Nitrazepam

Indications
 Oral
Short-term management of insomnia
Adult: 5 mg at night; increase to 10 mg if necessary.
Elderly: and debilitated patients: ≤normal adult dose.
Oral
Infantile spasms
Child: Infants: 125 mcg/kg bid; gradually increase to 250-500 mcg/kg bid.
Contraindications
 Myasthenia gravis, narrow-angle glaucoma, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic impairment, porphyria.
Warnings / Precautions
 May induce anterograde amnesia; caution patients to have uninterrupted sleep of 7-8 hr after ingestion of dose. May impair ability to drive or operate machinery. Depression, especially if suicidal risk may be present. History of drug abuse or acute alcoholism. Hepatic and renal impairment. Respiratory disease. Debilitated patients. Patients who are at risk of falls. Children, elderly. Pregnancy and lactation.
Adverse Reactions
 Hypotension, palpitation; agitation, aggressiveness, amnesia, ataxia, confusion, delusions, disorientation, dizziness, fatigue, hallucination, hangover, headache, irritability, nightmares, psychoses, rage, restlessness, sedation; rash; changes in libido; constipation, diarrhoea, excessive salivation, heartburn, nausea, vomiting; granulocytopenia, leukopenia; falling, muscle weakness; blurred or double vision; tinnitus (associated with withdrawal); aspiration, increased bronchial secretion, dyspnoea.
Overdose Reactions
 Symptoms: Somnolence, drowsiness, confusion, ataxia, impaired reflexes, coma, dyspnoea, hypotension, respiratory and cardiovascular depression. Management: Supportive. Gastric lavage may be beneficial if performed soon after ingestion. Flumazenil may reverse benzodiazepine-induced CNS depression.
Drug Interactions
 CNS depressant effect increased with alcohol, barbiturates, TCAs, phenothiazines, morphine derivatives. Effects may be antagonised by theophylline. Increased levels/effects with probenecid. Reduced levels/effects with rifampicin. May reduce effects of levodopa.
See Below for More nitrazepam Drug Interactions
Lab Interactions
 May cause false elevations (about 15%) in clozapine plasma levels.
Food Interactions
 Increased CNS depression may occur with valerian, kava kava, St John's wort, gotu kola.
Mechanism of Actions
 Nitrazepam is a benzodiazepine with a pronounced sleep-inducing activity. It depresses the reticular-activating system in the brainstem by enhancing the inhibitory effect of GABA on brain cells, thus preventing excessive brain activity.
Onset: 30-60 min.
Duration: 6-8 hr.
Absorption: Fairly absorbed from the GI tract (oral). Peak plasma levels in 2-3 hr.
Distribution: Crosses the blood-brain barrier and placenta; enters breast milk (trace amounts). Protein-binding: 87%.
Metabolism: Hepatic by nitroreduction followed by acetylation.
Excretion: Urine (as free or conjugated metabolites); 24-30 hr (elimination half-life).
Administration
 May be taken with or without food.
Storage Conditions
 Oral: Store at room temperature. Protect from light and moisture.
ATC Classification
 N05CD02 - nitrazepam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.
Storage
 Oral: Store at room temperature. Protect from light and moisture.
Available As
  • Nitrazepam 10 mg
  • Nitrazepam 2.5 mg
  • Nitrazepam 20 mg
  • Nitrazepam 5 mg

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