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Important Safety Information

Indications:

LUNESTA (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.

Geriatrics (>65 years of age): There is a risk for greater sensitivity to the drug effects in the elderly. A lower maximum dose is recommended in the elderly. Long-term use of LUNESTA should be avoided. Enhanced monitoring is recommended.

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

Contraindications:

  • 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
  • Patients with myasthenia gravis
  • Severe respiratory impairment (e.g., 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

Most 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 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.

RISKS FROM CONCOMITANT USE WITH OPIOIDS: Concomitant use of LUNESTA and opioids may result in profound sedation, respiratory depression, coma, and death.

  • 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 behaviour.

Other Relevant Warnings and Precautions:

  • The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated
  • Possibility of development of tolerance
  • Possibility of rebound insomnia
  • CNS depressant effects and next-day impairment: caution in patients operating machinery or driving after ingesting the drug
  • Patient counseling information regarding next-day impairment
  • Falls and fractures
  • Severe anaphylactic and anaphylactoid reactions
  • Anterograde amnesia
  • Psychomotor impairment, including accidental falls and injury (elderly in particular)
  • Alteration in cognitive function, particularly in elderly and in patients with cerebral impairment
  • Daytime anxiety/restlessness
  • Abnormal thinking and behavioural changes
  • Primary depression: worsening of depression, including suicidal thoughts and actions (including completed suicides) have been associated with the use of sedative/hypnotics. Intentional overdose is more common in this group of patients
  • Caution in patients with compromised respiratory function
  • Not recommended in pregnancy or nursing women
  • Safety and efficacy of eszopiclone in children below the age of 18 have not been established
  • Concomitant use with alcohol and other CNS-depressants may enhance the sedative effects

Adverse Events:
Adverse reactions reported at a frequency of >2% in clinical studies of LUNESTA 1 mg and 2 mg administered for up to 2 weeks of treatment in elderly subjects included: headache, pain, accidental injury, dry mouth, diarrhoea, dyspepsia, somnolence, dizziness, nervousness, abnormal dreams, neuralgia, pruritus, rash, unpleasant taste, urinary tract infection.

Adverse reactions reported at a frequency of >2% in clinical studies of LUNESTA 2 mg and 3 mg administered for up to 6 weeks of treatment in non-elderly subjects included: accidental injury, headache, infection, viral infection, dry mouth, dyspepsia, nausea, vomiting, abnormal dreams, anxiety, depression, dizziness, hallucinations, decreased libido, nervousness, somnolence, rash, unpleasant taste.

Next Day Residual Effects:
LUNESTA 3 mg was associated with next-morning psychomotor and memory impairment that was most severe at 7.5 hours, but still present and potentially clinically meaningful at 11.5 hours. Subjective perception of sedation and coordination from LUNESTA 3 mg was not consistently different from placebo, even though subjects were objectively impaired.

Withdrawal Events:
With nightly administration of LUNESTA 3 mg, rates of anxiety reported as an adverse event were 3.7% vs. 2.1% for placebo.

Recommended Dose:
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. The total dose of LUNESTA should not exceed 3 mg, once daily immediately before bedtime.
In elderly or debilitated patients, the total dose of LUNESTA should not exceed 2 mg.

Dosing Considerations:

  • 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.

For More Information:
Please consult the Product Monograph at www.sunovion.ca/monographs/lunesta.pdf for important information relating to adverse reactions, drug interactions, and dosing information. The Product Monograph is also available at https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html or by calling 1-866-260-6291.

To report an adverse event, please call 1-866-234-2345.