). Treatment with sleeping pills should be temporary or intermittent to reduce the risk of withdrawal problems. 2) but not longer than 4 weeks including the tapering off process. This period should only be exceeded after re-evaluation of the patient’s status.
It may be of benefit to inform the patient at the beginning of treatment that the treatment will be of short duration, and to explain precisely how to reduce the dose gradually. It is also important to draw attention to the possibility of a rebound effect, so the patient does not worry unduly about these symptoms during the treatment withdrawal.
Psychomotor impairment Like any other sedative/hypnotic medicine, zopiclone has CNS-depressant effects. Alterations in psychomotor functions are likely to appear within hours of administration. 5). , operating machinery or driving) after taking zopiclone, and especially during the first 12 hours after administration.
Anterograde amnesia Anterograde amnesia may occur, especially if sleep is interrupted or if bedtime is delayed after taking Zopiclone Grindeks. Anterograde amnesia could appear within hours of administration. To reduce the risk of anterograde amnesia, the patient should be advised to: - take the tablet immediately before bedtime or when already in bed, - create the most favourable conditions for a full night's sleep (7-8 hours).
Somnambulism and associated behaviours Sleepwalking and other associated complex sleep behaviours such as ‘sleep driving’, cooking and eating, having sex or making phone calls in sleep, with amnesia for the event, have been reported in patients who have taken the first or any subsequent dose of zopiclone and have not been awaken enough.
Patients usually do not remember these events. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. The use of alcohol and other CNS depressants with zopiclone may increase the risk of such behaviour or when the maximum recommended dose is exceeded.
5). Other psychiatric and paradoxical reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychosis, inappropriate behavior and other behavioral disturbances may occur during treatment with benzodiazepines and benzodiazepine-like agents.
In this case, the medicinal product must be discontinued. These reactions occur more often in the elderly. Suicide / Depression / Major depressive episode Some epidemiological studies show an increased incidence of suicidal ideation, suicide attempts and suicides in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zopiclone.
However, a causal relationship has not been established. As with other hypnotics, zopiclone does not constitute a treatment for depression and may even mask its symptoms (suicide may be precipitated in such patients).
In persons with major depressive episode:
Benzodiazepines and benzodiazepine-like medicinal products should not be prescribed as monotherapy as this may allow the underlying depression to evolve and become persistent, leading to an increased risk of suicide. Because of the suicidal risk in these patients, the lowest possible dose of zopiclone should be used to these patients to avoid the possibility of intentional overdose.
Risks of concomitant use of opioids Concomitant use of Zopiclone Grindeks 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 Zopiclone Grindeks with opioids should be reserved for patients for whom alternative treatment options are not possible.
2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 2. 3). Respiratory impairment A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.
2). 2). There is a risk of fall, particularly in the elderly when they get up during the night due to the muscle relaxing effect of zopiclone. Paediatric population Zopiclone Grindeks should not be administered in children and adolescents under 18 years of age.
The safety and efficacy of zopiclone in this group have not been established. , is essentially 'sodium-free'. 5 Interaction with other medicinal products and […]