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 of Midazolam in Healthy Adults

First Posted Date
2020-12-22
Last Posted Date
2022-03-17
Lead Sponsor
Rafa Laboratories
Target Recruit Count
40
Registration Number
NCT04679623
Locations
🇺🇸

Wake Research, Raleigh, North Carolina, United States

Dexmedetomidine Facilitate Analgesia

First Posted Date
2020-12-19
Last Posted Date
2021-08-05
Lead Sponsor
China International Neuroscience Institution
Target Recruit Count
181
Registration Number
NCT04675372
Locations
🇨🇳

China International Neuroscience, Beijing, Beijing, China

Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

First Posted Date
2020-12-03
Last Posted Date
2023-04-20
Lead Sponsor
Tanta University
Target Recruit Count
60
Registration Number
NCT04652661
Locations
🇪🇬

Tanta University Hospitals, Tanta, ElGharbiaa, Egypt

Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-11-09
Last Posted Date
2023-12-01
Lead Sponsor
Pfizer
Target Recruit Count
16
Registration Number
NCT04621227
Locations
🇺🇸

Anaheim Clinical Trials, LLC, Anaheim, California, United States

Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

First Posted Date
2020-10-26
Last Posted Date
2022-03-15
Lead Sponsor
Peking University
Target Recruit Count
81
Registration Number
NCT04602845
Locations
🇨🇳

Peking University Hospital of Stomatology, Beijing, Beijing, China

🇨🇳

Zijian Guo, Haidian, Beijing, China

Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

First Posted Date
2020-10-22
Last Posted Date
2023-01-10
Lead Sponsor
National Cancer Institute, Egypt
Target Recruit Count
75
Registration Number
NCT04597268
Locations
🇪🇬

Walaa Y Elsabeeny, Cairo, Egypt

Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

First Posted Date
2020-10-22
Last Posted Date
2022-03-15
Lead Sponsor
Peking University
Target Recruit Count
48
Registration Number
NCT04597320
Locations
🇨🇳

Peking University Hospital of Stomatology, Beijing, Beijing, China

A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants

First Posted Date
2020-10-14
Last Posted Date
2022-12-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
104
Registration Number
NCT04586920
Locations
🇺🇸

Anaheim Clinical Trials, LLC, Anaheim, California, United States

🇺🇸

Covance Dallas, Dallas, Texas, United States

Ketamine-enhanced Prolonged Exposure Therapy in PTSD

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2020-09-23
Last Posted Date
2024-12-13
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
100
Registration Number
NCT04560660
Locations
🇺🇸

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, United States

A Study of LY3522348 in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-09-23
Last Posted Date
2021-09-05
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
65
Registration Number
NCT04559568
Locations
🇺🇸

Covance Clinical Research Inc, Daytona Beach, Florida, United States

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