Description
Nitrazepam
Nitrazepam is a benzodiazepine medicine used as a hypnotic and sedative. It is verified as a long-acting benzodiazepine with anxiolytic, sedative and hypnotic properties.
Active Ingredient and Medicine Class
The active ingredient is nitrazepam. It belongs to the benzodiazepine derivatives group, ATC code N05CD02, and acts on the central nervous system.
Established Medical Uses
Official product information identifies short-term treatment of insomnia, particularly when it is severe, disabling, or causes unacceptable distress. The medicines.org.uk SmPC also notes that an underlying cause for insomnia should be sought before use.
How It Works
Nitrazepam enhances the effect of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the brain, which helps reduce nervous system activity and promote sleep. Product information describes it as having sedative and hypnotic effects.
Important Safety Information
Nitrazepam is contraindicated in hypersensitivity to benzodiazepines or nitrazepam, acute pulmonary insufficiency, respiratory depression, sleep apnoea syndrome, myasthenia gravis, severe hepatic insufficiency, acute porphyria, chronic psychosis, phobic or obsessional states, and in children.
Important precautions include the risk of tolerance, dependence, addiction, withdrawal symptoms, amnesia, paradoxical behavioural reactions, and worsening sedation in older adults or people with respiratory or hepatic impairment. The SmPC warns that alcohol and other CNS depressants can increase sedative effects, and that opioids may increase the risk of profound sedation, respiratory depression, coma, and death.
Possible Side Effects
Reported adverse effects include drowsiness, impaired psychomotor and cognitive performance, dizziness, amnesia, confusion, and morning hangover. More serious reactions can include respiratory depression, paradoxical agitation, hallucinations, behavioural changes, dependence, and withdrawal symptoms after stopping.
Scientific Evidence
Published clinical studies and reviews show that nitrazepam can improve sleep onset and sleep quality in insomnia, but evidence for long-term use is limited and older studies suggest the risk of residual sedation and withdrawal effects. A recent network meta-analysis found nitrazepam was associated with somnolence versus placebo, although the evidence base for some outcomes was limited and uncertain.
Medical Information Notice
This page is an educational summary based on sources available at the time of review and does not replace the official patient leaflet or individual assessment by a qualified healthcare professional.
Medical Sources
- Medicines and Healthcare products Regulatory Agency / emc — Mogadon 5 mg Tablets: Summary of Product Characteristics
- Medicines and Healthcare products Regulatory Agency / emc — Nitrazepam Mixture 2.5mg/5ml Oral Suspension BP: Summary of Product Characteristics
- Lee et al. — “Adverse events of pharmacological interventions for insomnia disorder in adults: a systematic review and network meta-analysis” — Sleep Medicine (2024) — PubMed
