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Benzodiazepine Hypnotic — Schedule 3 Controlled Drug Pregnancy: Section 4.6: 'Insufficient data are available on temazepam to assess its safety during pregnancy and lactation. If the product is prescribed to a woman of child bearing age, she should be warned to contact her physician about stopping the product if she intends to become, or suspects that she is, pregnant. If for compelling medical reasons, temazepam is administered during the late phase of pregnancy, or during labour, effects on the neonate, such as hypothermia, hypotonia, and moderate respiratory depression, can be expected due to the pharmacological action of the product. Moreover, infants born to mothers who took benzodiazepines chronically during the later stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.' Breast-feeding is a listed CONTRAINDICATION (section 4.3): 'Since benzodiazepines are found in breast milk, temazepam should not be administered to breast feeding mothers.'

Temazepam

Brand names: Generic only (Temazepam) — no branded preparation

Temazepam is a short-acting benzodiazepine hypnotic used for the short-term treatment of insomnia that is severe, disabling or causing marked distress.

Adult dose

Dose: Insomnia: 10-30 mg orally on retiring; 20 mg is satisfactory for most patients. May be increased to 30-40 mg in patients who do not respond to the lower dose.
Route: Oral only ('For oral administration only'). Source product is a 10 mg per 5 ml oral solution, so 10-30 mg equates to 5-15 ml and 30-40 mg to 15-20 ml OF THAT SOLUTION - do not transfer those volumes to any other strength.
Frequency: Once nightly, on retiring. 'Treatment should if possible be intermittent.' Duration should not exceed 4 weeks for insomnia, including the tapering-off process.
Verbatim section 4.2, Insomnia, Adults: 'The usual dose is 5 - 15ml (10-30mg) orally on retiring; a dose of 10ml (20mg) will be found to be satisfactory for most patients. This may be increased to 15 - 20ml (30 - 40mg) in patients who do not respond to the lower dose. Lower doses may be adequate for some patients, as for the elderly.' DURATION AND TAPERING (verbatim): 'Treatment should if possible be intermittent. The lowest dose which can control symptoms should be used. It should not be continued beyond 4 weeks. Long term chronic use is not recommended. Treatment should always be tapered off gradually. Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced.' Section 4.4 adds that the duration 'should not exceed 4 weeks for insomnia, including tapering off process'. ELDERLY (verbatim): 'Elderly patients or those suffering from cerebral vascular changes such as arteriosclerosis are likely to respond to smaller doses. Half the normal dose, 2.5 - 7.5ml (5 - 15mg) may be sufficient for a therapeutic response.' Section 4.4: 'Doses of 30mg and above are more likely to cause hangover effects to persist into the following day than lower doses, particularly in patients unused to hypnotics and in the elderly.' SECOND INDICATION IN THE SAME LICENCE, NOT THE DOSE ABOVE: the SPC also gives a pre-medication regimen before surgery or investigative procedures (verbatim: 'Pre-medication 10 - 20ml (20 - 40mg) from half an hour to one hour prior to surgery or investigative procedures'), with section 4.4 requiring that 'the patients should be accompanied home'. That is not an insomnia dose. maxDose IS DELIBERATELY EMPTY: section 4.2 states no maximum dose for insomnia. The 40 mg figure is the top of an escalation range, not a stated ceiling, and the only explicit limit in the SPC is a DURATION limit (4 weeks), not a dose ceiling - so nothing here may be used to cap a calculated dose. US CROSS-CHECK (openFDA/DailyMed, US labelling, NOT used for the figures above and lower than them): 'the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.' The US label also directs a gradual taper to discontinue or reduce the dosage, pausing the taper or returning to the previous level if withdrawal reactions develop.

Paediatric dose

Route: Oral - but insomnia in the paediatric population is 'Not recommended' in this SPC (see notes)
NO PAEDIATRIC DOSE IS PUBLISHED FOR THIS PAGE'S INDICATION. Verbatim section 4.2: 'Paediatric population : Insomnia Not recommended'. dosePerKg is null deliberately so that no weight-based calculator can run on this page. The SPC does contain one paediatric per-kilogram figure, but it belongs to a DIFFERENT indication - pre-medication before surgery or investigative procedures - and it is deliberately not reproduced here so it cannot be misapplied to insomnia; read it from the SPC itself if a pre-medication dose is genuinely required. Section 4.8 notes that behavioural adverse effects (delusions, hallucinations, irritability, agitation, aggressiveness, nightmares, rages) 'are more likely to occur in children and in the elderly'. Verify any under-18 use against a children's formulary.

Dose adjustments

Renal

No renal dose adjustment is stated anywhere in the fetched sections - section 4.2 contains no renal-impairment posology. Section 4.4 states only: 'Temazepam should be given with caution to patients with chronic pulmonary insufficiency, or those with renal or hepatic dysfunction.' Note that section 4.4 is truncated at the source-fetch limit, so a renal instruction beyond the fetched text cannot be excluded.

Hepatic

Severe hepatic insufficiency is a CONTRAINDICATION (section 4.3): 'Severe hepatic insufficiency (may precipitate encephalopathy. Elimination half-life of temazepam may be prolonged).' Section 4.4 adds: 'Temazepam should be given with caution to patients with ... renal or hepatic dysfunction. Sedatives given to patients with cirrhosis may precipitate encephalopathy.' No numeric dose adjustment for lesser degrees of hepatic impairment is given in the fetched sections.

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, to benzodiazepines or to any of the excipients listed in section 6.1
  • Neuromuscular respiratory weakness including myasthenia gravis (condition may be exacerbated)
  • Acute pulmonary insufficiency, severe respiratory depression, sleep apnoea syndrome (risk of further respiratory depression) or CNS depression
  • Severe hepatic insufficiency (may precipitate encephalopathy; elimination half-life of temazepam may be prolonged)
  • Phobic or obsessional state; chronic psychosis (paradoxical reactions may occur; inadequate evidence of safety and efficacy)
  • Mild anxiety states
  • Acute narrow angle glaucoma (due to anticholinergic effects of temazepam)
  • As monotherapy in patients with depression or those with anxiety and depression (suicide may be precipitated in these patients)
  • Breast-feeding

Side effects

  • At the start of treatment: drowsiness and light-headedness the next day; confusion and ataxia (especially in the elderly); amnesia; dependence
  • Reduced alertness, dizziness, muscle weakness, fatigue, numbed emotions, double vision, unsteadiness, respiratory depression, slurred speech - these will normally disappear with continued treatment
  • More rarely: headache, vertigo, hypotension, salivation changes, visual disturbances, dysarthria, tremor, incontinence, urinary retention, blood disorders, jaundice, vivid dreams/nightmares, restless sleep, palpitations, change in libido, skin reactions, sedation, impaired muscular function, dry mouth and gastro-intestinal disturbances
  • Severe anaphylactic and anaphylactoid reactions, including rare cases of fatal anaphylaxis; angioedema involving the tongue, glottis or larynx has been reported after the first or subsequent doses (section 4.4)
  • Pre-existing depression may be unmasked during treatment; blood dyscrasias and increased liver enzymes reported occasionally - discontinue if these occur
  • Delusions, psychoses, hallucinations, irritability, restlessness, agitation, aggressiveness, nightmares, rages and other inappropriate behaviour - more likely to occur in children and in the elderly; discontinue if they occur
  • Dependence: use even at therapeutic doses may lead to physical dependence; psychological dependence may occur and abuse of benzodiazepines has been reported
  • Withdrawal on abrupt cessation: depression, anxiety, headache, dizziness, impaired concentration, tinnitus, loss of appetite, tremor, perceptual disturbances, nausea, vomiting, abdominal cramps, palpitations, mild systolic hypertension, tachycardia, orthostatic hypotension, photophobia, hyperacusis, confusion, tension, nervousness, rebound insomnia, irritability, sweating and diarrhoea; rarely confusional states, psychotic manifestations and convulsions

Monitoring

  • Duration of treatment - it 'should not exceed 4 weeks for insomnia, including tapering off process' (section 4.4), and extension beyond this should not take place without re-evaluation of the situation
  • Dependence risk: 'Regular monitoring of treatment in such patients is essential' in patients with a history of alcoholism, drug abuse or marked personality disorders (section 4.4; this passage is truncated at the source-fetch limit)
  • Withdrawal and rebound phenomena - with a short-acting benzodiazepine such as temazepam, withdrawal phenomena can become manifest between doses, especially when the dosage is high
  • Next-day hangover effects, particularly in patients unused to hypnotics and in the elderly, at doses of 30 mg and above
  • Response and tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardiorespiratory insufficiency - 'care must be taken in adapting the dosage with such patients'
  • Signs of respiratory or hepatic decompensation - caution in chronic pulmonary insufficiency and in renal or hepatic dysfunction; sedatives given to patients with cirrhosis may precipitate encephalopathy

Clinical monograph

How it works

It enhances the inhibitory action of GABA at the GABA-A receptor, increasing chloride conductance to produce sedative, hypnotic and anxiolytic effects.

Prescribing in practice

  • Use for the shortest possible time because tolerance and dependence develop, and it is a controlled drug subject to misuse.
  • Combining with opioids or other CNS depressants markedly increases the risk of sedation, respiratory depression and death.
  • Use cautiously in the elderly because of the risk of falls, confusion and daytime sedation, and avoid in significant respiratory impairment.

Monitoring

No routine laboratory monitoring is required; review ongoing need, effectiveness and signs of tolerance or dependence at short intervals.

Counselling the patient

  • Take just before bedtime and only for a short course as agreed.
  • Avoid alcohol and do not drive if you feel drowsy, as effects can persist into the next day.
  • Do not stop abruptly after regular use; the dose should be reduced gradually to avoid withdrawal.

Evidence & guidelines

NICE guidance restricts hypnotic benzodiazepines such as temazepam to short-term use for severe insomnia at the lowest effective dose.

Reference: NICE NG215 (Insomnia); NICE CG22 (Anxiety); 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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