Important Safety Information

Indications and Clinical Use:

Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient.

LUNESTA (eszopiclone) is indicated for the short-term treatment and symptomatic relief of insomnia including difficulty falling asleep, nocturnal awakenings or early morning awakenings. 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 should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply.

The use of hypnotics should be restricted for insomnia 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.

Pediatrics (<18 years of age): Safety and efficacy of eszopiclone in children below the age of 18 have not been established.

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:

COMPLEX SLEEP-RELATED BEHAVIOURS: Complex sleep-related behaviours including sleep-walking, sleep-driving, and engaging in other potentially dangerous activities while not fully awake may occur following use with LUNESTA. Some of these events may result in serious injuries, including death to self or others. Patients usually do not remember these events. Although complex sleep-related behaviours may occur with LUNESTA alone at therapeutic doses, the use of alcohol and other CNS-depressants with LUNESTA appears to increase the risk of such behaviours, as does the use of LUNESTA at doses exceeding the maximum recommended dose. Discontinue LUNESTA immediately if a patient experiences a complex sleep-related behaviour.

  • LUNESTA is not to be taken with alcohol
  • Caution is needed with concomitant use of other CNS-depressants
  • The use of LUNESTA in patients with other disorders known to affect sleep and induce frequent awakenings (e.g. sleep apnea, Periodic Limb Movement Disorder, Restless Legs Syndrome) is discouraged, as they may be also at increased risk of complex sleep-related behaviours
  • Continuous use of LUNESTA is limited to a short duration
  • Patients should be instructed not to exceed the recommended dose
  • Caution should be exercised with concomitant use of potent CYP3A4 inhibitors

RISKS FROM CONCOMITANT USE WITH OPIOIDS AND BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of LUNESTA with opioids, benzodiazepines, or other CNS depressants may result in profound sedation, respiratory depression, coma, and death.

  • The failure of insomnia to remit after 7 to 10 days may indicate the presence of primary psychiatric and/or medical illness that should be evaluated.
  • CNS depressant effects and next-day impairment: 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 after ingesting the drug.
  • Patient counseling information regarding next-day impairment: Tell patients:
    • LUNESTA may cause next-day impairment and this risk is increased if dosing instructions are not carefully followed.
    • Not to drive a car or engage in hazardous activities requiring complete alertness until they experience how the drug affects them the next day.
    • If they took LUNESTA as instructed and do not feel drowsy in the morning, they still have to wait for at least 12 hours after dosing before driving or engaging in other activities requiring full mental alertness.

Other Relevant Warnings and Precautions:

  • Increased risk of misuse, abuse, and addiction in patients with a history of addiction to, or abuse of, drugs or alcohol
  • Possibility of development of physical and psychological dependence
  • Possibility of development of tolerance
  • Possibility of rebound insomnia
  • 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.

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 www.healthcanada.gc.ca or by calling 1-866-260-6291.

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