TEMAZEPAM

Posology Insomnia Adults:

The usual dose is 5 - 15ml (10-30mg) orally on retiring; a dose of 10ml (20mg) will be found to be satisfactory for most patients. This may be increased to 15 - 20ml (30 - 40mg) in patients who do not respond to the lower dose. Lower doses may be adequate for some patients, as for the elderly.

Pre-medication 10 - 20ml (20 - 40mg) from half an hour to one hour prior to surgery or investigative procedures.

Elderly:

Elderly patients or those suffering from cerebral vascular changes such as arteriosclerosis are likely to respond to smaller doses. 5ml (5 - 15mg) may be sufficient for a therapeutic response. 5ml)/kg one hour prior to surgery or investigative procedures.

Treatment should if possible be intermittent. The lowest dose which can control symptoms should be used. It should not be continued beyond 4 weeks. Long term chronic use is not recommended. Treatment should always be tapered off gradually.

Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced. Method of administration For oral administration only.

At the start of treatment patients may suffer from drowsiness, light-headedness the next day; confusion and ataxia (especially in the elderly); amnesia may occur and dependence. Reduced alertness, dizziness, muscle weakness, fatigue, numbed emotions, double vision, unsteadiness, respiratory depression or slurred speech.

These will normally disappear with continued treatment. More rarely, headache, vertigo, hypotension, salivation changes, visual disturbances, dysarthria, tremor, incontinence, urinary retention, blood disorders, jaundice, vivid dreams/nightmares, restless sleep, palpitations, change in libido, skin reactions, sedation, impaired muscular function, dry mouth and gastro-intestinal disturbances may occur.

Severe anaphylactic and anaphylactoid reactions, including rare cases of fatal anaphylaxis, have been reported in patients receiving temazepam. Pre-existing depression may be unmasked during treatment with temazepam. Blood dyscrasias and increased liver enzymes have also been reported to occur occasionally.

If any of these effects do occur, treatment should be discontinued. Other effects, including delusions, psychoses, hallucinations, psychoses, irritability and restlessness, agitation, aggressiveness, nightmares and rages or other inappropriate behaviour and other adverse behavioural effects have also been reported to occur.

They are more likely to occur in children and in the elderly. If any of these effects occur, treatment should be discontinued.

Dependence:

Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of therapy may result in withdrawal of rebound phenomena (See warnings and precautions). Psychological dependence may occur. Abuse of benzodiazepines has been reported.

Withdrawal effects on abrupt cessation of treatment:

Depression, anxiety, headache, dizziness, impaired concentration, tinnitus, loss of appetite, tremor, perceptual disturbances, nausea, vomiting, abdominal cramps, palpitations, mild systolic hypertension, tachycardia, orthostatic hypotension, photophobia, hyperacusis, confusion, tension, nervousness, rebound insomnia, irritability, sweating and diarrhoea have been reported following abrupt cessation of treatment.

In rare cases, withdrawal following excessive dosages may produce confusional states, psychotic manifestations and convulsions. Broken sleep with vivid dreams may persist for some weeks after withdrawal. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief; benzodiazepines should not be used for first line treatment of psychotic illness. Severe anaphylactic and anaphylactoid reactions, including rare fatal cases of anaphylaxis, have been reported in patients receiving temazepam.

Cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including temazepam. Where temazepam is used as a medication before surgical or investigative procedures, the patients should be accompanied home.

2) depending on the indication, but should not exceed 4 weeks for insomnia, including tapering off process. Extension beyond these periods should not take place without re-evaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.

Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur while temazepam is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action such as temazepam, withdrawal phenomena can become manifest between doses, especially when the dosage is high.

When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop.

Tolerance:

Limit of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardiorespiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients. Some loss of efficacy to the hypnotic effects of short acting benzodiazepines may develop after repeated use for a few weeks.

Temazepam should be given with caution to patients with chronic pulmonary insufficiency, or those with renal or hepatic dysfunction. Sedatives given to patients with cirrhosis may precipitate encephalopathy. Doses of 30mg and above are more likely to cause hangover effects to persist into the following day than lower doses, particularly in patients unused to hypnotics and in the elderly.

As with all compounds which have an effect on the CNS, patients should be advised not to consume alcohol whilst taking temazepam. Dependence In general, the dependence potential of benzodiazepines is low, but this increases when high dosage is used, especially when given over long periods.

This is particularly so in patients with a history of alcoholism, drug abuse or in patients with marked personality disorders. Regular monitoring of treatment in such patients is essential, routine repeat prescriptions should be avoided and the treatment should be withdrawn gradually.

Withdrawal effects Treatment in all patients should be withdrawn gradually as symptoms such as mood changes, nervousness, sleep disturbance, irritability, sweating, headaches, dizziness, impaired concentration, tinnitus, loss of appetite, tremor, perceptual disturbances, nausea, vomiting, abdominal cramps, palpitations, mild systolic hypertension, tachycardia, orthostatic hypotension, photophobia, hyperacusis, muscle pain, extreme anxiety, tension, restlessness, confusion and diarrhoea have been reported following abrupt cessation of treatment with benzodiazepines in patients receiving even normal therapeutic doses for short periods of time.

Abrupt withdrawal following excessive dosage may produce confusion, toxic psychosis, convulsions, derealisation, depersonalisation, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations, epileptic seizures or a condition resembling delirium tremens.

Broken sleep with vivid dreams may persist for some weeks after withdrawal. Rebound symptoms Symptoms including insomnia and anxiety may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.

2). Amnesia Anterograde amnesia may occur, most often several hours after ingestion. 8). Insufficient sleep may adversely affect the ability to drive/operate machinery etc. 7). Loss or bereavement Psychological adjustment may be inhibited by benzodiazepines.

Psychiatric and ‘paradoxical’ reactions Reactions like restlessness, agitation, irritability, aggressiveness, excitement, confusion, delusion, rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines.

These reactions are more likely to occur in children and in the elderly, and extreme caution should be used in prescribing benzodiazepines to patients with personalities disorders. Should this occur, use of the product should be discontinued.

e. driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients who are not fully awake after taking a sedative- hypnotic, including triazolam. These events can occur with sedative-hypnotics, including temazepam, alone at therapeutic doses.

The use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviours, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of sedative- hypnotics should be […]

1. • Neuromuscular respiratory weakness including myasthenia gravis (condition may be exacerbated). • Acute pulmonary insufficiency, severe respiratory depression, sleep apnoea syndrome (risk of further respiratory depression) or CNS depression.

• Severe hepatic insufficiency (may precipitate encephalopathy. Elimination half-life of temazepam may be prolonged). • Phobic or obsessional state; chronic psychosis (paradoxical reactions may occur. Inadequate evidence of safety and efficacy).

• Mild anxiety states. • Acute narrow angle glaucoma (due to anticholinergic effects of temazepam). • As monotherapy in patients with depression or those with anxiety and depression (suicide may be precipitated in these patients). • Breast-feeding.