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Brand Name: Sedaben

Other Brand Names: Noctamid, Ergocalm, Loramet, Dilamet, Stilaze, Nocton, Pronoctan, Noctamide, Loretam, Minias, Aldosomnil

Generic Name: Lormetazepam

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Why are Sedaben prescribed sleeping tablets?

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

Contra indications with Sedaben sleeping tablets

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

Use in pregnancy:
The safety of Sedaben 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 Sedaben is prescribed to a woman of child-bearing potential she should be warned to contact her doctor regarding discontinuation of Sedaben 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:
Sedaben 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 Sedaben sleeping tablets

As with all central nervous system depressants, patients receiving Sedaben 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 Sedaben 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 Sedaben .

Withdrawal fromSedaben 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 As with other sedative/hypnotics when treatment is suddenly withdrawn, a temporary increase of sleep disturbance can occur after long term daily use of Sedaben.

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

Recommended dosages for Sedaben sleeping tablets
The dosage of Sedaben 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 Sedaben 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 Sedaben, 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.

Sedaben interaction with other medicines:

Sedaben 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 Sedaben 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 Sedaben 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 Sedaben should be terminated gradually to help avoid occurrence of withdrawal symptoms.

Overdosage with Sedaben 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 Sedaben 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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