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Benzodiazepine / Antiepileptic Pregnancy: There is no evidence regarding the safety of diazepam in pregnancy. It should not be used, especially in the first and third trimesters, unless the benefit is considered to outweigh the risk. The risk of congenital abnormalities from therapeutic doses of benzodiazepines appears slight, although a few epidemiological studies have pointed to an increased risk of cleft palate. If administered during the late phase of pregnancy or during labour at high doses or repeated low doses, hypothermia, hypotonia and respiratory depression, irregularities in the foetal heart and poor suckling (floppy infant syndrome) in the neonate can be expected; infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and be at risk of withdrawal symptoms in the postnatal period. Women of childbearing potential should be advised to contact their physician regarding discontinuation if they intend to become or suspect that they are pregnant. Breast-feeding: diazepam is excreted in the breast milk and use during lactation should be avoided; it is metabolised significantly more slowly in the neonate, so if diazepam therapy is essential, breast-feeding should be terminated. Fertility: no clinical data on fertility are available.

Diazepam (Rectal)

Brand names: Stesolid, Rectioles

Used in: Seizures & Epilepsy

This page covers rectal diazepam (rectal solution), a benzodiazepine used for the emergency treatment of prolonged or serial seizures and as community rescue medication, including in children.

Adult dose

Dose: Epileptic and febrile convulsions, adults: two 10 mg tubes of Diazepam Desitin 10 mg Rectal solution given rectally
Route: Rectal
Frequency: If no effect is seen after 10 minutes an additional 10 mg tube can be given to adults; the dose can be repeated every 12 hours
The pinned product, Diazepam Desitin 10 mg Rectal solution (eMC product 3001), is licensed in section 4.1 for 'Epileptic and febrile convulsions' (also muscle spasm in tetanus, sedation in minor surgical and dental procedures, and initial use in severe anxiety/agitation), 'when a rapid effect is required but where intravenous injection is impracticable or undesirable', and 'may be of particular value for the immediate treatment of convulsions in children'. The indication and rectal route match. ROUTE THIS CARD DOES NOT COVER: intravenous - this SPC is for rectal use only ('For rectal administration only'), so no IV dose is given. The SPC states: 'The usual dose is 0.25 - 0.5 mg / kg. Dosage depends on age, weight and individual response.' Because the product comes in fixed unit-doses of 5 and 10 mg, 'the dose is obtained by rounding upward to the next available dose'; for 5 mg doses the SPC recommends Diazepam Desitin 5 mg Rectal solution. No daily maximum is printed in the retrieved sections, so maxDose is not stated. Respiration: 'In case of initially higher doses or repeated administration respiration should be monitored.' 'If convulsions are still not controlled other anticonvulsive measures should be instituted.' 'Treatment should be as short as possible. The lowest dose that can control the symptoms should be used.' Elderly and debilitated patients: 'not more than one half the usual adult dose.' Chronic respiratory insufficiency: a lower dose is recommended (risk of respiratory depression). Liver or kidney dysfunction: dosage reduction may be required. Administration: adults in the lateral position; insert the tube nozzle completely into the rectum, empty the tube completely with firm pressure, keep pressure on the tube until withdrawn, and press the buttocks together for a short time; tubes are single use.

Paediatric dose

Dose: Children 10 to 15 kg (1 to 3 years): one 5 mg tube of Diazepam Desitin 5 mg Rectal solution. Children over 15 kg (over 3 years): one 10 mg tube. Under 10 kg (under 1 year): not recommended.
Route: Rectal (children in the prone or lateral position)
Frequency: If no effect is seen after 10 minutes the dose can be repeated in children; the dose can be repeated every 12 hours
Fixed tube doses by weight band exactly as printed in SPC 4.2 - not calculated per kg. For the 10 to 15 kg band, insert the tube only half way to the mark on the nozzle (SPC: for children under 15 kg, insert only half way). The 5 mg tube is a different presentation (Diazepam Desitin 5 mg Rectal solution) from the pinned 10 mg product. In case of repeated administration respiration should be monitored. Diazepam should not be given to children and adolescents without careful assessment of the need, and treatment duration must be kept to a minimum. Individual response should be monitored at the start of therapy to recognise relative overdose due to accumulation, particularly in children. Use a children's formulary for any situation not covered by these bands.

Dose adjustments

Renal

SPC 4.2: 'Dosage reduction may also be required in patients with liver or kidney dysfunction.' SPC 4.4: diazepam should only be used with particular caution in patients with renal or hepatic dysfunction. No numeric adjustment is stated.

Hepatic

Severe hepatic insufficiency is a contraindication (SPC 4.3); diazepam is not indicated in severe hepatic insufficiency as it may precipitate encephalopathy (SPC 4.4). SPC 4.2: 'Dosage reduction may also be required in patients with liver or kidney dysfunction.' No numeric adjustment is stated.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, other benzodiazepines or to any of the excipients
  • Myasthenia gravis
  • Severe respiratory insufficiency
  • Sleep apnoea syndrome
  • Severe hepatic insufficiency

Side effects

  • Common: reduced alertness, numbed emotions, confusion, anterograde amnesia (which can be associated with inappropriate behaviour), paradoxical reactions; heavy sedation, drowsiness, headaches, dizziness (with risk of falls in the elderly), ataxia, dysarthria including slurred speech, tremor; double vision; increased muscle spasm, myasthenia; fatigue
  • Uncommon: impaired concentration
  • Rare: blood dyscrasias including thrombocytopenia; increased appetite; loss of libido, increased libido; blurred vision, nystagmus; bradycardia, heart failure including cardiac arrest; hypotension; laryngeal spasm, respiratory depression including apnoea and respiratory arrest
  • Rare: nausea, vomiting, epigastric pain, obstipation, diarrhoea, dry mouth; cholestatic jaundice, hepato-cellular jaundice; urinary retention, incontinence; menstrual disturbances; chest pain, hang-over effects; elevation of ALT, AST, alkaline phosphatase
  • Very rare: allergic skin reactions, including pruritus, urticaria and angioedema
  • Not known: vertigo; increased salivation; risk of falls
  • Dependence: use (even at therapeutic doses) may lead to physical dependence, with withdrawal or rebound phenomena on discontinuation; psychic dependence may occur; abuse has been reported

Interactions

  • Alcohol: diazepam should not be used concurrently with alcohol (sedative effect may be enhanced)
  • Other CNS depressants: may enhance the CNS depressive effects, possibly leading to profound sedation and clinically relevant cardiovascular and/or respiratory depression
  • Opioids: concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death; reserve concomitant prescribing for patients for whom alternative options are inadequate and limit dosages and durations to the minimum required

Monitoring

  • Monitor respiration after initially higher doses or repeated administration
  • Monitor individual patient response at the start of therapy to recognise relative overdose due to accumulation, particularly in elderly and debilitated patients and in children and adolescents
  • Follow patients for signs and symptoms of respiratory depression and sedation, especially with opioids or other CNS depressants
  • Patients in shock may be treated only if measures are concurrently undertaken to correct the volume deficiency
  • Reassess regularly and evaluate the need for continued treatment; for longer-term use, evaluate after no more than 4 weeks and reduce the dose gradually on discontinuation (withdrawal and rebound phenomena)

Clinical monograph

How it works

It enhances GABA-A receptor-mediated chloride conductance, increasing inhibitory neurotransmission to terminate seizure activity; the rectal route gives rapid absorption when intravenous access is unavailable.

Prescribing in practice

  • The main hazard is respiratory and CNS depression, so administer with attention to airway and breathing and provide carers with a clear rescue protocol including when to call emergency services.
  • Effect is potentiated by alcohol, opioids and other CNS depressants, which compound respiratory depression.
  • Use cautiously in respiratory insufficiency; for children, a children's formulary should be consulted and a written individualised emergency care plan provided to carers.

Monitoring

Monitor conscious level, respiration and seizure response after administration, observing for sedation and the need for further emergency care.

Counselling the patient

  • Carers should be trained on technique, dosing and exactly when to seek emergency help.
  • Watch for excessive drowsiness or slowed breathing after a dose.
  • Record the time and response of each administration.

Evidence & guidelines

Rectal diazepam is an established option for terminating prolonged convulsive seizures when intravenous access is not available, reflected in UK status epilepticus guidance, where buccal midazolam is often now preferred in the community.

Reference: NICE CG137; APLS guidelines; 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.

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