Benzodiazepine Hypnotic Pregnancy: Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons. Nitrazepam crosses the placental barrier; there have been isolated reports of very large doses causing congenital abnormalities in humans and animal studies have shown reproductive toxicity. Administration in the last trimester or during labour can cause foetal heart rate irregularities, hypothermia, hypotonia, poor sucking and moderate respiratory depression in the neonate. Benzodiazepines are found in breast milk and should not be given to breast-feeding mothers.

Nitrazepam

Brand names: Mogadon

Nitrazepam is a long-acting benzodiazepine hypnotic; this page concerns its use in older people, in whom it is generally best avoided for 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: Elderly and patients with impaired liver and/or renal function: 2.5 mg (5 ml) before retiring to bed, increased if necessary to 5 mg (10 ml). Adults: 5 mg (10 ml) before retiring to bed, increased if necessary to 10 mg (20 ml)

Route: Oral (2.5 mg/5 ml oral suspension; a 20 ml measuring cup graduated from 2.5 ml to 20 ml is included)

Frequency: Once at night, just before going to bed

Max: Adults 10 mg; elderly and patients with impaired liver and/or renal function 5 mg. If organic brain changes are present the dosage should not exceed 5 mg

Nitrazepam is a long-acting benzodiazepine. Dosage should be adjusted on an individual basis and treatment should, if possible, be on an intermittent basis. Treatment should be as short as possible, started with the lowest recommended dose that can control the symptoms, and should not exceed 4 weeks for insomnia including any dose-tapering period; the maximum dose should not be exceeded. Prior to starting, hold a discussion with the patient to put in place a strategy for ending treatment, to minimise the risk of dependence, addiction and drug withdrawal syndrome, and make the patient aware of the possibility of rebound phenomena. Therapy should not be stopped abruptly — the dose should be tapered off; patients who have taken benzodiazepines for a prolonged time may require a longer reduction period and specialist help may be appropriate. For long-acting benzodiazepines, the patient should be checked regularly at the start of treatment so the dose or frequency can be decreased if necessary to prevent overdose due to accumulation. In patients with chronic pulmonary insufficiency and in patients with chronic renal or hepatic disease the dosage may need to be reduced. The elderly are particularly sensitive to the effects of centrally-depressant drugs and undesirable effects may persist into the following day due to the long half-life; due to the myorelaxant effect there is a risk of falls and consequently fractures in the elderly. Contraindicated for use in children. Note: eMC §4.5 (interactions) was not captured in this source bundle.

Dose adjustments

Renal

Patients with impaired renal function are dosed as for the elderly: 2.5 mg (5 ml) before retiring to bed, increased if necessary to 5 mg (10 ml). In patients with chronic renal or hepatic disease the dosage may need to be reduced.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to benzodiazepines, nitrazepam or to any of the excipients
Acute pulmonary insufficiency
Respiratory depression
Phobic or obsessional states
Chronic psychosis
Myasthenia gravis
Sleep apnoea syndrome
Severe hepatic insufficiency
Acute porphyria
Children

Side effects

Drowsiness and reduced alertness (common)
Dizziness and headache (common)
Confusional state, numbed emotions and depression (common; pre-existing depression may be unmasked)
Muscle weakness (common) — with a consequent risk of falls and fractures in the elderly
Fatigue and ataxia (common); diplopia (common); drug dependence and drug withdrawal symptoms

Clinical monograph

How it works

It enhances the inhibitory action of GABA at the GABA-A receptor, increasing chloride conductance to produce sedation, hypnosis and muscle relaxation.

Prescribing in practice

In older people the long half-life causes accumulation, daytime sedation, confusion and a markedly increased risk of falls and fractures, so it is on potentially-inappropriate-medicine lists and should be avoided or used only short term.
Tolerance and dependence develop with continued use; prescribe for the shortest possible period and plan withdrawal early.
Effects are potentiated by alcohol, opioids and other CNS depressants, and there is additive respiratory depression risk.

Monitoring

Review the ongoing need at each contact and monitor for daytime drowsiness, cognitive impairment, falls and signs of dependence.

Counselling the patient

Do not drink alcohol and be aware that drowsiness may persist into the next day, affecting driving.
Do not stop abruptly after regular use; the dose should be reduced gradually under supervision.

Evidence & guidelines

Guidance such as the MHRA and NICE highlights the fall, dependence and cognitive risks of long-acting benzodiazepines in older adults and recommends avoiding routine hypnotic use.

Reference: AGS Beers Criteria 2023; STOPP/START v3; NICE CG49 (Insomnia); 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Temazepam · Benzodiazepine Hypnotic

Pathways