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
2011-02-15
Last Posted Date
2024-07-31
Lead Sponsor
Genentech, Inc.
Target Recruit Count
674
Registration Number
NCT01296555
Locations
🇺🇸

Univ of Chicago, Chicago, Illinois, United States

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Mary Crowley Cancer Rsch Ctr, Dallas, Texas, United States

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Baylor Sammons Cancer Center, Dallas, Texas, United States

and more 28 locations

BAY73-4506 Probe Substrate Study

First Posted Date
2011-02-01
Last Posted Date
2019-07-10
Lead Sponsor
Bayer
Target Recruit Count
41
Registration Number
NCT01287598
Locations
🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

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Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada

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British Columbia Cancer Agency-Vancouver Centre, Vancouver, British Columbia, Canada

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First Posted Date
2010-12-09
Last Posted Date
2010-12-09
Lead Sponsor
Hospital Sao Domingos
Target Recruit Count
146
Registration Number
NCT01256866
Locations
🇧🇷

Hospital Sao Domingos, Sao Luis, Maranhao, Brazil

The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-10-15
Last Posted Date
2018-08-07
Lead Sponsor
Amgen
Target Recruit Count
30
Registration Number
NCT01221727

Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity Using Metabolomics

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-10-06
Last Posted Date
2011-02-23
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
24
Registration Number
NCT01215214
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

A Tasisulam and Midazolam Drug Interaction Study in Cancer Patients

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2010-09-27
Last Posted Date
2019-03-18
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
11
Registration Number
NCT01209832
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., Rennes, France

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First Posted Date
2010-08-25
Last Posted Date
2014-04-01
Lead Sponsor
Nationwide Children's Hospital
Target Recruit Count
100
Registration Number
NCT01188551
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

A Study to Assess Drug Interaction of ASP015K and Midazolam

First Posted Date
2010-08-16
Last Posted Date
2010-08-16
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
30
Registration Number
NCT01182077

Resveratrol and Midazolam Metabolism

First Posted Date
2010-08-02
Last Posted Date
2017-10-31
Lead Sponsor
University of Washington
Target Recruit Count
6
Registration Number
NCT01173640
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

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