Midazolam
midazolam hydrochloride · Injection, Solution · Intramuscular, Intravenous
Current shortage
Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 25021-655-02) – Unavailable (Gland Pharma Limited, updated Jul 22, 2026)
Estimated recovery: TBD; Distributed by Sagent Pharmaceuticals
Midazolam Hydrochloride, Injection, 25 mg/5 mL (5 mg/mL) (NDC 0409-2596-03) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 25021-661-10) – Unavailable (Gland Pharma Limited, updated Jul 22, 2026)
Estimated recovery: TBD; Distributed by Sagent Pharmaceuticals
Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6059-01) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots are scheduled to be manufactured. Product will be made available as it is released.
Midazolam Hydrochloride, Injection, 10 mg/10 mL (1 mg/mL) (NDC 0409-2587-05) – Unavailable (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Next Delivery and Estimated Recovery: December 2026
Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-411-25) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Check wholesalers for inventory
Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2 mL (NDC 76045-211-20) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Next release October 2026. Check wholesalers for inventory.
Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2mL (1 mg/mL) (NDC 0409-0001-25) – Limited Availability (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Limited Supply Available. Next Delivery and Estimated Recovery: December 2026
Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 63323-412-10) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Estimated recovery: TBD
Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6056-10) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots are scheduled to be manufactured. Product will be made available as it is released.
Uses
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. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
• continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
Dosage and administration
Midazolam injection is a potent sedative agent that requires slow administration and individualization of dosage. Clinical experience has shown midazolam 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 TO WHOM MIDAZOLAM 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 (see WARNINGS ). Midazolam injection should only be administered intramuscularly or intravenously (see WARNINGS ). Care should be taken to avoid intra-arterial injection or extravasation (see WARNINGS ). Midazolam Injection may be mixed in the same syringe with the following frequently used premedications: morphine sulfate, meperidine, atropine sulfate or scopolamine. Midazolam, at a concentration of 0.5 mg/mL, is compatible with 5% dextrose in water and 0.9% sodium chloride for up to 24 hours and with lactated Ringer's solution for up to 4 hours. Both the 1 mg/mL and 5 mg/mL formulations of midazolam may be diluted with 0.9% sodium chloride or 5% dextrose in water. Monitoring : Patient response to sedative agents, and resultant respiratory status, is variable. Regardless of the intended level of sedation or route of administration, sedation is a continuum; a patient may move easily from light to deep sedation, with potential loss of protective reflexes. This is especially true in pediatric patients. Sedative doses should be individually titrated, taking into account patient age, clinical status and concomitant use of other CNS depressants. Continuous monitoring of respiratory and cardiac function is required (i.e., pulse oximetry). Adults and Pediatrics : Sedation guidelines recommend a careful presedation history to determine how a patient's underlying medical conditions or concomitant medications might affect their response to sedation/analgesia as well as a physical examination including a focused examination of the airway for abnormalities. Further recommendations include appropriate presedation fasting. Titration to effect with multiple small doses is essential for safe administration. It should be noted that adequate time to achieve peak central nervous system effect (3 to 5 minutes) for midazolam should be allowed between doses to minimize the potential for oversedation. Sufficient time must elapse between doses of concomitant sedative medications to allow the effect of each dose to be assessed before subsequent drug administration. This is an important consideration for all patients who receive intravenous midazolam. Immediate availability of resuscitative drugs and age- and size-appropriate equipment and personnel trained in their use and skilled in airway management should be assured (see WARNINGS ). Pediatrics : For deeply sedated pediatric patients a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. Intravenous access is not thought to be necessary for all pediatric patients sedated for a diagnostic or therapeutic procedure because in some cases the difficulty of gaining intravenous access would defeat the purpose of sedating the child; rather, emphasis should be placed upon having the intravenous equipment available and a practitioner skilled in establishing vascular access in pediatric patients immediately available. USUAL ADULT DOSAGE INTRAMUSCULARLY For preoperative sedation/anxiolysis/amnesia (induction of sleepiness or drowsiness and relief of apprehension and to impair memory of perioperative events). For intramuscular use, midazolam should be injected deep in a large muscle mass. The recommended premedication dose of midazolam for good risk (ASA Physical Status I & II) adult patients below the age of 60 years is 0.07 to 0.08 mg/kg intramuscular (approximately 5 mg intramuscular) administered up to 1 hour before surgery. The dose must be individualized and reduced when intramuscular midazolam is administered to patients with chronic obstructive pulmonary disease, other higher risk surgical patients, patients 60 or more years of age, and patients who have received concomitant narcotics or other CNS depressants (see ADVERSE REACTIONS ). In a study of patients 60 years or older, who did not receive concomitant administration of narcotics, 2 to 3 mg (0.02 to 0.05 mg/kg) of midazolam produced adequate sedation during the preoperative period. The dose of 1 mg intramuscular midazolam may suffice for some older patients if the anticipated intensity and duration of sedation is less critical. As with any potential respiratory depressant, these patients require observation for signs of cardiorespiratory depression after receiving intramuscular midazolam. Onset is within 15 minutes, peaking at 30 to 60 minutes. It can be administered concomitantly with atropine sulfate or scopolamine and reduced doses of narcotics. INTRAVENOUSLY Sedation/anxiolysis/amnesia for procedures (see INDICATIONS AND USAGE ): Narcotic premedication results in less variability in patient response and a reduction in dosage of midazolam. For peroral procedures, the use of an appropriate topical anesthetic is recommended. For bronchoscopic procedures, the use of narcotic premedication is recommended.
Contraindications
Injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. Benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. Measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam; patients with glaucoma have not been studied.
Warnings
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). Risks from Concomitant Use With Opioids Concomitant use of benzodiazepines, including midazolam, and opioids may result in profound sedation, respiratory depression, coma, and death. If a decision is made to use midazolam concomitantly with opioids, monitor patients closely for respiratory depression and sedation (see PRECAUTIONS; Drug Interactions ). Risk of Respiratory Adverse Events Serious cardiorespiratory adverse events have occurred after administration of midazolam. These have included respiratory depression, airway obstruction, oxygen desaturation, apnea, respiratory arrest and/or cardiac arrest, sometimes resulting in death or permanent neurologic injury. There have also been rare reports of hypotensive episodes requiring treatment during or after diagnostic or surgical manipulations particularly in adult or pediatric patients with hemodynamic instability. Hypotension occurred more frequently in the sedation studies in patients premedicated with a narcotic. Individualization of Dosage Midazolam must never be used without individualization of dosage particularly when used with other medications capable of producing central nervous system depression. See DOSAGE AND ADMINISTRATION for complete information. Other Adverse Events Reactions such as agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity and combativeness have been reported in both adult and pediatric patients. These reactions may be due to inadequate or excessive dosing or improper administration of midazolam; however, consideration should be given to the possibility of cerebral hypoxia or true paradoxical reactions. Should such reactions occur, the response to each dose of midazolam and all other drugs, including local anesthetics, should be evaluated before proceeding. Reversal of such responses with flumazenil has been reported in pediatric patients. Concomitant Use of Central Nervous System Depressants Concomitant use of barbiturates, alcohol or other central nervous system depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect. Narcotic premedication also depresses the ventilatory response to carbon dioxide stimulation. Debilitation and Comorbid Considerations Higher risk adult and pediatric surgical patients, elderly patients and debilitated adult and pediatric patients require lower dosages, whether or not concomitant sedating medications have been administered. Adult or pediatric patients with COPD are unusually sensitive to the respiratory depressant effect of midazolam. Pediatric and adult patients undergoing procedures involving the upper airway such as upper endoscopy or dental care, are particularly vulnerable to episodes of desaturation and hypoventilation due to partial airway obstruction. Adult and pediatric patients with chronic renal failure and patients with congestive heart failure eliminate midazolam more slowly (see CLINICAL PHARMACOLOGY ). Because elderly patients frequently have inefficient function of one or more organ systems and because dosage requirements have been shown to decrease with age, reduced initial dosage of midazolam is recommended, and the possibility of profound and/or prolonged effect should be considered. Injectable midazolam should not be administered to adult or pediatric patients in shock or coma, or in acute alcohol intoxication with depression of vital signs. Particular care should be exercised in the use of intravenous midazolam in adult or pediatric patients with uncompensated acute illnesses, such as severe fluid or electrolyte disturbances. Risk of Intra-arterial Injection There have been limited reports of intra-arterial injection of midazolam. Adverse events have included local reactions, as well as isolated reports of seizure activity in which no clear causal relationship was established. Precautions against unintended intra-arterial injection should be taken. Extravasation should also be avoided. The safety and efficacy of midazolam following nonintravenous and nonintramuscular routes of administration have not been established. Midazolam should only be administered intramuscularly or intravenously. Return to Full Cognitive Function Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours.
Precautions
General : Intravenous doses of midazolam should be decreased for elderly and for debilitated patients (see WARNINGS and DOSAGE AND ADMINISTRATION ). These patients will also probably take longer to recover completely after midazolam administration for the induction of anesthesia. Midazolam does not protect against the increase in intracranial pressure or against the heart rate rise and/or blood pressure rise associated with endotracheal intubation under light general anesthesia. The efficacy and safety of midazolam in clinical use are functions of the dose administered, the clinical status of the individual patient, and the use of concomitant medications capable of depressing the CNS. Anticipated effects range from mild sedation to deep levels of sedation virtually equivalent to a state of general anesthesia where the patient may require external support of vital functions. Care must be taken to individualize and carefully titrate the dose of midazolam to the patient's underlying medical/surgical conditions, administer to the desired effect being certain to wait an adequate time for peak CNS effects of both midazolam and concomitant medications, and have the personnel and size-appropriate equipment and facilities available for monitoring and intervention (see Boxed WARNING , WARNINGS and DOSAGE AND ADMINISTRATION ). Practitioners administering midazolam must have the skills necessary to manage reasonably foreseeable adverse effects, particularly skills in airway management. For information regarding withdrawal (see DRUG ABUSE AND DEPENDENCE ). Information for Patients : To assure safe and effective use of benzodiazepines, the following information and instructions should be communicated to the patient when appropriate: 1. Inform your physician about any alcohol consumption and medicine you are now taking, especially blood pressure medication and antibiotics, including drugs you buy without a prescription. Alcohol has an increased effect when consumed with benzodiazepines; therefore, caution should be exercised regarding simultaneous ingestion of alcohol during benzodiazepine treatment. 2. Inform your physician if you are pregnant or are planning to become pregnant. 3. Inform your physician if you are nursing. 4. Patients should be informed of the pharmacological effects of midazolam, such as sedation and amnesia, which in some patients may be profound. The decision as to when patients who have received injectable midazolam, particularly on an outpatient basis, may again engage in activities requiring complete mental alertness, operate hazardous machinery or drive a motor vehicle must be individualized. 5. Patients receiving continuous infusion of midazolam in critical care settings over an extended period of time, may experience symptoms of withdrawal following abrupt discontinuation. 6. Effect of anesthetic and sedation drugs on early brain development: Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs. Pregnancy Advise pregnant females that use of midazolam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome and PRECAUTIONS: Pregnancy ). Instruct patients to inform their healthcare provider if they are pregnant. Nursing Instruct patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed. Instruct breastfeeding patients receiving midazolam to monitor infants for excessive sedation, poor feeding, and poor weight gain, and to seek medical attention if they notice these signs. A lactating woman may consider pumping and discarding breastmilk for at least 4 to 8 hours after receiving midazolam for sedation or anesthesia to minimize drug exposure to a breastfed infant (see PRECAUTIONS: Nursing Mothers ). Drug Interactions : Effect of Concomitant Use of Benzodiazepines and Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Monitor patients closely for respiratory depression and sedation. Other CNS Depressants The sedative effect of intravenous midazolam is accentuated by any concomitantly administered medication, which depresses the central nervous system, particularly opioids (e.g., morphine, meperidine and fentanyl) and also secobarbital and droperidol. Consequently, the dosage of midazolam should be adjusted according to the type and amount of concomitant medications administered and the desired clinical response (see DOSAGE AND ADMINISTRATION ). Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. These drug interactions may result in prolonged sedation due to a decrease in plasma clearance of midazolam. The effect of single oral doses of 800 mg cimetidine and 300 mg ranitidine on steady-state concentrations of oral midazolam was examined in a randomized crossover study (n=8). Cimetidine increased the mean midazolam steady-state concentration from 57 to 71 ng/mL. Ranitidine increased the mean steady-state concentration to 62 ng/mL.
Side effects
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 intravenous and 10.8% of patients following intramuscular administration) and apnea (15.4% of patients following intravenous 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 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 intramuscular Injection site pain (3.7%) induration (0.5%) redness (0.5%) muscle stiffness (0.3%) Administration of intramuscular midazolam 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 ). The following additional adverse reactions were reported subsequent to intravenous administration as a single sedative/anxiolytic/amnestic agent in adult patients: hiccoughs (3.9%) Local effects at the intravenous site nausea (2.8%) tenderness (5.6%) vomiting (2.6%) pain during injection (5.0%) coughing (1.3%) redness (2.6%) "oversedation" (1.6%) induration (1.7%) headache (1.5%) phlebitis (0.4%) drowsiness (1.2%) Pediatric Patients : The following adverse events related to the use of intravenous midazolam in pediatric patients were reported in the medical literature: desaturation 4.6%, apnea 2.8%, hypotension 2.7%, paradoxical reactions 2.0%, hiccough 1.2%, seizure-like activity 1.1% and nystagmus 1.1%. The majority of airway-related events occurred in patients receiving other CNS depressing medications and in patients where midazolam was not used as a single sedating agent. Neonates : For information concerning hypotensive episodes and seizures following the administration of midazolam to neonates (see Boxed WARNING , CONTRAINDICATIONS , WARNINGS and PRECAUTIONS) . Other adverse experiences, observed mainly following intravenous injection as a single sedative/anxiolytic/amnesia agent and occurring at an incidence of <1.0% in adult and pediatric patients, are as follows: Respiratory : Laryngospasm, bronchospasm, dyspnea, hyperventilation, wheezing, shallow respirations, airway obstruction, tachypnea Cardiovascular : Bigeminy, premature ventricular contractions, vasovagal episode, bradycardia, tachycardia, nodal rhythm Gastrointestinal : Acid taste, excessive salivation, retching CNS/Neuromuscular : Retrograde amnesia, euphoria, hallucination, confusion, argumentativeness, nervousness, anxiety, grogginess, restlessness, emergence delirium or agitation, prolonged emergence from anesthesia, dreaming during emergence, sleep disturbance, insomnia, nightmares, athetoid movements, seizure-like activity, ataxia, dizziness, dysphoria, slurred speech, dysphonia, paresthesia Special Senses : Blurred vision, diplopia, nystagmus, pinpoint pupils, cyclic movements of eyelids, visual disturbance, difficulty focusing eyes, ears blocked, loss of balance, light-headedness Integumentary : Hive-like elevation at injection site, swelling or feeling of burning, warmth or coldness at injection site Hypersensitivity : Allergic reactions including anaphylactoid reactions, hives, rash, pruritus Miscellaneous : Yawning, lethargy, chills, weakness, toothache, faint feeling, hematoma
Pregnancy
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 PRECAUTIONS: 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 ) . Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case‑control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. Animal Data Pregnant rats were treated with midazolam using intravenous doses of 0.2, 1, and 4 mg/kg/day (0.09, 0.46, and 1.85 times the human induction dose of 0.35 mg/kg based on body surface area comparisons) during the period of organogenesis (Gestation Day 7 through 15). Midazolam did not cause adverse effects to the fetus at doses of up to 1.85 times the human induction dose. All doses produced slight to moderate ataxia. The high dose produced a 5% decrease in maternal body weight gain compared to control. Pregnant rabbits were treated with midazolam using intravenous doses of 0.2, 0.6, and 2 mg/kg/day (0.09, 0.46, and 1.85 times the human induction dose of 0.35 mg/kg based on body surface area comparisons) during the period of organogenesis (Gestation Day 7 to 18). Midazolam did not cause adverse effects to the fetus at doses of up to 1.85 times the human induction dose. The high dose was associated with findings of ataxia and sedation but no evidence of maternal toxicity. Pregnant rats were administered midazolam using intravenous doses of 0.2, 1, and 4 mg/kg/day (0.09, 0.46, and 1.85 times the human induction dose of 0.35 mg/kg based on body surface area comparisons) during late gestation and through lactation (Gestation Day 15 through Lactation Day 21). All doses produced ataxia. The high dose produced a slight decrease in maternal body weight gain compared to control. There were no clear adverse effects noted in the offspring. The study included no functional assessments of the pups, such as learning and memory testing or reproductive capacity. In a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on Gestation Day 122 increased neuronal apoptosis in the developing brain of the fetus. In other published studies, administration of either isoflurane or propofol for 5 hours on Gestation Day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. With respect to brain development, this time period corresponds to the third trimester of gestation in the human. The clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits ( see WARNINGS, Pediatric Neurotoxicity , PRECAUTIONS, Pediatric Use, and ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY ) . Nursing Mothers Risk Summary There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. Based on data from published studies, midazolam is present in human milk in low levels. There are no data on the effects of midazolam on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for midazolam injection and any potential adverse effects on the breastfed infant from midazolam injection or from the underlying maternal condition. Clinical Considerations Infants exposed to midazolam injection through breast milk should be monitored for sedation, poor feeding and poor weight gain. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment for a range of at least 4 to 8 hours after midazolam administration in order to minimize drug exposure to a breastfed infant.
Pediatric use
Pediatric Use The safety and efficacy of midazolam for sedation/anxiolysis/amnesia following single dose intramuscular administration, intravenously by intermittent injections and continuous infusion have been established in pediatric and neonatal patients. For specific safety monitoring and dosage guidelines (see Boxed WARNING , CLINICAL PHARMACOLOGY , INDICATIONS AND USAGE , WARNINGS , PRECAUTIONS , ADVERSE REACTIONS , OVERDOSAGE and DOSAGE AND ADMINISTRATION) . UNLIKE ADULT PATIENTS, PEDIATRIC PATIENTS GENERALLY RECEIVE INCREMENTS OF MIDAZOLAM ON A MG/KG BASIS. As a group, pediatric patients generally require higher dosages of midazolam (mg/kg) than do adults. Younger (less than six years) pediatric patients may require higher dosages (mg/kg) than older pediatric patients, and may require closer monitoring. In obese PEDIATRIC PATIENTS, the dose should be calculated based on ideal body weight. When midazolam is given in conjunction with opioids or other sedatives, the potential for respiratory depression, airway obstruction, or hypoventilation is increased. The health care practitioner who uses this medication in pediatric patients should be aware of and follow accepted professional guidelines for pediatric sedation appropriate to their situation. Midazolam should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid intravenous administration, particularly, with concomitant use of fentanyl. Animal Data Published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as Midazolam Injection USP, that either block NMDA receptors or potentiate the activity of GABA during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately 3 years of age in humans. In primates, exposure to 3 hours of ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. Data from isoflurane-treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in pregnant women, neonates, and young children who require procedures with the potential risks suggested by the nonclinical data (see WARNINGS, Pediatric Neurotoxicity , PRECAUTIONS, Pregnancy and ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY ).
Geriatric use
Geriatric Use Because geriatric patients may have altered drug distribution and diminished hepatic and/or renal function, reduced doses of midazolam are recommended. Intravenous and intramuscular doses of midazolam should be decreased for elderly and for debilitated patients (see WARNINGS and DOSAGE AND ADMINISTRATION ) and subjects over 70 years of age may be particularly sensitive. These patients will also probably take longer to recover completely after midazolam administration for the induction of anesthesia. Administration of intramuscular and intravenous midazolam to elderly and/or high 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 ). Specific dosing and monitoring guidelines for geriatric patients are provided in the DOSAGE AND ADMINISTRATION section for premedicated patients for sedation/anxiolysis/amnesia following intravenous and intramuscular administration, for induction of anesthesia following intravenous administration and for continuous infusion.
Overdosage
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: Risks from Concomitant Use With Opioids , and Concomitant Use of Central Nervous System Depressants ). 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. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life‑threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage. See the flumazenil injection Prescribing Information. Consider contacting a poison center (1-800-222-1222), poisoncontrol.org , or a medical toxicologist for additional overdosage management recommendations.
Description
Midazolam hydrochloride injection is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is adjusted to approximately 3 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ , is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4 H -imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C 18 H 13 ClFN 3
• HCl, a calculated molecular weight of 362.25 and the following structural formula: Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed-ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form. Midazolam Structural formula Midazolam Open-ring Form pH Dependence of Open-ring Form in Water
How supplied
Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam/ mL : Unit of Sale Concentration NDC 0409-2305-50 Carton of 10 Single-dose Fliptop Vials 5 mg/5 mL (1 mg/mL) Package configurations containing preservative-free midazolam hydrochloride equivalent to 5 mg midazolam/ mL : Unit of Sale Concentration NDC 0409-2308-49 Carton of 10 Single-dose Fliptop Vials 5 mg/mL NDC 0409-2308-50 Carton of 10 Single-dose Fliptop Vials 10 mg/2 mL (5 mg/mL) Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Discard unused portion.
Label text from the FDA structured product label by Hospira, Inc. (revised Aug 12, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Midazolam Hydrochloride in 50 products
Midazolam NDC products (50)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 55154-4743 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Cardinal Health 107, LLC | ANDA · DEA CIV |
| 72572-430 | Midazolam Hydrochloride 1 mg/mL Injection | Civica, Inc. | ANDA · DEA CIV |
| 72572-432 | Midazolam Hydrochloride 1 mg/mL Injection | Civica, Inc. | ANDA · DEA CIV |
| 76045-001 | Midazolam Hydrochloride 2 mg/2mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CIV |
| 63323-412 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CIV |
| 63323-411 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CIV |
| 76045-002 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CIV |
| 76045-003 | Midazolam Hydrochloride 10 mg/2mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CIV |
| 76045-211 | Midazolam Hydrochloride 2 mg/2mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA · DEA CIV |
| 0404-9801 | Midazolam Hydrochloride 5 mg/mL Injection | Henry Schein, Inc. | ANDA · DEA CIV |
| 0404-9780 | Midazolam Hydrochloride 1 mg/mL Injection | Henry Schein, Inc. | ANDA · DEA CIV |
| 0404-9913 | Midazolam Hydrochloride 1 mg/mL Injection | Henry Schein, Inc. | ANDA · DEA CIV |
| 0404-9915 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Henry Schein, Inc. | ANDA · DEA CIV |
| 0641-6060 | Midazolam Hydrochloride 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6056 | Midazolam Hydrochloride 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6057 | Midazolam Hydrochloride 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6281 | Midazolam Hydrochloride 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6220 | Midazolam Hydrochloride 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6219 | Midazolam Hydrochloride 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6218 | Midazolam Hydrochloride 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6211 | Midazolam Hydrochloride 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6210 | Midazolam Hydrochloride 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6209 | Midazolam Hydrochloride 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6190 | Midazolam Hydrochloride 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6063 | Midazolam Hydrochloride 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6061 | Midazolam Hydrochloride 5 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0641-6059 | Midazolam Hydrochloride 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CIV |
| 0409-2596 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIV |
| 0409-2587 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIV |
| 0409-2308 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIV |
| 0409-2305 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIV |
| 0409-0001 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CIV |
| 42571-414 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Micro Labs Limited | ANDA · DEA CIV |
| 42571-415 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Micro Labs Limited | ANDA · DEA CIV |
| 83270-176 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Onesource Specialty Pharma Limited | ANDA · DEA CIV |
| 83270-175 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Onesource Specialty Pharma Limited | ANDA · DEA CIV |
| 83270-174 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Onesource Specialty Pharma Limited | ANDA · DEA CIV |
| 83270-173 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Onesource Specialty Pharma Limited | ANDA · DEA CIV |
| 83270-172 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Onesource Specialty Pharma Limited | ANDA · DEA CIV |
| 83270-170 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Onesource Specialty Pharma Limited | ANDA · DEA CIV |
| 83270-171 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Onesource Specialty Pharma Limited | ANDA · DEA CIV |
| 70518-4328 | Midazolam Hydrochloride 2 mg/2mL Injection, Solution | REMEDYREPACK INC. | ANDA · DEA CIV |
| 25021-661 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA · DEA CIV |
| 25021-655 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA · DEA CIV |
| 70069-818 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | SOMERSET THERAPEUTICS, LLC | ANDA · DEA CIV |
| 70069-816 | Midazolam Hydrochloride 2 mg/2mL Injection, Solution | SOMERSET THERAPEUTICS, LLC | ANDA · DEA CIV |
| 70069-817 | Midazolam Hydrochloride 5 mg/5mL Injection, Solution | SOMERSET THERAPEUTICS, LLC | ANDA · DEA CIV |
| 82449-209 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Steriscience Specialties Private Limited | ANDA · DEA CIV |
| 82449-208 | Midazolam Hydrochloride 5 mg/mL Injection, Solution | Steriscience Specialties Private Limited | ANDA · DEA CIV |
| 82449-207 | Midazolam Hydrochloride 1 mg/mL Injection, Solution | Steriscience Specialties Private Limited | ANDA · DEA CIV |
Midazolam recalls
- D-0152-2018 Jan 10, 2018 · Class I · Terminated
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 - D-0456-2017 Feb 8, 2017 · Class II · Terminated
Failed Impurities/Degradation Specifications - D-0295-2015 Dec 17, 2014 · Class II · Terminated
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Frequently asked questions
What is Midazolam used for?
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…
What are the side effects of Midazolam?
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 intravenous and 10.8% of patients following intramuscular administration) and… See the full label for the complete list.
Who makes Midazolam?
Midazolam is listed by 12 labelers in the FDA NDC directory, including Cardinal Health 107, LLC, Civica, Inc., Fresenius Kabi USA, LLC, Henry Schein, Inc..
Has Midazolam been recalled?
The FDA enforcement database lists 3 recalls for Midazolam, most recently D-0152-2018 (class i): 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