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ZOPICLONE is a brand name for Zopiclone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Zopiclone is indicated for the short-term treatment of insomnia in adults. Benzodiazepines or benzodiazepine-like agents is only indicated in cases where the insomnia is severe, disabling or subjecting the individual to extreme distress.
Verbatim from this product's MHRA label. Tap a section to expand.
Use the lowest effective dose. Zopiclone should be taken in a single intake and not be re-administered during the same night. As with all hypnotics, long term use of zopiclone is not recommended. Treatment should be as short as possible (few days to two weeks) and should not exceed four weeks including the period of tapering off.
4). Posology Paediatric population Zopiclone should not be used in children and adolescents less than 18 years. The safety and efficacy of zopiclone in children and adolescents aged less than 18 years have not been established. 5mg. 75 mg zopiclone should be employed to start treatment.
Depending on effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary. 75mg Zopiclone is recommended to start treatment. 5 mg if clinically necessary. Patients with Renal impairment Accumulation of zopiclone or its metabolites has not been seen during treatment of insomnia in patients with renal insufficiency.
75mg. 75 mg zopiclone. 5 mg if clinically necessary. Method of administration For oral use only. Zopiclone should be taken immediately before bedtime. Each tablet should be swallowed whole without sucking, chewing or breaking.
Most side effects are due to high doses and regular use every night. Around 10% of the treated patients experiences side effects. Side effects such as drowsiness in the daytime, reduced emotional state, reduced attention, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision occur mainly at the start of the treatment and usually disappears during continued treatment.
The most common side effects are taste changes (about 4 % of those treated), dry mouth and morning tiredness. The adverse drug reactions are stated in the table below using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Immune system disorders Very rare (<1/10,000) Angioedema, anaphylactic reaction Psychiatric disorders Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data). Agitation, nightmare.
Confusional state, libido disorder, irritability, aggression, hallucination and depression. 4), dependence and withdrawal syndrome II. Nervous system disorders Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data).
Dysgeusia (bitter taste or metallic aftertaste), somnolence (residual). Reduced alertness, headache, dizziness. Anterograde amnesia. Ataxia, paraesthesia, cognitive disorders such as memory impairment, disturbance in attention, speech disorder.
Eye disorders Not known (cannot be estimated from the available data). Diplopia Respiratory, thoracic and mediastinal disorders Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data). 4) Gastrointestinal disorders Common (≥1/100 to Dry mouth <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data).
8). A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Use in Psychomotor impairment Like other sedative/hypnotic drugs, zopiclone has CNS-depressant effects. 5).
Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle following administration of zopiclone and in particular during the 12 hours following that administration.
Tolerance Some loss of the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. However, with Zopiclone there is an absence of any marked tolerance during treatment periods of up to 4 weeks.
8). Cases of dependence have been reported more frequently in patients treated with zopiclone for longer than 4 weeks. The risk of dependence increases with dose and duration of treatment. The risk of abuse and dependence is also greater in patients with a history of psychiatric disorders and/or alcohol, substance or drug abuse.
Zopiclone should be used with extreme caution in patients with current or a history of alcohol, substance or drug abuse or dependence. Rebound effect A transient syndrome whereby the symptoms that led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form may occur on withdrawal of hypnotic treatment.
It may be accompanied by other reactions including mood changes, anxiety and restlessness. As the risk of withdrawal symptoms/rebound phenomena are most likely to develop after abrupt discontinuation of treatment, especially when the treatment is of longer duration, it is recommended to decrease the dose gradually.
2), but should not exceed four weeks including the tapering off process. Extension beyond the maximum treatment period should not take place without re-evaluation of the patient's status. It may be useful to inform the patients, when treatment is started, that it will be of limited duration and explain precisely how the dosage can be gradual reduced.
1 • Myasthenia gravis • Severe respiratory failure • Severe sleep apnoea syndrome • Children and adolescents less than 18 years. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Nausea, malaise, abdominal pain. Vomiting Dyspepsia Hepatobiliary disorders Very rare (<1/10,000) Mild to moderate increase in transaminases and/or blood alkaline phosphatase. Skin and subcutaneous tissue disorders Rare (≥1/10,000 to <1/1,000) Allergic skin reaction (inclusive rash, pruritus, urticaria).
Musculoskeletal and connective tissue disorders Not known (cannot be estimated from the available data). Muscular weakness General disorders and administration site conditions Uncommon (≥1/1,000 to <1/100) Not known (cannot be estimated from the available data).
Difficulty getting up in the morning, fatigue. 4). 4). Psychic dependence may occur. Abuse has been reported. 4). Withdrawal symptoms vary and can take the form of insomnia, muscle aches, anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, panic attacks, muscle aches/cramps, gastrointestinal disturbances and irritability.
In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact, hallucinations and epileptic seizures.
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.
It is also important to make the patient aware of the possibility of rebound effect, so the patient dose not unnecessary worry about these types of symptoms when tapering off the treatment. For short-acting benzodiazepines or benzodiazepine-like substances, signs of withdrawal symptoms may occur within the dose range, especially if the dosage is high.
Risks from concomitant use with opioids Concomitant use of opioids with benzodiazepines or other sedative-hypnotic drugs, including zopiclone may result in sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of opioids and benzodiazepines for use in patients for whom alternative treatment options are inadequate.
5). Anterograde amnesia Benzodiazepines or benzodiazepine-like agents may induce anterograde amnesia, especially a few hours after ingesting of the preparation. Anterograde amnesia usually happens when sleep is interrupted or when retiring to bed is delayed after taking the tablet.
8). Psychiatric and paradoxical reactions Reactions like restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, delirium, inappropriate behaviour and other adverse behavioural effects are known to occur when using sedative/hypnotic agents like zopiclone.
Should this occur, use of zopiclone should be discontinued. These reactions are more likely to occur in the elderly. Somnambulism and associated behaviours Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, or making phone calls, with amnesia for the event, have been reported in patients who have taken zopiclone and were not fully awake.
These events may occur following the first or any subsequent use of zopiclone. The use of alcohol and other CNS-depressants with zopiclone appears to increase the risk of such behaviour, as does the use of zopiclone at doses exceeding the maximum recommended dose.
Discontinuation of zopiclone should be strongly considered for patients who report such behaviours due to the risk to the patient and others. 5). Suicidal ideation/suicide attempt/suicide and depression As with other hypnotics, zopiclone does not constitute a treatment for depression but can in some cases mask it (suicide may be precipitated in such patients).
Some epidemiological studies show an increased incidence of suicidal ideation, suicide attempt and suicide in patients […]