Benzodiazepine
Pregnancy: Insufficient data to assess safety in pregnancy. An increased risk of congenital malformation with benzodiazepines in the first trimester has been suggested. High doses in the last trimester, during labour or as an induction agent for caesarean section have produced maternal or fetal adverse effects (maternal inhalation risk, fetal heart rate irregularities, neonatal hypotonia, poor sucking, hypothermia and respiratory depression). Infants of mothers given benzodiazepines chronically in late pregnancy may develop physical dependence and neonatal withdrawal. Midazolam should not be used during pregnancy unless clearly necessary and is preferably avoided for caesarean section. Breast-feeding: midazolam passes in low quantities into breast milk — nursing mothers should discontinue breast-feeding for 24 hours following administration.
Midazolam is a short-acting benzodiazepine used for procedural sedation, premedication, anaesthesia, intensive-care sedation, and (by the buccal route) for prolonged or repeated seizures.
Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.
Adult dose
Dose:Conscious sedation, adults under 60 years: initial dose 2–2.5 mg IV given 5–10 minutes before the beginning of the procedure, administered slowly at a rate of approximately 1 mg/30 seconds; the initial dose may be followed by additional titration doses of 1 mg as necessary; the average total dosage is 3.5–7.5 mg (a total dosage higher than 5 mg is usually not necessary)
Route: Intravenous (the SPC product may also be given intramuscularly or rectally); IV doses must be titrated slowly and never given rapidly or as a bolus injection
Frequency: Titrated — initial dose then 1 mg increments as necessary; onset of action approximately 2 minutes, maximum effect in approximately 5 to 10 minutes
Max: Conscious sedation: total dose 3.5–7.5 mg in adults under 60 years; in adults over 60 years, debilitated or chronically ill patients a total dosage higher than 3.5 mg is usually not necessary
SOURCE: UK SPC (eMC) for Midazolam 1 mg/ml solution for injection/infusion, §4.2 (https://www.medicines.org.uk/emc/product/13192/smpc). CONSCIOUS SEDATION, ADULTS ≥60 YEARS / DEBILITATED / CHRONICALLY ILL: initial dose 0.5–1 mg given 5–10 minutes before the procedure, with additional doses of 0.5–1 mg titrated very slowly as necessary; total dose usually less than 3.5 mg. ANAESTHESIA PREMEDICATION (ASA I–II, under 60 years): 1–2 mg intravenously repeated as necessary, or 0.07–0.1 mg/kg intramuscularly (deep into the muscle mass, 20 to 60 minutes before induction); over 60 years / debilitated / chronically ill: recommended IV initial dose 0.5 mg increased slowly as needed, or IM 0.025–0.05 mg/kg; with concomitant narcotics the midazolam dose should be reduced (usual dosage 2–3 mg). ANAESTHESIA INDUCTION: premedicated adults under 60 years usually 0.15–0.2 mg/kg IV; non-premedicated adults under 60 years 0.3–0.35 mg/kg IV, with additional doses of about 25% of the initial dose if full induction is sought and up to a total of 0.6 mg/kg in refractory cases (higher doses may prolong recovery); premedicated adults over 60 years, debilitated or chronically ill 0.05–0.15 mg/kg IV over 20–30 seconds with a 2-minute wait; non-premedicated adults over 60 years 0.15–0.3 mg/kg; non-premedicated debilitated patients or those with severe systemic disease usually 0.15–0.25 mg/kg. Each induction increment of not more than 5 mg should be injected over 20–30 seconds with 2-minute intervals between doses; if used with other induction agents the initial doses of all medicines should be significantly reduced, sometimes to as low as 25% of the usual initial dose. SEDATIVE COMPONENT IN COMBINED ANAESTHESIA: intermittent IV doses of 0.03–0.1 mg/kg or continuous IV infusion of 0.03–0.1 mg/kg/h, typically with analgesics; lower doses in patients over 60 years, debilitated or chronically ill. SEDATION IN THE INTENSIVE CARE UNIT: IV loading dose 0.03–0.3 mg/kg given slowly in increments — each 1 to 2.5 mg dose over 20–30 seconds with 2-minute intervals — followed by an IV maintenance dose of 0.03–0.2 mg/kg/h; reduce or omit the loading dose and reduce the maintenance dose in patients with hypovolaemia, vasoconstriction or hypothermia; if strong analgesics are co-administered they should be given first; assess sedation level regularly — long-term sedation may lead to tolerance requiring dose increases, and physical dependence with withdrawal symptoms on abrupt cessation. HEPATIC IMPAIRMENT: clearance is reduced with a longer terminal half-life — the required dose may be reduced and vital signs properly monitored. ADMINISTRATION: midazolam should be given only by experienced physicians in a setting fully equipped for monitoring and support of respiratory and cardiovascular function. GAP — this SPC covers IV/IM/rectal use for conscious sedation, premedication, induction, combined anaesthesia and ICU sedation. It does NOT contain a status epilepticus regimen or any buccal (oromucosal) dosing; the '10 mg buccal/IM for status epilepticus' shown on this page must be sourced from a buccal midazolam product SPC or national guidance and verified by the clinician.
Paediatric dose
Route: IV (also IM and rectal)
Frequency: Titrated to effect by indication and age — see notes
Max: Conscious sedation: total dose <6 mg in patients 6 months–5 years; <10 mg in children 6–12 years. Intramuscular: a total dose greater than 10.0 mg is usually not required.
SPC §4.2 gives per-kg paediatric dosing as RANGES, so no single dosePerKg figure can be stated. CONSCIOUS SEDATION — not recommended under 6 months of age (predisposition to airway obstruction and hypoventilation); 6 months to 5 years: initial dose 0.05–0.1 mg/kg IV, up to 0.6 mg/kg may be needed to reach the desired effect but the total dosage should not exceed 6 mg; 6 to 12 years: initial dose 0.025–0.05 mg/kg IV, total dosage may need to reach 0.4 mg/kg with 10 mg as the maximum; 12 to 16 years: use the recommended adult dosages. Rectal (>6 months): total dose usually 0.3–0.5 mg/kg as a single administration — avoid repeated rectal administration. Intramuscular (1–15 years): 0.05–0.15 mg/kg — the IM route should only be used in exceptional cases as it is painful; rectal is preferred. ANAESTHESIA PREMEDICATION (over 6 months): rectal 0.3–0.5 mg/kg 15–30 minutes before induction; intramuscular 0.08–0.2 mg/kg. ICU SEDATION: neonates born before 32 weeks gestation — continuous IV infusion 0.03 mg/kg/h (0.5 micrograms/kg/min); neonates born after 32 weeks gestation and children up to 6 months — 0.06 mg/kg/h (1 microgram/kg/min); IV loading doses are not recommended in preterm infants, neonates and children up to 6 months, the infusion rate should instead be higher during the first hours; children over 6 months (intubated and ventilated) — loading dose 0.05–0.2 mg/kg IV slowly over 2 to 3 minutes, then continuous infusion 0.06–0.12 mg/kg/h (1 to 2 micrograms/kg/min), adjusted generally by 25% of the current rate. In premature infants, neonates and children with body weight below 15 kg, midazolam solutions with a concentration above 1 mg/ml are not recommended — dilute to 1 mg/ml. Careful monitoring of respiratory rate and oxygen saturation is required.
Dose adjustments
Renal
In severe renal impairment (creatinine clearance below 30 ml/min) midazolam may be accompanied by more pronounced and prolonged sedation, possibly including clinically relevant respiratory and cardiovascular depression — dose carefully and titrate to the desired effect. After prolonged infusion in ICU patients with renal failure the mean duration of the sedative effect was considerably increased, most likely due to accumulation of 1'-hydroxy-midazolam glucuronide.
Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.
US labelling (FDA)
Reference — US labelling, may differ from UK
DOSAGE AND ADMINISTRATION 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 …
Source: US FDA prescribing information (openFDA / DailyMed), label dated 2023-12-05. Accessed 2026-06-12. US dosing and indications can differ
from UK practice — use UK sources for prescribing decisions.
Contraindications
Hypersensitivity to midazolam, to benzodiazepines or to any of the excipients
Use for conscious sedation in patients with severe respiratory failure or acute respiratory depression
Sedation (prolonged and postoperative), decreased alertness, somnolence, headache, dizziness, ataxia and anterograde amnesia (duration directly related to the dose)
Paradoxical reactions — restlessness, agitation, irritability, aggressiveness, hallucinations, inappropriate behaviour (reported particularly in children and the elderly)
Physical drug dependence and withdrawal syndrome, including drug withdrawal convulsions; convulsions reported in premature infants and neonates
Strong analgesics given with midazolam should be administered first, so the sedative effect of midazolam can be safely titrated without being confounded by analgesic sedation (SPC §4.2)
Opioids — concomitant use increases the risk of respiratory depression; limit dose and duration and monitor closely (US label)
Other CNS depressants — the sedative effect of IV midazolam is accentuated by narcotics (morphine, pethidine, fentanyl) and also secobarbital and droperidol; adjust the midazolam dose accordingly (US label)
CYP3A4 inhibitors — caution with cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole (US label)
Caution with any medicine having CNS depressant and/or muscle-relaxant properties, particularly in myasthenia gravis (SPC §4.4)
Clinical monograph
How it works
It enhances GABA at the GABA-A receptor, producing rapid sedation, amnesia, anxiolysis and anticonvulsant effects.
Prescribing in practice
Respiratory depression and hypotension can occur, particularly with rapid intravenous injection, in older patients, and with opioids — titrate slowly with resuscitation facilities and flumazenil available.
Reduce the dose in older or frail patients and in hepatic impairment.
Buccal midazolam is a first-line community treatment for prolonged seizures.
Monitoring
Monitor conscious level, oxygen saturation, respiratory rate and blood pressure during sedation.
Counselling the patient
You may not remember the procedure afterwards.
Do not drive or operate machinery and avoid alcohol for the rest of the day after sedation.
Evidence & guidelines
Standard for procedural sedation and premedication, and a first-line community treatment (buccal) for prolonged or repeated seizures.
Reference: RASS/SAT protocols; MENDS Trial (Pandharipande et al, JAMA 2007); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing.
The structured dose values shown have been reviewed by a clinician.
Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.