short-term relief from severe, disabling anxiety and insomnia.
Nitrazepam is a benzodiazepine derivative nearly related to diazepam. Contrary to barbiturate derivatives Nitrazepam gives free way to physiologic sleep by increasing the stimulus threshold of hypocampus and does not inhibit cortical function. After a sleep with Nitrazepam patients awaken thoroughly relaxed.
ORAL Short-term management of insomnia: Adult: 5 mg at night; increase to 10 mg if necessary. Elderly: & debilitated patients: normal adult dose. Infantile spasms: Child: Infants: 125 mcg/ kg bid; gradually increase to 250-500 mcg/ kg bid.
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.
Myasthenia gravis, narrow-angle glaucoma, severe resp insufficiency, sleep apnoea syndrome, severe hepatic impafrment porphyria. 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, esp if suicidal risk may be present. History of drug abuse or acute alcoholism. Hepatic & renal impairment. Respiratory disease. Debilitated patients. Patients who are at risk of falls. Children, elderly. Pregnancy & lactation.
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 w/ withdrawal); aspiration, increased bronchial secretion, dyspnoea.
nitrazepam should be avoided during pregnancy. In early pregnancy, nitrazepam levels are lower in the baby than in the mother, and in the later stages of pregnancy, nitrazepam is found in equal levels in both the mother and the unborn child. Nitrazepam is not approved for marketing in the United States by the US Food and Drug Administration. It is excreted into breastmilk in small amounts. Because of its long half-life of about 30 hours, it may accumulate in the serum of breastfed infants with repeated doses.
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.
Store at room temperature. Protect from light and moisture.
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