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LUNIVIA is a brand name for Eszopiclone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lunivia is indicated for the treatment of insomnia, in adults, usually for short-term duration. Benzodiazepines or benzodiazepine-like substances are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be given for the shortest possible duration. Eszopiclone should be taken in a single intake immediately at bedtime and not be re- administered during the same night.
Posology Adults:
The recommended starting dose is 1 mg. The dose can be increased to 2 mg or 3 mg if clinically indicated. The lowest effective dose should be used. The total dose of eszopiclone should not exceed 3 mg. The length of treatment should be for the minimum duration necessary for effective treatment.
Typically, this will be no more than four weeks including the period of tapering off. 1). 4). 3). In other adult patients, the dose must not exceed 2 mg. 5).
Elderly aged 65 or older:
The recommended starting dose for elderly patients is 1 mg immediately before bedtime. In these patients, the dose may be increased to 2 mg if clinically indicated. 2). 2). 2). 2). The maximum recommended dose of eszopiclone in patients with severe renal impairment is 2 mg.
3). The safety and efficacy of eszopiclone in children and adolescents have not been established. Method of administration Lunivia is for oral use. The tablets must not be crushed or broken prior to ingestion.
8 Withdrawal syndrome. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Rebound insomnia Rebound insomnia manifested as an increase in sleep latency for one to two nights has been observed following cessation of eszopiclone treatment.
These events resolved without intervention. It is important that patients are aware of the possibility of rebound phenomena to minimise anxiety. To reduce the risk of rebound phenomena, the dose of eszopiclone should be decreased gradually.
1). Memory and psychomotor impairment Benzodiazepines and benzodiazepine-like substances, such as eszopiclone, may induce anterograde amnesia and psychomotor impairment, including accidental injury and falls. In particular elderly patients may be more vulnerable to falls resulting in injuries such as hip fractures.
Amnesia usually occurs several hours after ingesting the medicinal product. 8). 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 eszopiclone and in particular during the 12 hours following administration.
Depression and suicidality Eszopiclone should be administered with caution in patients exhibiting symptoms of depression. Eszopiclone is not a treatment for depression and may even unmask symptoms. Benzodiazepines and benzodiazepine-like substances such as eszopiclone should not be used without appropriate treatment of the depression or anxiety associated with depression (suicide may be precipitated in such patients).
1). Several epidemiological studies showed an increased incidence of suicide and suicide attempt in patients with or without depression, who were treated with benzodiazepines or other hypnotics, including zopiclone. A causal relationship was not established.
General The cause of insomnia should be identified wherever possible. The underlying factors should be treated before a hypnotic is prescribed. The lack of relief from insomnia after a 7-14 day course of treatment may indicate the presence of a primary psychiatric or physical disorder and the patient should be carefully re-evaluated.
Chronic respiratory impairment Caution should be observed when prescribing eszopiclone to patients with respiratory insufficiency since benzodiazepines and benzodiazepine-like substances have been shown to impair respiratory drive.
A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Risk from concomitant use of opioids Concomitant use of eszopiclone 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 medicinal products such as eszopiclone 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). Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
1. 4). 5) - Children and adolescent under 18 years of age.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Alcohol, substance and drug abuse/dependence Eszopiclone should be used with extreme caution in patients with current or a history of alcohol, substance and/or drug abuse or dependence. Psychiatric and "paradoxical" reactions Reactions like restlessness, aggravated insomnia, agitation, irritability, aggressiveness, delusion, rages, nightmares, parasomnia, depersonalization, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like substances.
They may be drug-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. These reactions are more likely to occur in the elderly. Any new behavioural sign or symptom requires careful and immediate evaluation and the use of eszopiclone should be discontinued.
Somnambulism and associated behaviours Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, or making phone calls or having sex, with amnesia for the event, have been reported in patients who have taken eszopiclone and were not fully awake.
The use of alcohol and other CNS-depressants with eszopiclone appears to increase the risk of such behaviours, as does the use of eszopiclone at doses exceeding the maximum recommended dose. 8). Lunivia contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
7). , antipsychotics, anxiolytics, muscle-relaxants, antiepileptics and sedative antihistamines) an enhancement of the central sedation may occur. A dose reduction for eszopiclone may be necessary when it is co-administered with agents with known CNS-depressant effects such as olanzapine.
CYP3A4 is a major metabolic pathway for elimination of eszopiclone, with a secondary contribution from CYP2E1. 2). Furthermore, the exposure of eszopiclone was increased by approximately 2-fold by co-administration of ketoconazole 400 mg daily for 5 days, a potent inhibitor of CYP3A4.
2). 3). Racemic zopiclone exposure was decreased 80% by concomitant use of rifampicin, a potent inducer of CYP3A4. A similar […]
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with Lunivia should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
Drug withdrawal syndrome Prior to starting treatment with Lunivia, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome. A withdrawal strategy for ending treatment with Lunivia should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. 8 Withdrawal syndrome. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
Rebound insomnia Rebound insomnia manifested as an increase in sleep latency for one to two nights has been observed following cessation of eszopiclone treatment. These events resolved without intervention. It is important that patients are aware of the possibility of rebound phenomena to minimise anxiety.
To reduce the risk of rebound phenomena, the dose of eszopiclone should be decreased gradually. Tolerance In clinical studies with eszopiclone, no development of tolerance to any parameter of sleep measurements was […]