Description
Nitrabit (Nitrazepam) 10 mg
Nitrabit is a branded medicine containing nitrazepam, a benzodiazepine hypnotic. It is used for short-term management of insomnia in settings where this medicine is licensed, but it is not appropriate for all causes of sleep difficulty. Nitrazepam is a central nervous system depressant and can cause sedation, impaired alertness and dependence with continued use.
Active Ingredient and Medicine Class
The verified active ingredient is nitrazepam. It belongs to the benzodiazepine class and acts as a hypnotic, with sedative, anxiolytic, muscle-relaxant and anticonvulsant properties.
Established Medical Uses
Regulatory product information identifies nitrazepam as a treatment for insomnia, particularly short-term insomnia. It is not a cure for the underlying cause of sleep disturbance.
How It Works
Nitrazepam enhances the effect of gamma-aminobutyric acid (GABA), the brain’s main inhibitory neurotransmitter. This reduces central nervous system activity, which helps promote sleep but also explains its sedative and psychomotor effects.
Important Safety Information
Nitrazepam is contraindicated or should be avoided in people with sleep apnoea syndrome, severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, and in children for insomnia treatment. Product information also warns about use in patients with a history of substance misuse, and about the risk of tolerance, dependence and withdrawal symptoms.
Clinically significant interactions include other central nervous system depressants, especially opioids, which can increase the risk of profound sedation, respiratory depression, coma and death. Alcohol and other sedating medicines may also intensify its effects.
Possible Side Effects
Common adverse effects include drowsiness, daytime sedation, dizziness, fatigue, reduced coordination and next-day impairment. Important serious reactions include confusion, falls, paradoxical agitation, memory problems, respiratory depression and dependence. Withdrawal symptoms may occur when treatment is stopped after repeated use.
Scientific Evidence
Peer-reviewed reviews of insomnia pharmacotherapy describe benzodiazepine hypnotics, including nitrazepam, as effective for short-term symptom relief, but limited by tolerance, dependence, cognitive and psychomotor impairment, and fall risk. Comparative evidence has also shown that benzodiazepine hypnotics can improve sleep outcomes, while safety concerns limit long-term use.
Medical Information Notice
This page is an educational summary based on sources available at the time of review. It does not replace the official patient leaflet, regulatory prescribing information or assessment by a qualified healthcare professional.
Medical Sources
- Organon / emc. Mogadon 5 mg Tablets – Summary of Product Characteristics
- Andrew D Krystal et al. Insomnia medications: History, characteristics, and guidelines for optimal use in clinical practice. J Sleep Res. 2023.
