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Nitrazepam is a hypnotic drug of the benzodiazepine class used for short-term relief from severe, disabling anxiety and insomnia. It also has sedative properties, as well as amnestic, anticonvulsant, and skeletal muscle relaxant effects.

Therapeutic Class

Benzodiazepine hypnotics

Pharmacology

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.

Dosage

Short-term management of insomnia:

• Adult: 5 mg at night; increase to 10 mg if necessary.

• Elderly: and debilitated patients: ≤normal adult dose.

Infantile spasms:

• Child: Infants: 125 mcg/kg bid; gradually increase to 250-500 mcg/kg bid.

Administration

May be taken with or without food

Interaction

Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally acting drugs such as neuroleptics, tranquillizers, antidepressants, hypnotics, analgesics and an aesthetics, anti-epileptics and sedative antihistamines.

In the case of narcotic analgesics, enhancement of the euphoria may also occur, leading to an increase in psychological dependence. The elderly requires special supervision.

The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Mogadon with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.

The dosage and duration of concomitant use should be limited (see section 4.4).

When Mogadon is used in conjunction with anti-epileptic drugs, side-effects and toxicity may be more evident, particularly with hydantoins or barbiturates or combinations including them. This requires extra care in adjusting dosage in the initial stages of treatment.

Known inhibitors of hepatic enzymes, particularly cytochromes P450 have been shown to reduce the clearance of benzodiazepines and may potentiate their action and known inducers of hepatic enzymes, e.g. rifampicin, may increase the clearance of benzodiazepines.

Concomitant intake with alcohol should be avoided. The sedative effect may be enhanced when the product is used in combination with alcohol. This adversely affects the ability to drive or use machines.

Contraindications

Patients with hypersensitivity to benzodiazepines, nitrazepam or to any of the excipients listed in section 6.1

Hypersensitivity reactions with the benzodiazepines including rash, angioedema and hypertension have been reported on rare occasions in susceptible patients.

Use of this drug is also contraindicated in patients with acute pulmonary insufficiency; respiratory depression; phobic or obsessional states; chronic psychosis; myasthenia gravis; sleep apnoea syndrome; severe hepatic insufficiency; use in children.

Side Effects

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.

Pregnancy & Lactation

Category not classified

Precautions & Warnings

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.

Overdose Effects

Symptoms: Somnolence, drowsiness, confusion, ataxia, impaired reflexes, coma, dyspnea, hypotension, respiratory and cardiovascular depression.

Management: Supportive. Gastric lavage may be beneficial if performed soon after ingestion. Flumazenil may reverse benzodiazepine-induced CNS depression.

When taken alone in overdosage Mogadon presents few problems in management and should not present a threat to life unless combined with other CNS depressants (including alcohol).

In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.

Symptoms:

Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, dysarthria and lethargy;

in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.

Storage Conditions

Store at room temperature. Protect from light and moisture.