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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

Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-03-05
Last Posted Date
2010-09-16
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
38
Registration Number
NCT00856362

Sedation and Pain (The Effect of IV Sedation on Pain Perception)

Not Applicable
Completed
Conditions
Pain
Interventions
First Posted Date
2009-03-02
Last Posted Date
2014-06-26
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
86
Registration Number
NCT00853333
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

Bronchoscopy and Bispectral Index (BIS) - Guided Sedation

Phase 4
Completed
Conditions
Bronchoscopy
Interventions
First Posted Date
2009-02-09
Last Posted Date
2009-02-09
Lead Sponsor
University Hospital, Geneva
Target Recruit Count
84
Registration Number
NCT00839371
Locations
🇨🇭

Centre Valaisan de Pneumologie, Montana, Switzerland

Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-01-16
Last Posted Date
2009-07-31
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT00824057
Locations
🇬🇧

Research Site, London, United Kingdom

The Effect of Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers

Phase 4
Conditions
Hyperalgesia
Interventions
First Posted Date
2008-12-19
Last Posted Date
2009-11-18
Lead Sponsor
Medical University of Vienna
Target Recruit Count
24
Registration Number
NCT00811837
Locations
🇦🇹

Department of Anaesthesia, Medical University of Vienna, Vienna, Austria

To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services

Phase 1
Completed
Conditions
Acute Myocardial Infarction
Pain
Interventions
Other: Course intervention - a professional development course for caregivers.
Drug: Midazolam
First Posted Date
2008-11-17
Last Posted Date
2008-11-17
Lead Sponsor
Sahlgrenska University Hospital, Sweden
Target Recruit Count
2800
Registration Number
NCT00792181

Determine the Effect of Multiple Doses of AZD7325, CYP Study

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2008-11-13
Last Posted Date
2008-11-13
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT00790114

The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers

Phase 4
Conditions
Hyperalgesia
Interventions
First Posted Date
2008-11-11
Last Posted Date
2009-05-21
Lead Sponsor
Medical University of Vienna
Target Recruit Count
24
Registration Number
NCT00789386
Locations
🇦🇹

Department of Anaesthesia, Medical University of Vienna, Vienna, Austria

A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects

First Posted Date
2008-10-31
Last Posted Date
2009-06-02
Lead Sponsor
Pfizer
Target Recruit Count
37
Registration Number
NCT00783484
Locations
🇧🇪

Pfizer Investigational Site, Bruxelles, Belgium

Optimization of IV Ketamine for Treatment Resistant Depression

Phase 2
Completed
Conditions
Major Depressive Disorder (MDD)
Treatment Resistant Depression (TRD)
Interventions
First Posted Date
2008-10-08
Last Posted Date
2014-01-31
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
73
Registration Number
NCT00768430
Locations
🇺🇸

Michael E. Dabakey VA Medical Center & Baylor College of Medicine, Houston, Texas, United States

🇺🇸

Mount Sinai School of Medicine, New York, New York, United States

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