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Long-acting benzodiazepine hypnotic Pregnancy: Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons - there is no evidence of drug safety in human pregnancy nor animal evidence that it is free from hazard. Administration in the last trimester or during labour has been reported to produce foetal heart-rate irregularities and neonatal hypotonia, poor sucking, hypothermia and moderate respiratory depression; infants of mothers who took benzodiazepines chronically in later pregnancy may develop physical dependence and postnatal withdrawal. Use in mothers who are breast-feeding is not recommended (SPC 4.6).

Flurazepam

Brand names: Dalmane

Flurazepam is a long-acting benzodiazepine hypnotic used for the short-term management of insomnia.

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: 15 mg or 30 mg (15 mg is optimal for most patients)
Route: Oral
Frequency: Once at night, just before going to bed
Max: Patients with severe insomnia may require 30 mg, but no more than 60 mg
Source product is Dalmane 15 mg Capsules; indication is insomnia. Dose should be determined on an individual basis taking into account the severity of the insomnia and the patient's response; dosage determines the duration of effect and the occurrence of residual effects. 15 mg ensures a full night's sleep with minimal residual effects on wakening; residual effects on awakening, associated with an anxiolytic effect, are more frequent at 30 mg. Elderly or debilitated patients: the initial dose should not exceed 15 mg, and if organic brain changes are present the dose should not exceed 15 mg. Chronic pulmonary insufficiency: the dosage may need to be reduced. Treatment should, if possible, be on an intermittent basis, started at the lowest recommended dose, and the maximum dose should not be exceeded; duration generally varies from a few days to two weeks with a maximum of four weeks including the tapering-off process. Long-term chronic use is not recommended. Flurazepam is a long-acting benzodiazepine, so check the patient regularly and reduce the dose or frequency if necessary to prevent overdose due to accumulation; patients who have taken benzodiazepines for a prolonged time may require a longer reduction period. Paediatric: Dalmane is contraindicated for use in children. Capsules should be taken just before going to bed and swallowed with water without chewing. The US label in the same bundle recommends an initial dose of 15 mg for women and either 15 mg or 30 mg for men (15 mg may be increased to 30 mg if needed for efficacy), with 15 mg in elderly or debilitated patients - verify against the UK SPC before use. eMC section 4.5 was not captured in this bundle (section 4.4 truncated at the source-fetch limit), so the interactions listed come from eMC section 4.4 and the US label.

Dose adjustments

Renal

Patients with hepatic and renal impairment: the initial dose is 15 mg and in general should not be exceeded (SPC 4.2); reduced doses should be given to patients with renal or hepatic disease (SPC 4.4).

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

  • Known hypersensitivity to flurazepam, other benzodiazepines or any of the excipients
  • Myasthenia gravis
  • Severe pulmonary insufficiency
  • Respiratory depression
  • Sleep apnoea syndrome
  • Severe hepatic insufficiency
  • Phobic or obsessional states
  • Chronic psychosis
  • Spinal and cerebellar ataxia
  • Use in children

Side effects

  • Daytime somnolence, reduced alertness and fatigue; emotional poverty
  • Dizziness, headache, ataxia, dysgeusia (common); anterograde amnesia and extrapyramidal disorder (frequency not known)
  • Muscle weakness (common), with a risk of falls and consequent fractures in the elderly
  • Confusional state, hallucinations, depression, dependence, withdrawal syndrome, rebound effect and paradoxical drug reactions (frequency not known)
  • Visual impairment such as diplopia, vertigo, hypotension, urinary retention (rare)
  • Respiratory depression, particularly at night (rare)
  • Jaundice and hepatic enzyme increase (very rare); blood disorders including agranulocytosis (frequency not known)

Interactions

  • Opioids - concomitant use may result in sedation, respiratory depression, coma and death; reserve for patients with no alternative, use the lowest effective dose for the shortest duration and monitor closely (eMC 4.4; US label 7.1)
  • Other CNS depressants including ethanol, psychotropic medications, anticonvulsants and antihistamines - additive CNS depressant effects; downward dose adjustment of flurazepam and/or the concomitant depressant may be necessary (US label 7.2)
  • Acute intoxication with alcohol, sedative agents, hypnotic agents, analgesics or psychotropic agents (neuroleptics, antidepressants, lithium) - Dalmane should not be given (eMC 4.4)
  • History of alcohol or drug abuse - benzodiazepines should be used with extreme caution (eMC 4.4)

Clinical monograph

How it works

It potentiates GABA at the GABA-A receptor to enhance inhibitory neurotransmission, producing sedative and hypnotic effects.

Prescribing in practice

  • Its long half-life and active metabolites cause accumulation and pronounced next-day sedation, so use should be short-term and cautious, particularly in the elderly.
  • Dependence, tolerance and withdrawal limit duration of use; avoid abrupt cessation.
  • Combination with alcohol or other CNS depressants increases sedation and respiratory depression.

Monitoring

Monitor for next-day sedation, accumulation, dependence and respiratory depression, especially in older patients.

Counselling the patient

  • May cause significant drowsiness the next day, affecting driving and skilled tasks.
  • Avoid alcohol and other sedating medicines.
  • Use for the shortest period possible and do not stop suddenly after regular use.

Evidence & guidelines

Benzodiazepine hypnotics are recommended only for short-term insomnia because of dependence and residual sedation, consistent with NICE guidance.

Reference: NICE TA77; 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.