Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
[November 19, 2014]
Health Canada has issued information concerning the use of imovane (zopiclone). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Alcohol use: The use of zopiclone after consuming alcohol increases the risk of severe side effects such as breathing difficulty and performing activities while not being aware or awake. Alcohol should not be consumed if you are taking zopiclone.
Anxiety or restlessness: An increase in daytime anxiety or restlessness has been observed during treatment with zopiclone.
Bad taste in mouth: Zopiclone may cause you to have a coated tongue, bad breath, or a bitter taste in your mouth. These effects often occur when this medication is being used.
Behaviour changes: This medication may worsen symptoms of depression, including thoughts of suicide or wanting to harm others. It may also cause agitated or aggressive behaviour. If you experience these symptoms or any other behaviour change while taking this medication, contact your doctor immediately.
Family members or caregivers of people who are taking this medication should contact the person's doctor immediately if they notice unusual behaviour changes.
Confusion: This medication affects mental efficiency (e.g., concentration, attention, and vigilance). The risk of confusion is greater for seniors and those with brain damage.
Drowsiness/reduced alertness: Zopiclone can cause excessive drowsiness and decreased mental alertness. Do not operate heavy machinery or drive after taking this medication. Wait at least 12 hours after taking this medication before driving or engaging in other activities that require mental alertness.
Medical conditions: If you have depression, breathing problems, or liver impairment, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Memory disturbance: Amnesia of varying severity has been reported following normal doses of medications like zopiclone. This effect is rare with zopiclone.
Performing activities while not fully awake: People taking zopiclone may perform activities such as sleepwalking, driving, preparing and eating food, and making phone calls while not fully awake and unaware of their actions. The next morning, they may not remember what happened. This may be more likely to occur if you use alcohol or other sedative medications. If you discover this has happened to you, contact your doctor immediately.
Withdrawal: Zopiclone can become habit-forming. Withdrawal symptoms similar to those occurring with related substances, including alcohol, have been observed after stopping the medication suddenly (after having taken it regularly over a period of time). These symptoms include:
- abdominal cramps
- extreme anxiety
- memory impairment
- muscle pain
- sleep problems such as rebound insomnia
Pregnancy: The safety of using this medication during pregnancy has not been established. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking zopiclone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of zopiclone have not been established for use by children and adolescents under 18 years of age.
Seniors: People over 65 years of age are more likely to experience dose-related side effects of zopiclone, such as drowsiness, dizziness, or impaired coordination. Using doses that are too high may result in accidents such as falls. Talk to your doctor if you are a senior and are experiencing any of the above side effects.