BMA Concise Guide to Medicine & Drugs

Nitrazepam

Brand names Mogadon, Remnos, Somnite

Used in the following combined preparations None

QUICK REFERENCE

Drug group Benzodiazepine sleeping drug

Overdose danger rating Medium

Dependence rating High

Prescription needed Yes

Available as generic Yes

GENERAL INFORMATION

Nitrazepam is a long-acting benzodiazepine used for the short-term treatment of insomnia. Benzodiazepines relieve tension and nervousness, relax muscles, and encourage sleep. When nitrazepam is taken at night, there are often “hangover” effects the next day. Taken every night, its effects steadily accumulate. Therefore, short courses of one or two weeks are usually prescribed. Long-term use of the drug leads to daytime sedation, tolerance, and dependence.

Stopping nitrazepam after prolonged use gives rebound insomnia, anxiety, and a withdrawal syndrome that may include confusion, toxic psychosis, and seizures. In this situation, a tapering off of the dosage over many weeks may be needed.

It is recommended that benzodiazepines should be used to treat insomnia only when the problem is short-term and severe, disabling, or very distressing.

INFORMATION FOR USERS

Your drug prescription is tailored for you. Do not alter dosage without checking with your doctor.

How taken/used Tablets, liquid.

Frequency and timing of doses Once daily, at bedtime.

Adult dosage range 5–10mg daily.

Onset of effect 1–2 hours.

Duration of action 24 hours or more.

Diet advice None.

Storage Keep in original container at room temperature out of the reach of children.

Missed dose If you fall asleep without having taken a dose and wake some hours later, do not take the missed dose. If necessary, return to your normal dose schedule the following night.

Stopping the drug If you have taken the drug for 2 weeks or less, it can be safely stopped. If you have been taking the drug for longer, consult your doctor, who may supervise a gradual reduction in dosage. Stopping abruptly may lead to withdrawal symptoms.

Exceeding the dose An occasional unintentional extra dose is unlikely to be a cause for concern. Large overdoses may cause unusual drowsiness. Notify your doctor.

POSSIBLE ADVERSE EFFECTS

The main adverse effects of nitrazepam are related primarily to its sedative and tranquillizing properties. The most common side effects include drowsiness the next day, confusion, forgetfulness, uncoordinated walking, dizziness, and double vision. More rarely, the drug may cause headache or vertigo. If any of these effects are severe or if you experience mood changes or restlessness, discuss with your doctor.

INTERACTIONS

Sedatives All drugs that have a sedative effect on the central nervous system are likely to increase the sedative properties of nitrazepam. Such drugs include other sleeping drugs, anti-anxiety drugs, antihistamines, opioid analgesics, antidepressants, and antipsychotics.

Rifampicin reduces the effect of nitrazepam.

Anti-epileptic drugs The side effects and toxicity of these drugs may be increased by nitrazepam.

Ritonavir may increase the blood level of nitrazepam.

SPECIAL PRECAUTIONS

Be sure to tell your doctor if:

· You have severe respiratory disease.

· You have kidney or liver problems.

· You have myasthenia gravis.

· You suffer from sleep apnoea.

· You have acute porphyria.

· You are taking other medicines.

Pregnancy Safety not established. Known to affect the baby in the womb. The baby may be born with dependence and have withdrawal symptoms. Discuss with your doctor.

Breast-feeding Avoid. Nitrazepam passes into the breast milk.

Infants and children Not recommended

Over 60 The elderly are more likely to suffer adverse effects. Reduced dose necessary.

Driving and hazardous work Do not drive. Nitrazepam’s effects are still present during the day after taking a dose. It reduces alertness, slows reactions, impairs concentration, and causes drowsiness.

Alcohol Avoid. Alcohol will add to the sedative effects.

PROLONGED USE

Not recommended. Produces tolerance and dependence.