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

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First Posted Date
2012-08-01
Last Posted Date
2022-04-08
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
156
Registration Number
NCT01655225
Locations
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UCLA Medical Center, Los Angeles, California, United States

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Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States

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Azienda Ospedaliero - Universitaria S. Luigi Gonzaga, Orbassano, Torino, Italy

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Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-07-17
Last Posted Date
2016-11-02
Lead Sponsor
University of Medicine and Dentistry of New Jersey
Target Recruit Count
60
Registration Number
NCT01641653
Locations
🇺🇸

University Hospital, Newark, New Jersey, United States

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Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2012-06-12
Last Posted Date
2017-11-28
Lead Sponsor
Yonsei University
Target Recruit Count
11
Registration Number
NCT01617707
Locations
🇰🇷

Severance hospital, Seoul, Korea, Republic of

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First Posted Date
2012-05-11
Last Posted Date
2020-12-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
39
Registration Number
NCT01596647
Locations
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Comprehensive Cancer Centers, Las Vegas, Nevada, United States

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University of Kansas Cancer Center Medical Center, Kansas City, Kansas, United States

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Henry Ford Hospital Henry Ford, Detroit, Michigan, United States

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First Posted Date
2012-04-26
Last Posted Date
2013-03-22
Lead Sponsor
Sanofi
Target Recruit Count
16
Registration Number
NCT01585623
Locations
🇺🇸

Investigational Site Number 840004, Augusta, Georgia, United States

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Investigational Site Number 840002, Philadelphia, Pennsylvania, United States

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Investigational Site Number 840001, Detroit, Michigan, United States

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First Posted Date
2012-04-04
Last Posted Date
2012-04-04
Lead Sponsor
Inje University
Target Recruit Count
26
Registration Number
NCT01570569

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First Posted Date
2012-03-08
Last Posted Date
2012-03-08
Lead Sponsor
Baskent University
Target Recruit Count
50
Registration Number
NCT01548859
Locations
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Baskent University, Faculty of Medicine, Ankara, Çankaya, Turkey

Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-03-05
Last Posted Date
2016-08-29
Lead Sponsor
Sanofi
Target Recruit Count
16
Registration Number
NCT01544140
Locations
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Research Site, Overland Park, Kansas, United States

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