Nitrazepam is indicated in sleep disturbances of various causes, insomnia in neurotic patients, involutional restlessness, sleep disturbances in cerebrosclerotic patients, and myoclonic seizures.

Nitrazepam is a benzodiazepine derivative closely related to diazepam. Unlike barbiturate derivatives, Nitrazepam promotes natural physiological sleep by increasing the stimulus threshold of the hippocampus and does not suppress cortical function. After sleep induced by Nitrazepam, patients typically wake up feeling fully relaxed.

Treatment of insomnia is usually initiated with a dose of 5 mg at night although 2.5 mg is appropriate in elderly patient. The dose may be increased to 10 mg at night if insomnia is severe.

Myoclonic seizures: Children: (up to 30 kg of body weight) between 0.3 and 1.0 mg/kg/day given in 3 divided doses. Treatment should be initiated with lower dose than the usual recommended dosage range in order to determine tolerance and response.

Dosage should be individualized for maximal beneficial effect.

The CNS depressant effects of Nitrazepam may be enhanced when used with alcohol, barbiturates, tricyclic antidepressants (TCAs), phenothiazines, and morphine derivatives. Its effects may be reduced by theophylline. Probenecid may increase its levels and effects, while rifampicin may reduce its levels and efficacy. Nitrazepam may also decrease the effect of levodopa.

Nitrazepam is not recommended during the first trimester of pregnancy. It is contraindicated in patients with myasthenia gravis.

No significant additional symptoms are usually observed even after prolonged treatment.

Dispense only on prescription of a registered physician. Use strictly as directed by the physician. Keep out of reach of children. Store in a cool and dry place.

Symptoms may include somnolence, drowsiness, confusion, ataxia, reduced reflexes, coma, dyspnoea, hypotension, and respiratory and cardiovascular depression.

Management is supportive. Gastric lavage may be useful if done shortly after ingestion. Flumazenil can reverse benzodiazepine-induced CNS depression.

Benzodiazepine hypnotics

Store at room temperature. Protect from light and moisture.