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M-ESZOPICLONE is a brand name for Eszopiclone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: M-ESZOPICLONE (eszopiclone) is indicated for short-term (usually not exceeding 7-10 days) use for: • treatment and symptomatic relief of insomnia characterized by difficulty falling asleep • frequent nocturnal awakenings and/or early morning awakenings where disturbed sleep results in impaired daytime functioning (see…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3 Pediatrics]. 4 Geriatrics]. 2 Recommended Dose and Dosage Adjustment, Geriatrics).
Long-term use of M-ESZOPICLONE should be avoided, including in geriatric patients. 1 Dosing Considerations). 2 CONTRAINDICATIONS M-ESZOPICLONE (eszopiclone) is contraindicated in: • Patients who are hypersensitive to this drug or to zopiclone (marketed in Canada as IMOVANE), or to any ingredient in the formulation or component of the container.
Observed reactions to eszopiclone have included angioedema and anaphylaxis (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity). For a complete listing, see
4% of 72 patients who received 1 mg Eszopiclone tablets discontinued treatment due to an adverse reaction. In the 6 -week parallel-group study in adults, no patients in the 3 mg arm discontinued because of an adverse reaction. 8% of 593 patients who received 3 mg Eszopiclone tablets discontinued due to an adverse reaction.
No reaction that resulted in discontinuation occurred at a rate of greater than 2%. The most frequently observed adverse events during these trials were expected from the known pharmacologic properties of eszopiclone. These include unpleasant taste (dysgeusia), dizziness, somnolence, and dry mouth.
3%). 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Adverse events reported in this section were reported from a total of 11 studies that enrolled just over 4400 subjects.
These trials were conducted in patients with insomnia using nighttime administration of eszopiclone. Study duration ranged from short-term dosing (1-7 days) to 6 months, with doses ranging from 1 to 3 mg. Study populations included non-elderly adults with and without medical co-morbidities and elderly adults.
Treatment emergent adverse events (TEAEs) include those events that occurred or worsened upon or after administration of the first dose of double-blind study medication. Treatment Emergent Adverse Events in Placebo-Controlled Clinical Trials with Dosing up to 2 weeks in Elderly Subjects The most frequently reported adverse events are summarized in Table 2.
1 Dosing Considerations). 2 CONTRAINDICATIONS M-ESZOPICLONE (eszopiclone) is contraindicated in: • Patients who are hypersensitive to this drug or to zopiclone (marketed in Canada as IMOVANE), or to any ingredient in the formulation or component of the container.
Observed reactions to eszopiclone have included angioedema and anaphylaxis (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity). For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section. • Patients with myasthenia gravis.
, significant sleep apnea syndrome). • Elderly patients receiving concomitant potent CYP3A4 inhibitors or having severe hepatic insufficiency. • Patients who have experienced complex sleep-related behaviours after taking Eszopiclone tablets or any other hypnotic agent (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, COMPLEX SLEEP-RELATED BEHAVIOURS) M-ESZOPICLONE (Eszopiclone Tablets) Page 5 of 42 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, or other sedative-hypnotic drugs, such as M-ESZOPICLONE, can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.
Abuse and misuse can result in overdose or death, especially when benzodiazepines, or other sedative- hypnotic drugs, such as Mar Eszopiclone, are combined with other medicines, such as opioids, alcohol or illicit drugs. • Assess each patient’s risk prior to prescribing M-ESZOPICLONE.
• Monitor all patients regularly for the development of these behaviours or conditions. • M-ESZOPICLONE should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, or other sedative-hypnotic drugs, such as M-ESZOPICLONE, can produce severe or life-threatening withdrawal symptoms.
• Avoid abrupt discontinuation or rapid dose reduction of M-ESZOPICLONE. • Terminate treatment with M-ESZOPICLONE by gradually tapering the dosage schedule under close monitoring. (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant Use with Opioids Concomitant use of M-ESZOPICLONE and opioids may result in profound sedation, respiratory depression, coma and death (see 7 WARNINGS AND PRECAUTIONS, General, Concomitant Use with Opioids).
M-ESZOPICLONE (eszopiclone) is contraindicated in: • Patients who are hypersensitive to this drug or to zopiclone (marketed in Canada as IMOVANE), or to any ingredient in the formulation or component of the container. Observed reactions to eszopiclone have included angioedema and anaphylaxis (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section. • Patients with myasthenia gravis. , significant sleep apnea syndrome). • Elderly patients receiving concomitant potent CYP3A4 inhibitors or having severe hepatic insufficiency.
• Patients who have experienced complex sleep-related behaviours after taking Eszopiclone tablets or any other hypnotic agent (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Eszopiclone in Canada.
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Table 2. 8) 0 1: And more frequent in at least one active treatment group than the placebo group. 5%, respectively. 8%). Treatment Emergent Adverse Events in a Placebo-Controlled Clinical Trial with 6 weeks Dosing in Non-Elderly Adults The most frequently reported adverse events are summarized in Table 3.
Table 3. 3) 1: And more frequent in at least one active treatment group than the placebo group. TEAE=treatment emergent adverse event; ESZ=eszopiclone COSTART Coding, ITT Population Treatment Emergent Adverse Events in Placebo-Controlled Clinical Trials with Dosing up to 6-months in Non-Elderly Adults The types of adverse events reported were similar to those observed during the 6 -week trial in M-ESZOPICLONE (Eszopiclone Tablets) Page 18 of 42 the same population.
4%). Treatment-Emergent Adverse Events in Patients with Medical Co-morbidities In 2 clinical studies of 8 weeks duration where eszopiclone was administered in combination with a selective serotonin reuptake inhibitor (SSRI) in non-elderly adults with Major Depressive Disorder or General Anxiety Disorder, incidences of adverse events were usually similar between the placebo and the eszopiclone groups.
Adverse events that were […]
• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation.
Complex Sleep-Related Behaviours:
Complex sleep behaviours including sleepwalking, sleep-driving, and engaging in other activities while not fully awake may occur following use of non-benzodiazepine sedative- hypnotics. Some of these events may result in serious injuries, including death.
Discontinue M-ESZOPICLONE immediately if a patient experiences a complex sleep behavior. 1 Dosing Considerations • Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated.
• The use of hypnotics should be restricted for insomnia where disturbed sleep results in M-ESZOPICLONE (Eszopiclone Tablets) Page 6 of 42 impaired daytime functioning. • The length of treatment should be for the minimum duration necessary for the patient.
Treatment with M-ESZOPICLONE should usually not exceed 7-10 consecutive days. Use for more than 2-3 consecutive weeks requires complete re-evaluation of the patient. Prescriptions for M-ESZOPICLONE should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply.
• M-ESZOPICLONE should always be prescribed at the lowest effective dose for the shortest duration possible. Discontinuation • M-ESZOPICLONE can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance; 8.
). • Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring. • Tapering should be tailored to the specific patient.
Special attention should be given to patients with a history of seizure. • If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising M-ESZOPICLONE to the previous dosage prior to proceeding with a gradual taper.
Geriatric • Geriatric patients in particular may be more sensitive to M-ESZOPICLONE (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures). • Long-term use of M-ESZOPICLONE should be avoided, including in geriatric patients. Enhanced monitoring is recommended.
2 Recommended Dose and Dosage Adjustment The recommended starting dose is 1 mg. The dose can be increased to 2 mg or 3 mg if clinically indicated. Use the lowest effective dose of M-ESZOPICLONE possible for the patient. In some patients, the higher morning blood levels of M-ESZOPICLONE following use of the 2 mg or 3 mg dose, increase the risk of next day impairment of driving and other activities that require full alertness.
The total dose of M-ESZOPICLONE should not exceed 3 mg, once daily immediately before bedtime (see 7 WARNINGS AND PRECAUTIONS, CNS Depressant Effects and Next-Day Impairment). Geriatrics (> 65 years of age) In elderly or debilitated patients, the total dose of M-ESZOPICLONE should not […]