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

Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section

First Posted Date
2011-07-28
Last Posted Date
2012-05-17
Lead Sponsor
Qazvin University Of Medical Sciences
Target Recruit Count
90
Registration Number
NCT01404442
Locations
🇮🇷

Qazvin university of medical science, Qazvin, Iran, Islamic Republic of

Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam

First Posted Date
2011-07-26
Last Posted Date
2013-06-20
Lead Sponsor
University of Sao Paulo
Registration Number
NCT01402596
Locations
🇧🇷

University of Sao Paulo, Sao Paulo, SP, Brazil

A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects

First Posted Date
2011-07-26
Last Posted Date
2014-02-17
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT01402076
Locations
🇺🇸

Bio-Kinetic Clinical Applications, Springfield, Missouri, United States

Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients

First Posted Date
2011-07-26
Last Posted Date
2016-02-02
Lead Sponsor
Markus Joerger
Target Recruit Count
54
Registration Number
NCT01402089
Locations
🇨🇭

Cantonal Hospital St.Gallen, St.Gallen, Switzerland

A Study of LY2228820 in Participants With Advanced Cancer

First Posted Date
2011-07-14
Last Posted Date
2020-03-24
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
89
Registration Number
NCT01393990
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Antonio, Texas, United States

Nasogastric Tube Insertion Using Midazolam in the Emergency Department

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-06-17
Last Posted Date
2013-07-22
Lead Sponsor
University of Vermont
Target Recruit Count
49
Registration Number
NCT01375634
Locations
🇺🇸

Fletcher Allen Health Care Emergency Department, Burlington, Vermont, United States

Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2011-06-10
Last Posted Date
2018-01-18
Lead Sponsor
Wayne Goodman MD
Target Recruit Count
3
Registration Number
NCT01371110
Locations
🇺🇸

Clinical Research Centers at Icahn School of Medicine at Mount Sinai, New York, New York, United States

Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

First Posted Date
2011-05-19
Last Posted Date
2011-05-19
Lead Sponsor
Govind Ballabh Pant Hospital
Target Recruit Count
120
Registration Number
NCT01356121
Locations
🇮🇳

Prof Barjesh Chander Sharma, New Delhi, Delhi, India

Cycling of Sedative Infusions in Critically Ill Pediatric Patients

Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2011-04-11
Last Posted Date
2019-01-15
Lead Sponsor
Javier Gelvez, MD
Target Recruit Count
25
Registration Number
NCT01333059
Locations
🇺🇸

Cook Children's Medical Center, Fort Worth, Texas, United States

Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine

First Posted Date
2011-03-07
Last Posted Date
2011-07-12
Lead Sponsor
Helios Research Center
Target Recruit Count
120
Registration Number
NCT01309360
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