitored settings only and not for chronic or home use.

In Europe, a buccal formulation of midazolam is also approved for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years). For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.

Associated Conditions
Epileptic seizure, Status Epilepticus
Associated Therapies
Anaesthesia, Anxiolytic therapy therapy, Sedation for mechanically-ventilated patients, Preoperative amnesia therapy, Preoperative sedation therapy

Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2011-12-29
Last Posted Date
2019-07-24
Lead Sponsor
Catholic Health East
Target Recruit Count
10
Registration Number
NCT01501123
Locations
🇺🇸

Mercy Catholic Medical Center, Darby, Pennsylvania, United States

Comparison of Remifentanil With Dexmedetomidine or Midazolam in Regards of Sedation Effectivity and Postoperative Cognitive Functions in Cystoscopies

Not Applicable
Completed
Conditions
First Posted Date
2011-12-13
Last Posted Date
2011-12-13
Lead Sponsor
Gazi University
Target Recruit Count
40
Registration Number
NCT01491009
Locations
🇹🇷

Gazi University Faculty of Medicine Hospital, Ankara, Turkey

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

First Posted Date
2011-12-08
Last Posted Date
2023-05-23
Lead Sponsor
Saint Joseph Mercy Health System
Target Recruit Count
289
Registration Number
NCT01488045
Locations
🇺🇸

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Effect of Sedation on Diagnostic Injections

First Posted Date
2011-11-17
Last Posted Date
2016-12-15
Lead Sponsor
Johns Hopkins University
Target Recruit Count
73
Registration Number
NCT01472835
Locations
🇺🇸

Johns Hopkins Blaustein Pain Treatment Center, Baltimore, Maryland, United States

A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-10-21
Last Posted Date
2020-12-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
79
Registration Number
NCT01456689
Locations
🇪🇸

Novartis Investigative Site, Salamanca, Castilla Y Leon, Spain

The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

First Posted Date
2011-10-03
Last Posted Date
2011-10-03
Lead Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Target Recruit Count
76
Registration Number
NCT01444976
Locations
🇹🇷

Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Bakirkoy, Istanbul, Turkey

Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-09-05
Last Posted Date
2016-05-25
Lead Sponsor
Infante, Javier Molina, M.D.
Target Recruit Count
135
Registration Number
NCT01428882
Locations
🇪🇸

Hospital San Pedro de Alcantara, Caceres, Spain

Drug Interaction Study of Isavuconazole and Midazolam

First Posted Date
2011-08-01
Last Posted Date
2011-08-01
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
24
Registration Number
NCT01406171
Locations
🇺🇸

Covance Clinical Research, Madison, Wisconsin, United States

Study to Examine the Effect of Ulimorelin on the Pharmacokinetics of Midazolam in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-07-29
Last Posted Date
2012-10-16
Lead Sponsor
Norgine
Target Recruit Count
14
Registration Number
NCT01405612
Locations
🇬🇧

BioKinetic Europe Ltd, Belfast, United Kingdom

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