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Midazolam

  • Prescription medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Midazolam does in the body

Making a person calm and drowsy for a procedure, and making sure they do not remember it

The brain has a receptor that lets chloride into neurons and makes them harder to fire; GABA is the chemical that opens it. Midazolam does not open it. It binds a pocket on the side of the receptor and makes each GABA molecule work harder, so wherever the brain is already applying its own brake, the brake bites more. Because the hippocampus is where new memories are laid down, and it is dense with the receptor subtype midazolam works best on, the person stays awake and conversational and forms almost no memory of what happened.

What happened in people

Reversible pH-dependent ring opening giving aqueous solubility below pH 4 and lipophilicity at blood pH

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

Displaced from first-line intensive care sedation by the trials above, and still ubiquitous everywhere a person needs to cooperate with a procedure and not remember it

Where it acts
Interface between the alpha and gamma2 subunits of the GABA-A receptor, on cortical, hippocampal and limbic neurons
Kind of result
A number that stands in for health
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • Its recorded molecular formula is C18H13ClFN3, weighing 325.8.

    US prescribing information · 2b29422e-54d5-4a49-8522-e9cf752368c3 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 129 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Absolute difference

An absolute difference is how many more people in a hundred were affected.

A picture of it, and where the picture fails

It is like counting heads in two rooms of a hundred.

Where that stops being true. Heads are easy to count. Study results carry a margin of error too.

What people get wrong. It is confused with a percentage change, which can look far larger.

The arithmetic difference in event rates between arms.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Absence of seizures on arrival at the emergency department without the need for rescue therapy

The study showed what it set out to show

Who was studied
RAMPART — intramuscular midazolam versus intravenous lorazepam for prehospital status epilepticus
How many people
893
Study design
Double-blind randomised non-inferiority trial
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
73.4% (329/448) with intramuscular midazolam versus 63.4% (282/445) with intravenous lorazepam; absolute difference 10 percentage points, 95% CI 4.0 to 16.1, P<0.001 for both non-inferiority and superiority
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Endotracheal intubation was needed in 14.1% versus 14.4% and seizures recurred in 11.4% versus 10.6% — the advantage is in stopping the seizure faster, not in avoiding intubation.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Sterile aqueous solution for intravenous and intramuscular injection, in single- and multiple-dose vials, premixed infusion bags, prefilled autoinjectors and an oral syrup; buccal and intranasal formulations exist for seizure rescue

Interval reported. 95% CI 4

Written into the record, not signed off as a reviewed claim.

Percentage of time within the target Richmond Agitation-Sedation Scale range

The study did not show it

Who was studied
SEDCOM — dexmedetomidine versus midazolam for sedation of critically ill patients
How many people
375
Study design
Prospective double-blind randomised trial at 68 centres in 5 countries
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Primary endpoint neutral: 75.1% for midazolam versus 77.3% for dexmedetomidine, difference 2.2 percentage points (95% CI -3.2 to 7.5), P=0.18. Delirium 76.6% versus 54%, difference 22.6 points (95% CI 14 to 33), P<0.001; time to extubation 5.6 versus 3.7 days, P=0.01
Repeated elsewhere
Partially Replicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Intensive care length of stay did not differ significantly despite the extubation difference, which is a reminder that a ventilator-day advantage need not translate into a discharge advantage.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Sterile aqueous solution for intravenous and intramuscular injection, in single- and multiple-dose vials, premixed infusion bags, prefilled autoinjectors and an oral syrup; buccal and intranasal formulations exist for seizure rescue

Interval reported. 95% CI -3

Written into the record, not signed off as a reviewed claim.

Sedative, amnesic, anticonvulsant, anxiolytic, myorelaxant and motor effects of diazepam in alpha1(H101R) versus wild-type mice

The study showed what it set out to show

Who was studied
Rudolph alpha1(H101R) knock-in mouse dissociation of benzodiazepine actions
How many people
0
Study design
Genetic knock-in mechanism study
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Sedative, amnesic and partial anticonvulsant actions abolished in the knock-in; anxiolytic-like, myorelaxant, motor-impairing and ethanol-potentiating effects fully retained
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. A mouse study of diazepam rather than midazolam. The subtype attribution is accepted for the benzodiazepine site as a class, but the specific quantitative profile of midazolam across subtypes is not established by this experiment.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Sterile aqueous solution for intravenous and intramuscular injection, in single- and multiple-dose vials, premixed infusion bags, prefilled autoinjectors and an oral syrup; buccal and intranasal formulations exist for seizure rescue

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Midazolam

    What a person takes: Sterile aqueous solution for intravenous and intramuscular injection, in single- and multiple-dose vials, premixed infusion bags, prefilled autoinjectors and an oral syrup; buccal and intranasal formulations exist for seizure rescue.

    The measurement behind this step

    The range of routes is a direct consequence of the pH-dependent ring opening: because the molecule is genuinely water-soluble in an acidic vial, it can be injected intramuscularly, sprayed into a nostril or squirted into a cheek, none of which is practical for a benzodiazepine that needs an organic solvent. That is what made the RAMPART autoinjector trial possible and what underlies community seizure-rescue formulations. Multiple-dose presentations contain benzyl alcohol, which matters in neonates. The label restricts intravenous use to settings with continuous respiratory and cardiac monitoring and airway-skilled personnel immediately available.

  2. Getting in

    Injected as a water-soluble salt with no solvent needed

    In the vial the drug is dissolved in plain acidified water. Older injectable benzodiazepines needed an oily solvent that stung the vein and could damage it.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    At a formulation pH near 3 the fused imidazole ring is open and the molecule is freely water-soluble, so no propylene glycol or similar co-solvent is required. The intramuscular route works for the same reason, which is what made an autoinjector for seizures possible.

  3. Reaching the cell

    In the blood the ring snaps shut and it becomes fat-soluble

    At the pH of blood, the open ring closes again. The molecule turns greasy, crosses into the brain within a couple of minutes, and starts working.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Ring closure at physiological pH restores a lipophilic species that crosses the blood-brain barrier rapidly. This pH-dependent equilibrium is unique among the benzodiazepines in clinical use and is the structural reason midazolam is the injectable one.

  4. What it acts on

    It binds a pocket on the side of the receptor, not the channel itself

    It does not open the chloride gate. It binds the outside of the receptor, at the seam between two subunits, and makes the brain's own GABA work better.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    The benzodiazepine site lies at the interface between an alpha and the gamma2 subunit, distinct from the GABA sites at the beta-alpha interfaces and from propofol's site on the beta subunit. Because midazolam is a positive allosteric modulator with no intrinsic activity, its effect has a ceiling set by how much GABA is present — which is why benzodiazepine overdose alone is far less lethal than barbiturate overdose, and why the addition of an opioid changes that arithmetic entirely.

  5. The change it makes

    The alpha1 subtype delivers the sedation and the amnesia

    Different versions of the receptor sit in different parts of the brain and do different jobs. The version in the cortex and hippocampus is the one that makes you drowsy and stops memories forming.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    The alpha1(H101R) knock-in mouse loses the sedative and amnesic actions of a benzodiazepine while retaining the anxiolytic, myorelaxant and motor-impairing ones, which are attributed to alpha2, alpha3 and alpha5 receptors in limbic, monoaminergic and motoneuron circuits. Dense alpha1 expression in hippocampus is the anatomical basis of anterograde amnesia at doses that leave a patient conversational.

  6. What that does for a person

    Awake, calm, cooperative — and forming no memory

    The patient can answer questions, follow instructions and swallow on request, and afterwards remembers essentially nothing from the moment the drug went in.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Conscious sedation with retained responsiveness and dense anterograde amnesia is the intended clinical state, and it is separable from depth of sedation. Respiratory depression is dose-dependent and is markedly potentiated by opioids acting on brainstem mu receptors, which is why the boxed warning names the combination specifically.

  7. What that does for a person

    Cleared by CYP3A4 — into something that also sedates

    The liver converts it into a compound that is itself active, then attaches a sugar for the kidney to remove. If the kidneys are failing, that form builds up and the sedation goes on.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    CYP3A4 hydroxylation yields 1-hydroxymidazolam, which is active, and glucuronidation yields an active, renally cleared conjugate. Context-sensitive half-time lengthens substantially with infusion duration, so prolonged intensive care sedation does not offset promptly. CYP3A4 inhibitors and inducers alter clearance markedly. Flumazenil competitively displaces midazolam from the receptor but is shorter-acting than the drug it reverses, so resedation must be anticipated.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Anyone having an endoscopy, a cardiac catheterisation, an awake procedure under sedation, an emergency intubation, or treatment for a prolonged seizure; and, historically, most ventilated patients in intensive care.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of NAYZILAM have been evaluated in the age group 12 to 17 years.”

    US prescribing information · 2b29422e-54d5-4a49-8522-e9cf752368c3 · read 2026-08-30

  • On older people, the label states: “Safety and efficacy studies of NAYZILAM did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · 2b29422e-54d5-4a49-8522-e9cf752368c3 · read 2026-08-30

  • On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as NAYZILAM, during pregnancy.”

    US prescribing information · 2b29422e-54d5-4a49-8522-e9cf752368c3 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Midazolam is excreted in human milk.”

    US prescribing information · 2b29422e-54d5-4a49-8522-e9cf752368c3 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Based on a population pharmacokinetic analysis of patients administered NAYZILAM, midazolam and 1-OH midazolam pharmacokinetics are expected to be similar in subjects with mild renal impairment when compared to normal subjects.”

    US prescribing information · 2b29422e-54d5-4a49-8522-e9cf752368c3 · read 2026-08-30

Where the result stopped carrying

  • Midazolam lost the head-to-head against dexmedetomidine on delirium by 22.6 percentage points and on time to extubation by 1.9 days, and is no longer first-line for intensive care sedation in adults
  • Its boxed warning was written because respiratory depression in non-critical-care settings went unrecognised and caused death and hypoxic brain injury
  • Prolonged infusion in the critically ill produces accumulation and delayed emergence that the drug's short single-dose duration does not predict
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Given by a clinician

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Sterile aqueous solution for intravenous and intramuscular injection, in single- and multiple-dose vials, premixed infusion bags, prefilled autoinjectors and an oral syrup; buccal and intranasal formulations exist for seizure rescue

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

The range of routes is a direct consequence of the pH-dependent ring opening: because the molecule is genuinely water-soluble in an acidic vial, it can be injected intramuscularly, sprayed into a nostril or squirted into a cheek, none of which is practical for a benzodiazepine that needs an organic solvent.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold. The rest of the recorded wording: That is what made the RAMPART autoinjector trial possible and what underlies community seizure-rescue formulations. Multiple-dose presentations contain benzyl alcohol, which matters in neonates. The label restricts intravenous use to settings with continuous respiratory and cardiac monitoring and airway-skilled personnel immediately available.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

The boxed warning covers two things. Intravenous midazolam has caused respiratory depression and respiratory arrest, particularly in non-critical-care settings, with death or hypoxic encephalopathy where this was not promptly recognised and treated; use is restricted to settings with continuous respiratory and cardiac monitoring, resuscitation drugs and equipment, and personnel skilled in airway management, with a dedicated observer for deeply sedated children. Separately, concomitant use with opioids may cause profound sedation, respiratory depression, coma and death. Beyond the warning: an active metabolite and an active glucuronide accumulate in renal impairment, clearance is CYP3A4-dependent and heavily interaction-prone, context-sensitive half-time lengthens with infusion duration, paradoxical agitation occurs particularly in children and older people, and flumazenil is shorter-acting than the drug it reverses. No dosing guidance appears on this page.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Sterile aqueous solution for intravenous and intramuscular injection, in single- and multiple-dose vials, premixed infusion bags, prefilled autoinjectors and an oral syrup; buccal and intranasal formulations exist for seizure rescue

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

That is what made the RAMPART autoinjector trial possible and what underlies community seizure-rescue formulations. Multiple-dose presentations contain benzyl alcohol, which matters in neonates. The label restricts intravenous use to settings with continuous respiratory and cardiac monitoring and airway-skilled personnel immediately available.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 95 products list this as an active ingredient in the United States drug directory. 95 of them contain it and nothing else.

    FDA National Drug Code directory · 76045-001 · read 2026-08-29

  • They are sold as injection, injection, solution, powder, spray and syrup, taken intramuscular, intravenous, nasal and oral.

    FDA National Drug Code directory · 76045-001 · read 2026-08-29

  • The regulator's established pharmacologic class for it is benzodiazepine [epc] and benzodiazepines [cs].

    FDA National Drug Code directory · 76045-001 · read 2026-08-29

  • 46 published labels name it as an active ingredient. 46 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 06e4f754-72df-4eb4-aaed-b538524f5277 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 06e4f754-72df-4eb4-aaed-b538524f5277 · read 2026-08-29

  • Nayzilam is nasal at 3 DOSAGE FORMS AND STRENGTHS NAYZILAM is supplied as a single-dose nasal spray unit containing 5 mg of midazolam in 0.1 mL solution., recorded as fda label in effect 2023-01-19 in the United States.

    US prescribing information · 2b29422e-54d5-4a49-8522-e9cf752368c3 · read 2026-08-30

  • Recorded price in US: 0.23431–1.22143 USD per one millilitre, across 18 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Midazolam studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That the absence of complaints from sedated patients indicates the absence of distress, when dense anterograde amnesia is the drug's intended effect

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the benzodiazepine ceiling effect makes the drug safe in combination — the boxed warning exists because opioids depress ventilation by an independent route

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That a plasma midazolam concentration predicts sedation in renal impairment, when an active glucuronide is accumulating that the assay does not see

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the RAMPART result is a pharmacological superiority of midazolam over lorazepam; it is substantially a demonstration that an intramuscular injection is delivered faster than an intravenous line can be sited in a convulsing patient

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Midazolam are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

One amino acid separates the sedation from the anxiety relief
In plain words
Researchers changed a single amino acid in one subunit of the receptor. Mice carrying the change no longer became sedated or amnesic from a benzodiazepine — but the anti-anxiety and muscle-relaxing effects were completely unaffected.
What was measured
Loss of sedative, amnesic and partial anticonvulsant action in alpha1(H101R) knock-in mice, with anxiolytic, myorelaxant and motor effects fully retained
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Rudolph and colleagues introduced a histidine-to-arginine point mutation at position 101 of the murine alpha1 subunit gene, rendering alpha1-type GABA-A receptors — mainly expressed in cortex and thalamus — insensitive to allosteric modulation by benzodiazepine-site ligands while preserving their regulation by GABA itself. The alpha1(H101R) mice failed to show the sedative, amnesic and partly the anticonvulsant actions of diazepam. The anxiolytic-like, myorelaxant, motor-impairing and ethanol-potentiating effects were fully retained, attributed to the non-mutated receptors found in the limbic system (alpha2, alpha5), in monoaminergic neurons (alpha3) and in motoneurons (alpha2, alpha5). This is the experiment that turned "benzodiazepines have several effects" into a map of which receptor subtype in which circuit produces which effect, and it is why midazolam's amnesia is understood as a specific pharmacological action rather than a by-product of sedation.
Source
Rudolph U, Crestani F, Benke D, et al. Benzodiazepine actions mediated by specific gamma-aminobutyric acid(A) receptor subtypes. Nature 1999;401:796-800
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
RAMPART: an injection into the thigh beat a drip into the vein
In plain words
For a person convulsing in the back of an ambulance, getting a drip in is the hard part. A trial of 893 people found an intramuscular injection of midazolam stopped more seizures than intravenous lorazepam — 73.4% against 63.4%.
What was measured
Absence of seizures on arrival at the emergency department without rescue therapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Silbergleit and colleagues ran a double-blind, randomised, non-inferiority trial comparing intramuscular midazolam by autoinjector with intravenous lorazepam, in children and adults in status epilepticus treated by paramedics, whose convulsions had persisted beyond five minutes and who were still convulsing when paramedics arrived. The primary outcome was absence of seizures on arrival at the emergency department without rescue therapy, with a non-inferiority margin of 10 percentage points. Seizures were absent without rescue in 329 of 448 (73.4%) in the intramuscular midazolam group and 282 of 445 (63.4%) in the intravenous lorazepam group — absolute difference 10 percentage points, 95% CI 4.0 to 16.1, P<0.001 for both non-inferiority and superiority. Endotracheal intubation was needed in 14.1% and 14.4%, and seizures recurred in 11.4% and 10.6%. The mechanism of the advantage is logistical rather than pharmacological: an autoinjector into the thigh is delivered faster than intravenous access can be established in a convulsing patient. This is the clearest patient-relevant benefit on this page and it is a route-of-administration result as much as a drug result.
Source
Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med 2012;366:591-600 (RAMPART)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
SEDCOM: three quarters of midazolam-sedated patients became delirious
In plain words
Compared head to head with dexmedetomidine in intensive care, both drugs kept patients at the target sedation level equally well — but 77% of the midazolam group became delirious against 54%, and they stayed on the ventilator nearly two days longer.
What was measured
Prevalence of delirium during treatment and median time to extubation, against a neutral primary endpoint of time in target sedation range
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
SEDCOM was a prospective, double-blind, randomised trial at 68 centres in five countries among 375 medical and surgical intensive care patients expected to need more than 24 hours of mechanical ventilation, comparing dexmedetomidine (n=244) with midazolam (n=122), each titrated to light sedation until extubation or 30 days. The primary endpoint, percentage of time within the target Richmond Agitation-Sedation Scale range, was 75.1% for midazolam against 77.3% for dexmedetomidine — no difference, P=0.18. On the secondary endpoints midazolam lost decisively: delirium prevalence during treatment was 76.6% (93 of 122) against 54% (132 of 244), a difference of 22.6 percentage points, 95% CI 14 to 33, P<0.001; and median time to extubation was 5.6 days against 3.7, a difference of 1.9 days, P=0.01. Intensive care length of stay did not differ significantly. The result did not remove midazolam from the intensive care unit overnight, but it is the principal evidence behind guidelines that now recommend non-benzodiazepine sedation for ventilated adults.
Source
Riker RR, Shehabi Y, Bokesch PM, et al. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA 2009;301:489-499 (SEDCOM)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
A boxed warning written twice: about breathing, and about opioids
In plain words
The label warns that intravenous midazolam has caused respiratory arrest and death when the drop in breathing was not spotted quickly, and separately that combining it with an opioid can cause profound sedation, coma and death.
What was measured
Labelled requirement for continuous respiratory and cardiac monitoring, airway-skilled personnel, and a dedicated observer for deeply sedated children
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The boxed warning states that intravenous midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in non-critical-care settings, and that in some cases where this was not recognised promptly and treated effectively, death or hypoxic encephalopathy has resulted. It restricts intravenous use to hospital or ambulatory settings — including physicians' and dental offices — that provide continuous monitoring of respiratory and cardiac function such as pulse oximetry, with immediate availability of resuscitative drugs, age- and size-appropriate bag-valve-mask and intubation equipment, and personnel trained and skilled in airway management. For deeply sedated paediatric patients it requires a dedicated individual other than the practitioner performing the procedure to monitor the patient throughout. A separate boxed section warns that concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma and death. The pharmacology behind the second warning is that the two drugs depress ventilation through independent mechanisms, so their combined effect exceeds what either produces alone.
Source
FDA-approved US prescribing information for midazolam hydrochloride injection, BOXED WARNING (DailyMed SPL 1abda8b8-48a8-4995-af86-39220d1aa240)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The amnesia is the product, and it is also why harms surface late
In plain words
A drug whose purpose is that you will not remember what happened is a drug whose bad experiences are, by design, unreportable by the person who had them.
What was measured
That the absence of patient-reported harm during midazolam sedation indicates the absence of harm, when anterograde amnesia is the drug's intended effect
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Midazolam is given for procedural sedation specifically because it produces dense anterograde amnesia through alpha1-containing receptors in hippocampus and cortex — an effect the alpha1(H101R) knock-in shows is a distinct pharmacological action rather than a consequence of depth of sedation. The consequence for evidence is structural. Distress, pain, awareness of a difficult procedure, and paradoxical agitation are all events the patient cannot subsequently report, so they must be captured by an observer at the time or not at all. Patient-reported outcome measures, the standard instrument for detecting this class of harm, are inapplicable in principle rather than merely absent. This page does not claim that midazolam causes unreported distress. It records that the drug's central therapeutic effect removes the mechanism by which such distress would ordinarily come to light, and that this is a reason to weight prospective observer-recorded data far more heavily here than in almost any other drug on this file.
Source
Rudolph U et al. Nature 1999;401:796-800 (alpha1 subtype attribution of the amnesic action); FDA-approved US prescribing information for midazolam hydrochloride injection, Indications
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
An active metabolite that accumulates in exactly the wrong patients
In plain words
The liver turns midazolam into a compound that is itself sedating, and then attaches a sugar to it for the kidneys to excrete. In kidney failure that sugar-conjugated form builds up, and it still sedates.
What was measured
Formation of the active metabolite 1-hydroxymidazolam and its renally cleared active glucuronide, with CYP3A4-dependent clearance
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Midazolam is metabolised principally by CYP3A4 to 1-hydroxymidazolam, which is pharmacologically active, and thence to 1-hydroxymidazolam glucuronide, which is renally cleared and which retains sedative activity. In renal impairment the glucuronide accumulates, producing prolonged sedation that a plasma midazolam concentration would not predict. CYP3A4 dependence also makes the drug unusually sensitive to interaction: azole antifungals, macrolides, protease inhibitors and grapefruit juice inhibit it, while rifampicin and other inducers accelerate clearance. Two clinically consequential facts follow. Prolonged infusion produces a context-sensitive half-time that lengthens sharply with duration, unlike propofol's, so an intensive care patient sedated for days does not wake when the infusion stops. And the population in which this matters most — critically ill patients with renal and hepatic dysfunction on multiple interacting drugs — is precisely the population in which midazolam was for decades the default sedative.
Source
FDA-approved US prescribing information for midazolam hydrochloride injection, Clinical Pharmacology and Drug Interactions
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The ring opens in the vial and closes in the patient
In plain words
Benzodiazepines are greasy and do not dissolve in water. Midazolam solves that with a ring that springs open in the acidic vial, making it water-soluble, and snaps shut in the blood, making it fat-soluble enough to enter the brain.
What was measured
Reversible pH-dependent ring opening of the fused imidazole, giving aqueous solubility below pH 4 and lipophilicity at physiological pH
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The fused imidazole ring of midazolam undergoes reversible, pH-dependent ring opening. In the injection, formulated at a pH near 3, the ring is open and the molecule is a freely water-soluble salt requiring no organic co-solvent — which is why midazolam injection does not cause the venous irritation that propylene-glycol-solubilised diazepam does. On entering blood at pH 7.4 the ring closes, restoring a lipophilic molecule that crosses the blood-brain barrier rapidly. This single structural feature is the reason midazolam displaced diazepam for intravenous and intramuscular use, and it is a genuine formulation achievement built into the molecule rather than into the vehicle. It is on this page as a measured physicochemical property because it is the mechanistic answer to why this benzodiazepine and not another became the injectable standard.
Source
FDA-approved US prescribing information for midazolam hydrochloride injection, Description and Clinical Pharmacology; PubChem CID 4192
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 42 documents were read for this substance.

    RNAWiki source record

  • 26 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

  1. Withdrawn in United States, 2017, for "Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL" (openFDA drug enforcement Class I recall)

What the approval register records

  • 47 approved applications cover products containing this substance. The earliest was NDA018654, approved 19851220 to HLR.

    Drugs@FDA application register · NDA018654 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA018654 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19961003.

    FDA National Drug Code directory · 76045-001 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

7 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A water-soluble benzodiazepine that potentiates the GABA-A receptor at the alpha-gamma interface — proved to sedate through the alpha1 subtype by a single histidine-to-arginine substitution that abolishes the effect in mice — and whose clearest patient benefit is a stopped seizure: 73.4% of 448 people in status epilepticus were seizure-free on arrival at hospital after an intramuscular injection, against 63.4% of 445 given intravenous lorazepam.

Recorded evidence blocks (10)

On the Midazolam label: indicated for what?


"Midazolam injection is indicated: • intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; • intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography,…": indications and usage on Midazolam's label. DailyMed label · 1abda8b8-48a8-4995-af86-39220d1aa240 · 2026-08-12

910 registered trials of Midazolam — at which phases?


Registered studies posting no result
721 of 910

910 registered studies of Midazolam: 387 phase1, 200 phase4, 145 na, 89 phase3, 88 phase2, 21 na or unstated, 17 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

4226 with a PubMed record

Show the evidence
  • phase1
    387
  • phase4
    200
  • na
    145
  • phase3
    89
  • phase2
    88
  • na or unstated
    21
10 more recorded rows
  • early phase1
    17
  • completed
    628
  • unknown
    102
  • terminated
    59
  • recruiting
    45
  • withdrawn
    28
  • not yet recruiting
    24
  • active not recruiting
    16
  • enrolling by invitation
    4
  • suspended
    4

recorded 2026-09-01 · last checked 2026-09-04

75 of Midazolam's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (12), futility/efficacy (3), accrual/recruitment (20), funding/business (10), sponsor decision unspecified (2) and other (28): Midazolam's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"2 complications with midazolam"; 75 of 910 registered studies

Show the evidence

Trial

  • NCT00290082
    terminated; "2 complications with midazolam"
  • NCT00871039
    withdrawn; "Due to logistical purposes"
  • NCT00894465
    terminated; "Most pts requested to be treated with versed. It was difficult to randomize pts."
  • NCT00928772
    terminated; "Lack of efficacy"
  • NCT00947791
    terminated; "Change in available resources for study procedures"
  • NCT01017237
    terminated; "Protocol proved to be ineffective for adequate sedation for third molar surgery."
14 further recorded trials
  • NCT01059929
    terminated; "drug and placebo unavailable"
  • NCT01195103
    terminated; "Funding terminated by funding source."
  • NCT01209832
    terminated; "Terminated based on safety results from another trial"
  • NCT01296555
    terminated; "The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability."
  • NCT01315158
    terminated; "\- The research team is not able to obtain the necessary support to continue the study."
  • NCT01316445
    terminated; "Funding agency no longer provide support."
  • NCT01333059
    terminated; "Unable to adequately enroll over a reasonable enrollment period."
  • NCT01371110
    terminated; "no funding"
  • NCT01402596
    withdrawn; "Institution decided on starting a new protocol of sedation, with another methods and that´s why this study has not started."
  • NCT01535937
    terminated; "An analysis demonstrated that running the final participants was unnecessary."
  • NCT01617707
    terminated; "because of difficulties for participants enrollment"
  • NCT01687751
    withdrawn; "Study design determined to be not likely feasible"
  • NCT01712477
    terminated; "Difficulty in recruiting"
  • NCT01744184
    terminated; "Resource issues, Poor recruitment"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Midazolam used Midazolam (2mg) — over how long?


studies of Midazolam used the recorded amount. ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; also "Midazolam (2mg)", "Midazolam + PF-03716539 (100 mg)", "Midazolam + PF-03716539 (50 mg)"

Show the evidence

human

  • NCT00741468
    Midazolam (2mg)
  • NCT00783484
    Midazolam + PF-03716539 (100 mg)
  • NCT00783484
    Midazolam + PF-03716539 (50 mg)
  • NCT00930306
    Midazolam Tablet, 7.5 mg
  • NCT00987038
    Midazolam 2 mg
  • NCT00990821
    100 MK-0517 (PS80) + 2 mg midazolam
14 more recorded rows
  • human NCT00990821
    2 mg Midazolam
  • human NCT01489943
    Midazolam 3 mg
  • human NCT01535937
    midazolam 0.025 mg/kg
  • human NCT01731067
    midazolam 1 mg
  • human NCT01744184
    Midazolam 1mg/ml Solution for Injection
  • human NCT02056743
    Midazolam 7.5mg
  • human NCT02177955
    7.5 mg Midazolam
  • human NCT02438072
    Midazolam (1 mg, N05CD08)
  • human NCT02445599
    Dormicum 5mg/ml
  • human NCT02887443
    Midazolam 2,5 mg
  • human NCT02909049
    MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319
  • human NCT03089866
    Midazolam (0.02mg/kg)
  • human NCT03458078
    Midazolam 5 MG/ML Injection
  • human NCT03601091
    DORMICUM 5MG/5 ML

recorded 2026-09-01 · last checked 2026-09-04

Midazolam's half-life is 1.8 to 6.4 hours — which schedules were studied?


1.8 to 6.4 hours, the half-life Midazolam's label states: "Six single-dose pharmacokinetic studies involving healthy adults yield pharmacokinetic parameters for midazolam in the following ranges: volume of distribution (Vd), 1.0 to 3.1 L/kg; elimination half-life, 1.8 to 6.4 hours (mean approximately 3 hours); total clearance (Cl), 0.25 to 0.54 L/hr/kg." DailyMed label · 1abda8b8-48a8-4995-af86-39220d1aa240 · 2026-08-12

tmax 0.5 hour; bioavailability 90 %.

Show the evidence
  • half life pharmacokinetics
    1.8 to 6.4 hours; Six single-dose pharmacokinetic studies involving healthy adults yield pharmacokinetic parameters for midazolam in the following ranges: volume of distribution (Vd), 1.0 to 3.1 L/kg; elimination half-life, 1.8 to 6.4 hours (mean approximately 3 hours); total clearance (Cl), 0.25 to 0.54 L/hr/kg.
  • tmax pharmacokinetics
    0.5 hour; The mean peak concentration (C max ) and time to peak (T max ) following the intramuscular dose was 90 ng/mL (20% CV) and 0.5 hour (50% CV).
  • bioavailability pharmacokinetics
    90 %; Absorption : The absolute bioavailability of the intramuscular route was greater than 90% in a cross-over study in which healthy subjects (n=17) were administered a 7.5 mg intravenous or intramuscular dose.
  • metabolism pharmacokinetics
    Elimination of the parent drug takes place via hepatic metabolism of midazolam to hydroxylated metabolites that are conjugated and excreted in the urine.

recorded 2026-08-12 · last checked 2026-09-04

Which running trial of Midazolam could settle lifespan?


NCT05646862 measures Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS), reading out 2029-03-30.

1 open trial; n 420; "A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or…"

Show the evidence
  • Trial NCT05646862
    "A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy"; n 420; "Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)"; 2029-03-30

Which 398 trials of Midazolam posted no result?


Posted no result
398 of 398 completed trials
Registrations
NCT00004424, NCT00188227, NCT00417664, NCT00261261, NCT00125424 and NCT00596414, and 392 more
Completion dates
oldest 2000-03; newest 2024-08-30
Show the evidence

Trial

  • NCT00004424
    2000-03
  • NCT00188227
    2003-11
  • NCT00417664
    2004-04
  • NCT00261261
    2004-12
  • NCT00125424
    2005-09
  • NCT00596414
    2005-10
14 further recorded trials
  • NCT00534378
    2006-12
  • NCT00609960
    2007-01
  • NCT00258050
    2007-02-08
  • NCT00638729
    2007-03
  • NCT00932685
    2007-07
  • NCT00216190
    2007-08
  • NCT00410254
    2007-08
  • NCT01874717
    2007-08
  • NCT00050180
    2007-08-24
  • NCT00109395
    2007-09
  • NCT00839371
    2007-12
  • NCT00511654
    2008-01-11
  • NCT00446420
    2008-02
  • NCT00615212
    2008-02-15

At the median, Midazolam's trials enrolled 54 people — anything larger?


Median enrolment
54
Largest enrolment
11927
Registered trials counted
909

What do 2159 spontaneous reports say about Midazolam — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Midazolam appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2159 reaction mentions were counted: hypotension 532; anaphylactic reaction 233; oxygen saturation decreased 214; tachycardia 214. FAERS via Open Targets · CHEMBL1200420 · 2026-06-24

Show the evidence
  • hypotension
    532
  • anaphylactic reaction
    233
  • oxygen saturation decreased
    214
  • tachycardia
    214
  • seizure
    183
  • status epilepticus
    165
4 more recorded rows
  • bradycardia
    164
  • agitation
    159
  • delirium
    153
  • sedation
    142

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Midazolam's label not list?


agitation, anaphylactic reaction and bradycardia and 7 more reported for Midazolam, absent from its label. FAERS via Open Targets · CHEMBL1200420 · 2026-06-24

3 label terms; 10 reported and unlisted; 2b29422e-54d5-4a49-8522-e9cf752368c3

Show the evidence
  • agitation
    count not stated
  • anaphylactic reaction
    count not stated
  • bradycardia
    count not stated
  • delirium
    count not stated
  • hypotension
    count not stated
  • oxygen saturation decreased
    count not stated
4 more recorded rows
  • sedation
    count not stated
  • seizure
    count not stated
  • status epilepticus
    count not stated
  • tachycardia
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered

Where it’s registered

Withdrawn in United States, 2017, for "Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL" (openFDA drug enforcement Class I recall)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200420
PubChem CID
43032
CAS number
59467-96-8
RxCUI
203128
InChIKey
DDLIGBOFAVUZHB-UHFFFAOYSA-N
Also called
mdz, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM MALEATE, NSC-313452, RO 21-3981/001, RO-213981-003, Midazolam civ, active placebo, adv6209, benzodiazepine, benzodiazepines, buccal midazolam
Trade name
Buccolam, Hypnovel, Seizalam, Versed, Dormicum, Nayzilam, Equidormin, Omforro, Tuzodi
Salt form
Midazolam hcl, Midazolam hydrochloride civ, Midazolam hydrochloride preservative free, Midozalam hydrochloride, Midazolam in 0.8% sodium chloride, Midazolam in 0.9% sodium chloride, midazolam injection, Midazolam in Sodium Chloride, MIDAZOLAM INJECTION, 10 MG, Versed; also marketed as midazolam hydrochloride injection and in sodium chloride
Development code
NSC-751451, RO-213981001, Ro-21-3981-003, SHP-615, SHP615, USL-261, USL261
Sources (8)

Sources

2 more sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work · openFDA enforcement — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 8 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.