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LUNESTA 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: , 4 DOSAGE AND ADMINISTRATION). Patients should be instructed not to exceed the recommended dose. Caution should be exercised with concomitant use of potent CYP3A4 inhibitors (see 9 DRUG INTERACTIONS). Dependence/Tolerance Use of benzodiazepines or other sedative-hypnotic drugs, such as LUNESTA, can lead to abuse,…
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 LUNESTA should be avoided, including in geriatric patients. 1 Dosing Considerations). 2. CONTRAINDICATIONS LUNESTA (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
1 Dosing Considerations). 2. CONTRAINDICATIONS LUNESTA (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 LUNESTA or any other hypnotic agent (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, COMPLEX SLEEP-RELATED BEHAVIOURS) 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 LUNESTA, can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.
Abuse and PrLUNESTA® (eszopiclone) Page 5 of 43 misuse can result in overdose or death, especially when benzodiazepines, or other sedative- hypnotic drugs, such as LUNESTA, are combined with other medicines, such as opioids, alcohol or illicit drugs.
• Assess each patient’s risk prior to prescribing LUNESTA. • Monitor all patients regularly for the development of these behaviours or conditions. • LUNESTA should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, or other sedative-hypnotic drugs, such as LUNESTA, can produce severe or life-threatening withdrawal symptoms.
• Avoid abrupt discontinuation or rapid dose reduction of LUNESTA. • Terminate treatment with LUNESTA 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 LUNESTA and opioids may result in profound sedation, respiratory depression, coma and death (see 7 WARNINGS AND PRECAUTIONS, General, Concomitant Use with Opioids).
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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• 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 sleep-walking, 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 LUNESTA immediately if a patient experiences a complex sleep behavior. (See 7 WARNINGS AND PRECAUTIONS, Complex Sleep-related Behaviours) 4. 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 impaired daytime functioning.
• The length of treatment should be for the minimum duration necessary for the patient. Treatment with LUNESTA 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 LUNESTA should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply. PrLUNESTA® (eszopiclone) Page 6 of 43 • LUNESTA should always be prescribed at the lowest effective dose for the shortest duration possible.
Discontinuation • LUNESTA 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 LUNESTA to the previous dosage prior to proceeding with a gradual taper.
Geriatric • Geriatric patients in particular may be more sensitive to LUNESTA (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures). • Long-term use of LUNESTA should be avoided, including in geriatric patients. Enhanced monitoring is recommended.
Food effect • Taking LUNESTA with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of LUNESTA on sleep latency (see 10 CLINICAL PHARMACOLOGY). 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 LUNESTA possible for the patient. In some patients, the higher morning blood levels of LUNESTA 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 LUNESTA 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 LUNESTA should not exceed 2 mg.
Pediatrics (< 18 years of age) LUNESTA is not indicated for patients under 18 years of age. Hepatic Impairment, Renal Impairment or Use with Potent CYP 3A4 […]