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Benzodiazepine — Short-Acting Sedative 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 foetal adverse effects (maternal inhalation risk, foetal heart rate irregularities, neonatal hypotonia, poor sucking, hypothermia and respiratory depression). 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 — discontinue breast-feeding for 24 hours after administration.

Midazolam (Surgical — Anxiolysis/Sedation)

Brand names: Hypnovel, Buccolam (buccal)

Midazolam is a short-acting intravenous benzodiazepine used surgically for premedication, conscious sedation for procedures, and the induction or maintenance of sedation in anaesthesia and critical care.

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 to 2.5 mg, followed by additional 1 mg titration doses as necessary; average total dose 3.5 to 7.5 mg
Route: Intravenous — slow injection at a rate of approximately 1 mg/30 seconds; never as a rapid or bolus injection. The SPC product is also licensed for intramuscular and rectal use for other indications
Frequency: Titrated to effect — initial dose given 5 to 10 minutes before the start of the procedure, with additional doses as required (onset approx. 2 minutes, maximum effect 5 to 10 minutes)
Max: Conscious sedation: a total dosage higher than 5 mg is usually not necessary in adults under 60 years, and higher than 3.5 mg in patients over 60 years, debilitated or chronically ill patients. No absolute maximum is stated for other indications
SOURCE: eMC UK SPC, 'Midazolam 1 mg/ml solution for injection/infusion', §4.2. Titration is strongly recommended; administer with care in patients over 60, debilitated or chronically ill patients. CONSCIOUS SEDATION, patients over 60 / debilitated / chronically ill: initial 0.5 to 1 mg IV 5 to 10 minutes before the procedure, further 0.5 to 1 mg as necessary, titrated very slowly (peak effect takes longer). ANAESTHESIA PREMEDICATION (ASA I-II, under 60 years): 1 to 2 mg IV repeated as necessary, or 0.07 to 0.1 mg/kg IM 20 to 60 minutes before induction; over 60 / debilitated / chronically ill: 0.5 mg IV initially, slowly increased as needed, or 0.025 to 0.05 mg/kg IM; usual dose 2 to 3 mg with concomitant narcotics (reduce midazolam dose). ANAESTHESIA INDUCTION: premedicated adults under 60 years 0.15 to 0.2 mg/kg IV; non-premedicated adults under 60 years 0.3 to 0.35 mg/kg IV; in refractory cases up to a total of 0.6 mg/kg may be used (may prolong recovery); premedicated adults over 60 / debilitated / chronically ill 0.05 to 0.15 mg/kg IV; non-premedicated over 60 years 0.15 to 0.3 mg/kg; non-premedicated debilitated or severe systemic disease 0.15 to 0.25 mg/kg. Give in increments of not more than 5 mg over 20 to 30 seconds with 2-minute intervals; if used with other induction agents, reduce the initial dose of all agents significantly, sometimes to as low as 25%. SEDATIVE COMPONENT IN COMBINED ANAESTHESIA: intermittent IV doses of 0.03 to 0.1 mg/kg or continuous IV infusion of 0.03 to 0.1 mg/kg/h, typically with analgesics (lower doses in adults over 60, debilitated or chronically ill). ICU SEDATION: IV loading dose 0.03 to 0.3 mg/kg given slowly in increments of 1 to 2.5 mg over 20 to 30 seconds with 2-minute intervals, then maintenance infusion 0.03 to 0.2 mg/kg/h; reduce or omit the loading dose and reduce maintenance in hypovolaemia, vasoconstriction or hypothermia; give strong analgesics first. Hepatic impairment reduces clearance — the required dose may be reduced and vital signs monitored. §4.4 and §4.8 text was truncated at the source-fetch limit.

Paediatric dose

Route: Intravenous (titrated slowly, initial dose over 2 to 3 minutes); rectal or intramuscular for premedication (rectal preferred, IM is painful and only for exceptional cases)
Frequency: Titrated to effect; premedication given 15 to 30 minutes (rectal) before induction
Max: Conscious sedation: total dose must not exceed 6 mg in patients 6 months to 5 years, and 10 mg in children 6 to 12 years. Intramuscular: a total dose greater than 10 mg is usually not required
dosePerKg is left null because the SPC gives DIFFERENT per-kg ranges by age band, route and indication — carrying one number would risk it being applied to the wrong band. CONSCIOUS SEDATION (IV): under 6 months — not recommended (predisposed to airway obstruction and hypoventilation); 6 months to 5 years — initial 0.05 to 0.1 mg/kg, up to 0.6 mg/kg may be needed, total not to exceed 6 mg; 6 to 12 years — initial 0.025 to 0.05 mg/kg, up to a total of 0.4 mg/kg (10 mg maximum); 12 to 16 years — use adult dosages. RECTAL (over 6 months): 0.3 to 0.5 mg/kg total, given at once, not repeated. INTRAMUSCULAR: 0.05 to 0.15 mg/kg (conscious sedation, 1 to 15 years). PREMEDICATION (over 6 months): rectal 0.3 to 0.5 mg/kg 15 to 30 minutes before induction; IM 0.08 to 0.2 mg/kg (1 to 15 years). ICU SEDATION: neonates under 32 weeks gestational age — continuous IV infusion 0.03 mg/kg/h (0.5 micrograms/kg/min); neonates over 32 weeks and children up to 6 months — 0.06 mg/kg/h (1 microgram/kg/min), no IV loading dose in preterm infants, neonates or infants up to 6 months; children over 6 months (intubated and ventilated) — loading dose 0.05 to 0.2 mg/kg IV slowly over 2 to 3 minutes, then continuous infusion 0.06 to 0.12 mg/kg/h (1 to 2 micrograms/kg/min), adjusted by about 25% steps as required. In premature infants, neonates and children under 15 kg, solutions more concentrated than 1 mg/ml are not recommended — dilute to 1 mg/ml. Verify all under-18 dosing against a children's formulary.

Dose adjustments

Renal

In severe renal impairment (creatinine clearance below 30 ml/min) sedation may be more pronounced and prolonged, possibly with clinically relevant respiratory and cardiovascular depression — dose carefully and titrate to effect. After prolonged infusion in ICU patients with renal failure the mean duration of 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.

Contraindications

  • Hypersensitivity to midazolam, benzodiazepines or to any of the excipients
  • Use for conscious sedation in patients with severe respiratory failure or acute respiratory depression

Side effects

  • Respiratory depression, apnoea, respiratory arrest, dyspnoea, laryngospasm, hiccups — severe cardiorespiratory events are more likely when the injection is given too rapidly or at high dosage
  • Cardiac arrest, bradycardia, Kounis syndrome; hypotension, vasodilatation, thrombophlebitis, thrombosis
  • Sedation (prolonged and postoperative), decreased alertness, somnolence, headache, dizziness, ataxia, anterograde amnesia (duration directly related to the dose); convulsions reported in premature infants and neonates
  • Paradoxical reactions — restlessness, agitation, irritability, nervousness, hostility, anger, aggressiveness, anxiety, nightmares, hallucinations, inappropriate behaviour (reported particularly in children and the elderly); confusional state, disorientation
  • Physical dependence and withdrawal syndrome after prolonged IV administration; hypersensitivity, angioedema, anaphylactic shock; nausea, vomiting; injection site erythema and pain; falls and fractures

Interactions

  • NOTE: eMC §4.5 was not captured in this bundle — the interactions below are from the US labelling and must be checked against the UK SPC §4.5 before publication
  • Opioids — concomitant use with benzodiazepines increases the risk of respiratory depression; limit the dose and duration of concomitant use and monitor closely
  • Other CNS depressants — the sedative effect of IV midazolam is accentuated by narcotics (e.g. morphine, pethidine/meperidine, fentanyl), secobarbital and droperidol; adjust the midazolam dose accordingly
  • CYP3A4 inhibitors — caution when given with cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole

Clinical monograph

How it works

It potentiates the inhibitory neurotransmitter GABA at the GABA-A receptor, producing sedation, anxiolysis, anterograde amnesia and muscle relaxation.

Prescribing in practice

  • Titrate slowly to effect with full resuscitation facilities and continuous monitoring, because midazolam causes dose-dependent respiratory depression and hypotension — risk is markedly increased by concomitant opioids and in the elderly, who need substantially reduced doses.
  • Have the reversal agent flumazenil immediately available, and reduce dose in hepatic impairment, debilitated patients and where other CNS depressants are used.
  • Allow adequate time for each increment to take effect before redosing, as delayed onset can lead to inadvertent oversedation.

Monitoring

Monitor respiratory rate, oxygen saturation, blood pressure and conscious/sedation level continuously throughout and during recovery.

Counselling the patient

  • Explain it is a sedative given by injection to relax you, and that you may not remember parts of the procedure.
  • Do not drive, operate machinery, drink alcohol or make important decisions for the rest of the day after sedation, and arrange for someone to accompany you home.

Evidence & guidelines

Midazolam is a standard agent for procedural sedation and anaesthetic premedication; UK safe-sedation guidance and the SPC stress titration, monitoring, dose reduction in the elderly and flumazenil availability.

Reference: MHRA Drug Safety Update 2016 (opioid + benzo); RCoA Regional Anaesthesia Guidelines; NICE NG180 (Sedation in Adults); MHRA SPC Hypnovel; 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.