Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.
The duration of treatment should be as short as possible (see Posology and method of administration) 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 reevaluation 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.
Withdrawal symptoms occur with benzodiazepines following normal therapeutic doses given for short periods of time.
Use of temazepam may lead to the development of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment, it is also greater in patients with a history of alcoholism or drug abuse.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with temazepam may recur in an enhanced form on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.
Limits 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 temazepam may develop after repeated use for a few weeks.
Care should be taken in patients with chronic renal or hepatic disease (elimination half-life of temazepam may be prolonged). Sedatives given to patients with cirrhosis may precipitate encephalopathy.
Alcohol should be avoided during treatment with temazepam (additive CNS depression).
Temazepam may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have uninterrupted sleep of 7-8 hours (see undesirable effects section 4.8).
Concomitant use of Temazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Temazepam with opioids should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Temazepam concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of these symptoms (see section 4.5).
Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, use of the medicinal product should be discontinued.
Elderly should be given a reduced dose. (see section 4.2). A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.
Psychiatric and paradoxical reactions are more likely to occur in the elderly.
Due to muscle relaxant effects, benzodiazepines increase the risk of falls (and consequently hip fractures, etc) particularly in the elderly when they get up at night (See section 4.2 – reduced dosage elderly patients).
Psychiatric and paradoxical reactions are more likely to occur in children.
Benzodiazepines are not recommended for the primary treatment of psychotic illness.
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).
Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.
In case of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.
Extreme caution should be used in prescribing temazepam to patients with personality disorders.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The following drug interactions with temazepam should be considered:
Take in to account: combination with CNS depressants
Enhancement of other CNS depressant drugs such as antipsychotics (neuroleptics), anxiolytics and sedatives, anti-epileptic products, narcotic analgesics (enhancement of euphoria may also occur, leading to an increase in psychological dependence), antidepressants, MAOIs, hypnotics, anaesthetics, sedative antihistamines, lofexidine, nabilone.
Opioids – The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Temazepam with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see section 4.4).
Alcohol – concomitant intake with alcohol is not recommended. The sedative effects may be enhanced when temazepam is used in combination with alcohol. This further affects the ability to drive or use machines.
Antiepileptic drugs – plasma phenytoin concentrations increased or decreased by temazepam, Phenytoin levels may need monitoring during temazepam withdrawal. Side effects may be more evident with hydantoins or barbiturates.
Antihypertensives – enhanced hypotensive effects. Enhances sedative effect with alpha blockers or moxonidine.
Antivirals -Concurrent use of zidovudine with benzodiazepines may decrease Zidovudine clearance. Ritonavir may inhibit benzodiazepine hepatic metabolism.
Clozapine – reports of cardiorespiratory collapse. Also increase in hypersalivation with both drugs.
Disulfiram – inhibits the metabolism of benzodiazepines and enhances sedative effect. May cause temazepam toxicity.
Dopaminergics -concurrent use with benzodiazepines may decrease the herapeutic effects of levodopa.
Muscle relaxants – Baclofen and Tizanidine -enhanced sedative effect.
Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines. To a lesser degree this also applies to benzodiazepines that are metabolised only by conjugation.
The safety of temazepam has not been evaluated in humans and therefore its use should be avoided, especially in the first and third trimester.
If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant. If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.
Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Since benzodiazepines are found in the breast milk, benzodiazepines should not be given to breast feeding mothers.
Sedation, visual disturbances, impaired concentration, amnesia and impaired muscular function may adversely affect the ability to drive or use machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see also Interactions).
Impaired function and sedation may occur the following morning. This may not be apparent. Patients should make sure they are not affected before driving or operating machinery.
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
The following phenomena occur predominantly at the beginning of therapy and may disappear with repeated administration: drowsiness (when the product is used as a hypnotic it should be stated explicitly: drowsiness during the day), numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision, respiratory depression or slurred speech. These phenomena occur predominantly at the start of therapy and usually disappear with repeated administration.
Other adverse reactions like gastrointestinal disturbances, hypotension, changes in libido, dry mouth, restless sleep, dreams/nightmares, dysarthria, tremor, visual disturbances, hypersalivation, hypersensitivity, skin rashes, incontinence, urinary retention, blood dyscrasias and jaundice have been reported occasionally.
Amnesia: Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour (see warnings and precautions).
Depression: Pre-existing depression may be unmasked during benzodiazepine use.
Psychiatric and paradoxical reactions: Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents. They may be quite severe with this product. They are more likely to occur in children and the elderly.
Dependence: Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or 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.
Psychiatric and paradoxical reactions are more likely to occur in children.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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