pharmacopeia
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/api/v1/drug/midazolam

Boxed warning

Personnel and Equipment for Monitoring and Resuscitation Adults and Pediatrics: Intravenous midazolam hydrochloride has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Intravenous midazolam hydrochloride should be used only in hospital or ambulatory care settings, including physicians' and dental offices, that provide for continuous monitoring of respiratory and cardiac function, e.g., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured (see WARNINGS ). For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. Risks From Concomitant Use With Opioids Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation (see WARNINGS and PRECAUTIONS ; Drug Interactions ). Individualization of Dosage Midazolam hydrochloride must never be used without individualization of dosage.

Mechanism of action

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Mechanism-of-action class: GABA A Modulators.

GABA A

Indications

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  • 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, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time.

Contraindications

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  • Midazolam injection is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma.contraindicated

Dosage & administration

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Note: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS , Pediatric Use ) Midazolam hydrochloride injection is a potent sedative agent that requires slow administration and individualization of dosage. Clinical experience has shown midazolam hydrochloride to be 3 to 4 times as potent per mg as diazepam. BECAUSE SERIOUS AND LIFE-THREATENING CARDIORESPIRATORY ADVERSE EVENTS HAVE BEEN REPORTED, PROVISION FOR MONITORING, DETECTION AND CORRECTION OF THESE REACTIONS MUST BE MADE FOR EVERY PATIENT T0 WHOM MIDAZOLAM HYDROCHLORIDE INJECTION IS ADMINISTERED, REGARDLESS OF AGE OR HEALTH STATUS. Excessive single doses or rapid intravenous administration may result in respiratory depression, airway obstruction and/or arrest. The potential for these latter effects is increased in debilitated patients, those receiving concomitant medications capable of depressing the CNS, and patients without an endotracheal tube but undergoing a procedure involving the upper airway such as endoscopy or dental (see Boxed WARNING and WARNINGS ). Reactions such as agitation, involuntary movements, hyperactivity and combativeness have been reported in adult and pediatric patients. Should such reactions occur, caution should be exercised before continuing administration of midazolam hydrochloride (see WARNINGS ). Midazolam hydrochloride injection should only be administered IM or IV (see WARNINGS ). Care should be taken to avoid intra-arterial injection or extravasation (see WARNINGS ).

Warnings & precautions

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Personnel and Equipment for Monitoring and Resuscitation Prior to the intravenous administration of midazolam in any dose, the immediate availability of oxygen, resuscitative drugs, age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and skilled personnel for the maintenance of a patent airway and support of ventilation should be ensured. Patients should be continuously monitored for early signs of hypoventilation, airway obstruction, or apnea with means readily available (e.g., pulse oximetry). Hypoventilation, airway obstruction, and apnea can lead to hypoxia and/or cardiac arrest unless effective countermeasures are taken immediately. The immediate availability of specific reversal agents (flumazenil) is highly recommended. Vital signs should continue to be monitored during the recovery period. Because intravenous midazolam can depress respiration (see CLINICAL PHARMACOLOGY ), especially when used concomitantly with opioid agonists and other sedatives (see DOSAGE AND ADMINISTRATION ), it should be used for sedation/anxiolysis/amnesia only in the presence of personnel skilled in early detection of hypoventilation, maintaining a patent airway, and supporting ventilation. When used for sedation/anxiolysis/amnesia, midazolam should always be titrated slowly in adult or pediatric patients. Adverse hemodynamic events have been reported in pediatric patients with cardiovascular instability; rapid intravenous administration should also be avoided in this population (see DOSAGE AND ADMINISTRATION for complete information).

Adverse reactions

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See WARNINGS concerning serious cardiorespiratory events and possible paradoxical reactions. Fluctuations in vital signs were the most frequently seen findings following parenteral administration of midazolam in adults and included decreased tidal volume and/or respiratory rate decrease (23.3% of patients following IV and 10.8% of patients following IM administration) and apnea (15.4% of patients following IV administration), as well as variations in blood pressure and pulse rate. The majority of serious adverse effects, particularly those associated with oxygenation and ventilation, have been reported when midazolam hydrochloride is administered with other medications capable of depressing the central nervous system. The incidence of such events is higher in patients undergoing procedures involving the airway without the protective effect of an endotracheal tube, (e.g., upper endoscopy and dental procedures). Adults: The following additional adverse reactions were reported after intramuscular administration: headache (1.3%) Local effects at IM Injection site pain (3.7%) induration (0.5%) redness (0.5%) muscle stiffness (0.3%) Administration of IM midazolam hydrochloride to elderly and/or higher risk surgical patients has been associated with rare reports of death under circumstances compatible with cardiorespiratory depression. In most of these cases, the patients also received other central nervous system depressants capable of depressing respiration, especially narcotics (see DOSAGE AND ADMINISTRATION ).

Use in specific populations

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Pregnancy: Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome, and Clinical Considerations ). Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Midazolam injection during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems Monitor neonates exposed to Midazolam injection during pregnancy for signs of withdrawal. Manage these neonates accordingly (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome ).

Pharmacokinetics

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Metabolism
Midazolam's activity is primarily due to the parent drug. Elimination of the parent drug takes place via hepatic metabolism of midazolam to hydroxylated metabolites that are conjugated and excreted in the urine.

Overdosage

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Clinical Presentation Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Abuse, Misuse, and Addiction). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. Management of Overdose In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway maintenance.

Approval history

Sourced from openFDA
  • Jun 20, 2000ANDAANDA075154Fresenius Kabi Usa
  • Jun 20, 2000ANDAANDA075243Hikma
  • Jun 20, 2000ANDAANDA075293Hospira
  • Apr 30, 2002ANDAANDA075873Hikma
  • Jul 22, 2002ANDAANDA075857Hospira
  • May 17, 2019NDANDA211321Ucb Inc
  • Mar 22, 2021NDANDA211844Inforlife
  • Aug 8, 2022NDANDA216359Rafa Labs Ltd

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6056-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6057-25)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6059-01)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 0641-6060-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 0641-6061-25)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Midazolam In 0.9% Sodium Chloride, Injection, 1 mg/1 mL (NDC 44567-610-10)Active
    Sponsor: WG Critical Care
    Updated
  • Midazolam In 0.9% Sodium Chloride, Injection, 1 mg/1 mL (NDC 44567-611-10)Active
    Sponsor: WG Critical Care
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
28,676 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3,42412%
  2. 2Off Label Use2,5568.9%
  3. 3Seizure1,6095.6%
  4. 4Hypotension1,5535.4%
  5. 5Drug Interaction1,2384.3%
  6. 6Death1,1023.8%
  7. 7Pyrexia9773.4%
  8. 8Toxicity To Various Agents9333.3%
  9. 9Cardiac Arrest9293.2%
  10. 10Acute Kidney Injury9153.2%
  11. 11Condition Aggravated7402.6%
  12. 12Nausea7122.5%
  13. 13Respiratory Failure7042.5%
  14. 14Status Epilepticus6972.4%
  15. 15Product Use In Unapproved Indication6792.4%

Literature

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Recent PubMed references pinned to Midazolam as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,725 ClinicalTrials.gov registrations naming Midazolam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Midazolam. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP3A5CPIC C/D (provisional)ClinPGx 3

Frequently asked questions

How does Midazolam work?
Mechanism-of-action class: GABA A Modulators.
What is Midazolam used for?
According to FDA labeling, Midazolam carries indications including: 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, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Midazolam?
Midazolam is classified as Benzodiazepine derivatives, Benzodiazepine, GABA A Modulators, Increased Central Nervous System GABA Activity.
What are the brand names for Midazolam?
Midazolam is marketed under brand names including Nayzilam.
What are the contraindications for Midazolam?
Midazolam labeling lists contraindications including: Midazolam injection is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma.. Always consult the full prescribing information and a clinician.
Note. Data for midazolam is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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