Hypnol

Indications

Nitrazepam is used for the short-term treatment of severe sleeplessness (insomnia) that is disabling or causing great distress, when other measures have not helped. In some countries it is also used, under specialist care, for certain types of epilepsy in infants and children.

How It Works

Nitrazepam belongs to the benzodiazepine group. It boosts the effect of GABA, a natural calming chemical in the brain, which slows down nerve activity. This reduces anxiety, relaxes the muscles and helps a person fall asleep and stay asleep.

Dosage and Administration

For insomnia in adults the usual dose is 5 mg to 10 mg taken at bedtime; older or frail adults usually start with 2.5 mg to 5 mg. Use for the shortest time possible, usually no longer than 2 to 4 weeks, as prescribed. Doses for children with epilepsy are set by the specialist, as prescribed. Do not stop suddenly after regular use; your doctor will reduce the dose slowly.

Interactions

• Alcohol, opioid pain relievers (e.g. Tramadol, Codeine), other sleeping pills, sedating antihistamines, antipsychotics and some antidepressants increase drowsiness and can dangerously slow breathing.
• Cimetidine, Erythromycin, Ketoconazole and some HIV medicines may raise Nitrazepam levels.
• Rifampicin and some anti-epileptics such as Phenytoin may lower its effect.

Contraindications

• Allergy to Nitrazepam or other benzodiazepines.
• Severe breathing problems, sleep apnoea or severe lung disease.
• Myasthenia gravis (a muscle-weakness disease).
• Severe liver disease.
• Phobias or long-term psychosis treated alone with this medicine.

Side Effects

Common effects include drowsiness the next day, dizziness, unsteadiness, slowed thinking, poor concentration, memory lapses and muscle weakness. Older people are at higher risk of falls. Dependence can develop with regular use, and stopping suddenly can cause withdrawal symptoms such as anxiety, shaking, sweating and, rarely, seizures.

Get urgent medical help if you have slowed or shallow breathing, extreme drowsiness, confusion, unusual agitation or aggression, thoughts of self-harm, or signs of a severe allergic reaction.

Pregnancy and Lactation

Avoid during pregnancy, especially in late pregnancy, as it can cause breathing problems, floppiness and withdrawal in the newborn. It passes into breast milk and can make the baby drowsy; avoid while breastfeeding unless your doctor advises.

Precautions and Warnings

Nitrazepam can cause dependence and should be used only for a short time. Do not drive or operate machinery if you feel drowsy, and avoid alcohol. Use with care in the elderly and in people with lung, liver or kidney disease, depression or a history of drug or alcohol misuse. Keep it safely stored and never share it.

Overdose

Overdose causes deep sleep, confusion, poor coordination, slurred speech, low blood pressure and slowed breathing, which can be life-threatening, especially with alcohol or opioids. Seek emergency medical help at once.

Therapeutic Class

Hypnotic (sleep-inducing medicine), benzodiazepine.

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.