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Brand Name: Pronoctan

Generic name: Lormetazepam

Why are Pronoctan sleeping tablets prescribed ?

Pronoctan is indicated for use as a sedative/hypnotic. Since insomnia is often transient and intermittent, the prolonged administration of Pronoctan is not recommended.

Sleepiness can result to various risky and more complicated medical problems. This is a condition any individual cannot just ignore. Sleepiness may either be a result of inability to fall asleep or inability to maintain sleep due to frequent awakening or early awakenings. This condition is called insomnia.

Insomnia is said to be a temporary sleeping disorder which should only last a few days. If it is experienced for a long period of time or longer than two weeks, a patient should be re-examined as it could be a symptom of another medical problem.

While some patients only need a nice place to sleep to treat insomnia, others need the help of medicines. One of the most commonly prescribed treatments for insomnia is Pronoctan.

Pronoctan has sedative, hypnotic and skeletal muscle relaxant properties that enable it to induce sleep. It is also generically known as Lormetazepam or sometimes known as Methyllorazepam.

Although Pronoctan is a prescribed medication for insomnia, because of its sedative-hypnotic side effects, it is currently being controlled in the market and is not even available in the United States and in Canada. In some other countries, it could only be purchased with medical prescription and is considered illegal without it.

Pronoctan comes available in some countries at 0.5 mg, 1 mg and 2 mg tablets. It is used as a short-term treatment to insomnia.

There are also other trade names that share the same generic as Pronoctan’s. These trade names include Nctamid, Ergocalm, Sedaben, Loretam, Loramet, Minias, Aldosomnil, Dilamet, Nocton and Noctamide.

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Contra indications with Pronoctan sleeping tablets

Lormetazepam is contra-indicated in patients with known hypersensitivity to benzodiazepines.

Use in pregnancy:
The safety of Pronoctan in pregnancy has not been established.
Benzodiazepines may cause foetal damage when administered to pregnant women. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery, have been reported to have withdrawal symptoms during the postnatal period. The use of benzodiazepines during pregnancy should be avoided.
If Pronoctan is prescribed to a woman of child-bearing potential she should be warned to contact her doctor regarding discontinuation of Pronoctan if she intends to become or suspects that she is pregnant.

Use in labour:
Given during labour or the late phase of pregnancy, benzodiazepines cross the placenta and may cause the floppy infant syndrome, characterised by central respiratory depression, hypothermia and poor sucking.

Use in nursing mothers:
Pronoctan should not be administered to nursing mothers.

Use in children:
The safety and effectiveness of lormetazepam in children has not been established.

Special warnings with Pronoctan sleeping tablets

As with all central nervous system depressants, patients receiving Pronoctan should be warned not to operate dangerous machinery or motor vehicles, or climb dangerous heights until it is known that they do not become drowsy or dizzy from Pronoctan therapy. Patients should be advised that their tolerance for alcohol and other central nervous system depressants will be diminished and should either be eliminated or given in reduced dosage in the presence of Pronoctan .

Withdrawal fromPronoctan should be gradual. As with other sedative/hypnotics when treatment is suddenly withdrawn, a temporary increase of sleep disturbance can occur after long term daily use of Pronoctan.

It is recommended that the need for continued therapy with Pronoctan be determined periodically.

Recommended dosages for Pronoctan sleeping tablets
The dosage of Pronoctan should be individualised for maximum beneficial effect.
The recommended oral adult dose is 1 mg to 2 mg, and 0,5 mg to 1 mg in elderly patients.
A dose of 2 mg is recommended the night before surgery.
For elderly and debilitated patients, the initial daily dose should generally not exceed 1 mg in order to avoid over-sedation.
The capsules should be taken with water half an hour before retiring.

Side Effects and Special Precautions for Pronoctan sleeping tablets

The adverse effects most commonly encountered with benzodiazepine usage are drowsiness and oversedation.
Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses.

Less commonly, the benzodiazepines may produce headache, depression of mood and affect, disorientation or confusion, lethargy and ataxia, sleep disturbance, and dermatological or gastro-intestinal symptoms.

Paradoxical reactions with acute hyperexcitable states with rage have been recorded with other benzodiazepines. If these occur with Pronoctan, its use should be discontinued.
Caution should be exercised in patients suffering from insomnia accompanied by an underlying depressive disorder.

Caution should be exercised in the treatment of patients with acute narrow-angle glaucoma.
The usual precautions for treating patients with impaired renal or hepatic function should be observed.

Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.

Some patients on benzodiazepines have developed blood dyscrasias, and some have had elevations in liver enzymes.

As with other benzodiazepines, periodic blood counts and liver-function tests are recommended for patients on long-term therapy.

In doses 50 -100 times those recommended clinically, no evidence of toxicity, teratogenicity or embryotoxicity was found in the animal species tested. There was no evidence of cytotoxic, mutagenic or carcinogenic effects.

Pronoctan interaction with other medicines:

Pronoctan produces additive central nervous system depressant effects when co-administered with other medications which themselves produce central nervous system depression eg. barbiturates or alcohol.

Abuse with Pronoctan sleeping tablets

Benzodiazepines have a potential for abuse.
Addiction-prone individuals, such as drug addicts and alcoholics, should be under careful surveillance when receiving benzodiazepines because of the predisposition of such patients to habituation and dependence.

Dependence with Pronoctan sleeping tablets

The use of benzodiazepines may lead to dependence. Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance of benzodiazepines. These symptoms can range from mild dysphoria and insomnia to a major syndrome which may include: convulsions, tremor, abdominal and muscle cramps, vomiting and sweating.

These symptoms, especially the more serious ones, are more common in those patients who have received excessive doses over an extended period of time. However, withdrawal symptoms have also been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels. Accordingly Pronoctan should be terminated gradually to help avoid occurrence of withdrawal symptoms.

Overdosage with Pronoctan sleeping tablets
Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.
Induced vomiting and/or gastric lavage should be undertaken followed by general supportive care.

Storage instructions for Pronoctan sleeping tablets

Store in tightly closed containers, protected from light in a cool (below 25°C), dry place.
Keep out of reach of children.

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