Nitrazepam

What it is and how it works

Nitrazepam enhances GABA-mediated inhibition by binding to the benzodiazepine site of the GABA-A receptor, producing sedative, hypnotic, anxiolytic and anticonvulsant effects; its long half-life may cause next-day residual effects.

Indications

Short-term treatment of severe or disabling insomnia where daytime sedation is acceptable; occasionally used in some infantile epilepsies (specialist use).

Dosage and administration (summary)

Oral at bedtime: adults usually 5–10 mg; elderly or debilitated patients 2.5–5 mg; treatment should be limited to the shortest possible duration.

Contraindications

Respiratory depression, severe respiratory insufficiency, sleep apnoea syndrome, myasthenia gravis, severe hepatic impairment and acute pulmonary insufficiency.

Warnings and precautions

Risk of dependence and withdrawal symptoms; avoid abrupt discontinuation after prolonged use. Hangover sedation impairs driving and increases the risk of falls in the elderly. Profound sedation and respiratory depression may occur with opioids, alcohol or other CNS depressants.

Pregnancy

Avoid regular use, especially late in pregnancy, because of neonatal sedation, hypotonia and withdrawal.

Storage and supply

Store below 25 °C, protected from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.