Indications

Nitrazepam is indicated in disturbances of sleep of various aetiology, insomnia of the neurotics, involutional restlessness, disturbances of sleep of cerebrosclerotic patients, Myoclonic seizures etc.

Composition

Pharmacology

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.

Dosage & Administration

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.

Contraindications

It is not recommended to use Nitrazepam during the first three months of the pregnancy. In myasthenia gravis, administration of Nitrazepam is contra-indicated.

Side Effects

Patients do not show additional symptoms even after a prolonged treatment.

Pregnancy & Lactation

Precautions & Warnings

To be dispensed only by or on the prescription of a registered physician. To be taken as directed by physician. Keep out of reach of children. Keep in a cool & dry place.

Therapeutic Class

Benzodiazepine hypnotics

Storage Conditions

Store at room temperature. Protect from light and moisture.