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 to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers

First Posted Date
2022-06-29
Last Posted Date
2023-01-12
Lead Sponsor
AstraZeneca
Target Recruit Count
59
Registration Number
NCT05438303
Locations
🇺🇸

Research Site, Berlin, New Jersey, United States

QT Distance and P Dispersion in ECG in Patients Having Bronchoscopy in the ICU

First Posted Date
2022-06-28
Last Posted Date
2023-01-31
Lead Sponsor
Abant Izzet Baysal University
Target Recruit Count
40
Registration Number
NCT05434624
Locations
🇹🇷

Abant izzet baysal university, Bolu, Turkey

A Study to Assess the Effect of AZD5462 on the Pharmacokinetics of Midazolam, Rosuvastatin and Digoxin

First Posted Date
2022-05-27
Last Posted Date
2023-12-13
Lead Sponsor
AstraZeneca
Target Recruit Count
32
Registration Number
NCT05395117
Locations
🇺🇸

Research Site, Brooklyn, Maryland, United States

A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2022-05-27
Last Posted Date
2023-12-14
Lead Sponsor
Shionogi
Target Recruit Count
14
Registration Number
NCT05395104
Locations
🇺🇸

Worldwide Clinical Trials, San Antonio, Texas, United States

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2022-05-26
Last Posted Date
2023-07-06
Lead Sponsor
ViiV Healthcare
Target Recruit Count
73
Registration Number
NCT05393271
Locations
🇺🇸

GSK Investigational Site, Austin, Texas, United States

Ketamine for Multiple Sclerosis Fatigue

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2022-05-18
Last Posted Date
2024-01-12
Lead Sponsor
Johns Hopkins University
Target Recruit Count
110
Registration Number
NCT05378100
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

Phase 4
Completed
Conditions
Interventions
First Posted Date
2022-05-12
Last Posted Date
2024-05-01
Lead Sponsor
Cukurova University
Target Recruit Count
80
Registration Number
NCT05371600
Locations
🇹🇷

Department of Anesthesiology, Cukurova University Faculty of Medicine, Adana, Turkey

Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty

Phase 4
Completed
Conditions
Interventions
First Posted Date
2022-05-11
Last Posted Date
2024-01-05
Lead Sponsor
Karaman Training and Research Hospital
Target Recruit Count
120
Registration Number
NCT05369819
Locations
🇹🇷

Karaman Training and Research Hospital, Karaman, Turkey

Effect of Midazolam Premedication on Mask Ventilation Difficulty

Phase 4
Completed
Conditions
Interventions
First Posted Date
2022-05-10
Last Posted Date
2022-12-08
Lead Sponsor
Karaman Training and Research Hospital
Target Recruit Count
120
Registration Number
NCT05368441
Locations
🇹🇷

Karaman Training and Research Hospital, Karaman, Turkey

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