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Details for: ZOPICLONE

Company: SIVEM PHARMACEUTICALS ULC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02385821ZOPICLONEZOPICLONE5 MGTABLETORAL
02385848ZOPICLONEZOPICLONE7.5 MGTABLETORAL
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Summary Reports

Summary Safety Review - IMOVANE (zopiclone) - Next-Day Impairment

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

ZOPICLONE is a prescription medication intended to help you sleep if you are over 18 years of age and have transient and short-term insomnia. Symptoms of insomnia may vary: you may have difficulty in falling asleep, or awaken often during the night, or awaken early in the morning, or you may have all three symptoms.

Treatment with ZOPICLONE should usually not go on for more than 7 to 10 days and should be restricted for insomnia where disturbed sleep results in impaired daytime functioning. ZOPICLONE does not treat the underlying cause of your insomnia.

What it does

ZOPICLONE is one of several prescription sleeping pills that have generally similar properties such as a calming effect.

If you are prescribed sleep medications, you should consider both their benefits and risks. Important risks and limitations include the following:

  • you may become dependent on the medication,
  • the medication may affect your mental alertness or memory, particularly when not taken as prescribed. (see Warnings and Precautions)
When it should not be used

Do not use ZOPICLONE if you have:

  • a muscular disease known as myasthenia gravis
  • a severe hepatic insufficiency (liver problems)
  • severe lung or respiratory disease, including sleep apnea.
  • a known allergy to zopiclone or any of the ingredients ZOPICLONE contains (see What the nonmedicinal ingredients are).
  • ever experienced complex sleep behaviours including sleepwalking or other unusual behaviour (such as driving, eating, making a phone call or having sex) while not being fully awake after taking ZOPICLONE or any other medication to help you sleep.
What the medicinal ingredient is

The active ingredient in ZOPICLONE is zopiclone

What the non-medicinal ingredients are

The non-medicinal ingredients of ZOPICLONE 5 mg are carnauba wax, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

The non-medicinal ingredients of Zopiclone 7.5 mg are carnauba wax, D&C yellow #10, FD&C blue #1, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

What dosage form it comes in

ZOPICLONE is available in 5 mg and 7.5 mg tablets for oral administration.

Warnings and precautions

Serious Warnings and Precautions

Taking ZOPICLONE with opiods:

  • Taking ZOPICLONE with opioid medicines can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Complex Sleep Behaviours:

  • Complex sleep behaviours, including sleepwalking, sleep-driving and doing other activities while you are not fully awake, can happen after taking medications to help you sleep, including ZOPICLONE. These behaviours may result in serious injuries, including death. Stop using ZOPICLONE immediately if you experience any complex sleep behaviours.

Complex sleep behaviours:

There have been reports of people getting out of bed while not fully awake after taking ZOPICLONE and doing activities that they did not know they were doing. The next morning, they did not remember doing those activities. The activities you may do in these situations can put you and people around you in danger and can cause serious injuries or death. Reported activities included driving a car (“sleepdriving”), leaving the house, making and eating food, talking on the phone, having sex etc. These activities may occur whether or not you drink alcohol or take other medicines that make you drowsy with ZOPICLONE. If you experience any of the above, stop taking ZOPICLONE immediately and contact your doctor or healthcare professional.

Important:

  1. Do not take more ZOPICLONE than prescribed.
  2. Do not use for longer than recommended by your physician. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
  3. Do not take ZOPICLONE if you drink alcohol.
  4. Talk to your doctor if you have had episodes of sleepwalking in the past, or if there is a history of sleepwalking in your family.
  5. Talk to your doctor if you have a condition that affects your sleep, such as Periodic Limb Movement Disorder (involuntary movement of limbs during sleep) or Restless Legs Syndrome (urge to move legs, usually accompanied by uncomfortable and unpleasant sensations, that begins or worsens during periods of inactivity, typically in the evening and night).
  6. Talk to your doctor about all of your medicines, including overthe-counter medicines and herbal products. Your doctor will tell you if you can take ZOPICLONE with your other medicines.
  7. You and people close to you should watch for the complex sleep behaviours described above. If you find out that you have done any such activities for which you have no memory you should call your doctor immediately.

Mental Alertness: ZOPICLONE may affect your ability to be alert next day. DO NOT DRIVE A CAR or operate potentially dangerous machinery:

  • If you do not feel fully awake
  • If it has not been at least 12 hours since taking the medicine, even if you feel fully awake, especially in elderly patients and in patients who take the 7.5 mg dose
  • In all cases, until you experience how the drug affects you next day
Memory problems: ZOPICLONE may cause a special type of memory loss (amnesia); you may not recall events that occurred during some period of time, usually several hours, after taking the drug. This lapse is usually not a problem, because the person taking the sleeping pill intends to be asleep during this critical period of time. But it can be a problem if you take the medication to induce sleep while travelling, such as during an airplane flight, because you may wake up before the effect of the drug is gone. This has been called “traveller’s amnesia”. DO NOT TAKE ZOPICLONE when a full night's sleep is not possible before you would again need to be active and functional; e.g., an overnight flight of less than 8 hours. Memory lapses may occur in such situations. Your body needs time to eliminate the medication from your system.

Tolerance/Withdrawal Symptoms: After nightly use, sleeping pills may lose some of their effectiveness and you may also develop a degree of dependence.

When taking ZOPICLONE, you may get awakened during the last third of the night or feel anxious or nervous during the day. If this occurs, tell your doctor.

You may also experience “withdrawal effects” when you stop the medication after taking it for only a week or two. But usually, these withdrawal effects are more common and severe after long periods of continuous use. For instance, on the first few nights after stopping the medication, you may find that insomnia is worse than before taking the sleeping pills. This type of withdrawal symptom is known as “rebound insomnia”.

Other withdrawal effects following abrupt stopping of sleeping pills may range from unpleasant feelings to a major withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremor, and rarely, convulsions. The severe symptoms are uncommon. If you have been taking sleeping pills for a long time, discuss with your physician when and how it would be best for you to stop.

Dependence/Abuse: All prescription sleeping pills can cause dependence (addiction) especially when used regularly for more than a few weeks, or at higher doses. Some people develop a need to continue taking these drugs, not only for continued therapeutic effect, but also to avoid withdrawal symptoms or to achieve non-therapeutic effects.

Individuals who depend, or have depended at any time in the past, on alcohol or other drugs may be at particular risk of becoming dependent on drugs of this class. But all people are at some risk. Consider this matter before you take these medications beyond the recommended 7 to 10 days, because longer treatment times increase the risk of dependence. The risk of dependence is also greater in patients with a history of mental health problems and/or alcohol or drug abuse.

Mental and Behavioural Changes: A variety of abnormal thinking and behavioural changes may occur when you use prescription sleeping pills. Some of these changes include aggressiveness and extroversion which seem out of character. Other changes, although rare, can be more unusual and extreme. These include confusion, strange behaviour, restlessness, agitation, irritability, nightmares, hallucinations, delusion (a false belief or wrong judgment, held with conviction despite evidence to the contrary), feeling like you are not yourself, and feeling more depressed, which may lead to suicidal thinking.

It is rarely clear whether such symptoms are caused by the medication, or by an illness that was present before the medication was used, or are simply spontaneous happenings. If you develop any unusual disturbing thoughts or behaviour while using ZOPICLONE, discuss the matter immediately with your doctor.

Worsening of Side Effects: DO NOT CONSUME ALCOHOL WHILE TAKING ZOPICLONE. Some medicines may also worsen side effects that some patients experience with ZOPICLONE (see Interactions with this medication). Elderly: An increased risk of falls and fractures has been reported in elderly people who take sleeping pills such as ZOPICLONE.

Effects on Pregnancy: Certain sleeping pills have been linked to birth defects when taken during the early months of pregnancy. It is not yet known if ZOPICLONE could cause similar effects. In addition, sleeping pills taken during the last weeks of pregnancy have been known to sedate the baby and may also cause withdrawal symptoms after birth. Therefore, DO NOT TAKE ZOPICLONE at anytime during pregnancy, it may affect the developing baby.

Use in Nursing Mothers: ZOPICLONE passes into breast milk. Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you.

BEFORE you use ZOPICLONE talk to your doctor or pharmacist if you:
  • have a lung disease or breathing problems.
  • have liver or kidney condition.
  • have ever had mental health problems or have abused or been dependent on alcohol or drugs. The risk of dependence is greater when ZOPICLONE is used for longer than 4 weeks, and in patients with a history of mental health problems and/or alcohol or drug abuse.
  • have a history of depression and/or suicide thoughts or attempts.
  • have had unexpected reactions to alcohol or sedative medications in the past, such as irritability, aggression, hallucinations, etc.
  • are planning to become pregnant, if you are pregnant, or if you become pregnant while taking this medication.
  • are breastfeeding.
  • consume alcohol.
  • are taking opioid medicines or other central nervous system depressants such as sedative or hypnotics (see INTERACTIONS WITH THIS MEDICATION), as well as if you are taking any other medicines, including over-the counter medicines and herbal products.
  • have lactose intolerance.
Interactions with this medication

Do not use ZOPICLONE if you drink alcohol. Do not use ZOPICLONE along with other medications, over-the counter medicines or herbal products without first discussing this with your doctor or pharmacist.

ZOPICLONE may produce more pronounced side effects when coadministered with:

  • Alcohol
  • Other tranquilizers or sleeping pills
  • Sedative antihistamines
  • Anticonvulsants (medicines used to control or prevent convulsions)
  • Narcotic analgesics (opioids) (see Serious Warnings and Precautions box)
  • Antipsychotics, antidepressants and other psychotropic medications (mood altering drugs) which themselves can make you sleepy.

Other drugs which may interact with ZOPICLONE by affecting the way the drug is metabolized by the enzyme CYP3A4 in the liver include:

  • CYP3A4 inhibitors, such as erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir;
  • CYP3A4 inducers, such as rifampicin or rifampin, carbamazepine, phenobarbital, phenytoin, and St. John’s wort.
Proper use of this medication

ZOPICLONE is an effective medication and is relatively free of serious problems when used for the short-term management of insomnia. Sleeplessness may last only for a short time and may respond to brief treatment. The risks and benefits of prolonged use should be discussed with your doctor.

Usual Dose:

ZOPICLONE should be taken at bedtime just before retiring for the night.

Adults: The recommended starting dose is 3.75 mg (one half of a 7.5 mg tablet). This can be increased to 5 mg or 7.5 mg if advised by your doctor.

Special population: Elderly (65 years of age or more), debilitated patients and/or patients with liver, kidney, or chronic respiratory problems should start with 3.75 mg (one-half of a 7.5 mg tablet) at bedtime just before retiring. The dose in elderly, debilitated patients and/or patients with liver or kidney problems is not to exceed 5 mg.

Follow your doctor’s advice about how to take ZOPICLONE, when to take it, and how long to take it.

The lowest effective dose should be used.

Do not increase the prescribed dose of ZOPICLONE. Do not take ZOPICLONE if it is not prescribed for you.

Treatment with ZOPICLONE should usually not exceed 7 to 10 consecutive days. Do not take ZOPICLONE for more than 7 to 10 days without first consulting your doctor. If you still have problems sleeping after you finish your tablets, contact your doctor again.

Do not take ZOPICLONE if you drink alcohol.

ZOPICLONE is not indicated for patients under 18 years of age. Do not take ZOPICLONE if you are under 18 years of age.

Do not take ZOPICLONE when a full night’s sleep is not possible before you would again need to be active and functional.

Do not drive a car or operate potentially dangerous machinery until you experience how this drug will affect you the next day (see WARNINGS AND PRECAUTIONS, Mental Alertness).

Overdose:

If you think you have taken too much ZOPICLONE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

ZOPICLONE should be taken at bedtime just before retiring for the night. If you miss a dose, wait and take your next dose at your regular time. Do not take 2 doses at the same time. Do not make up for a missed dose

Side effects and what to do about them

Common Side Effects: The most common adverse reaction seen with ZOPICLONE is taste alteration (bitter taste).

ZOPICLONE may cause drowsiness, dizziness, lightheadedness, and difficulty with coordination. Users must be cautious about engaging in hazardous activities requiring complete mental alertness, e.g., operating machinery or driving a motor vehicle. This risk is increased by concomitant intake of alcohol.

How sleepy you are the day after you use ZOPICLONE depends on your individual response and on how quickly your body gets rid of the medication. The larger the dose, the more likely that you will experience drowsiness, etc., the next day. It is important that you comply with the dose your physician has prescribed. If you experience excessive drowsiness the next day that affects your ability to perform tasks in the morning contact your physician as your dose may need to be reduced (see Warnings and Precautions, Mental Alertness).

Elderly patients are especially susceptible to side effects. Excessive drowsiness in the elderly may result in falls and fractures.

ZOPICLONE may cause sleep walking or other unusual behaviour (such as driving, eating, making a phone call, or having sex) while not being fully awake, some of which have been associated with serious injuries or death.

Do not drink alcohol while using ZOPICLONE. Do not use sleeping pills along with other medications without first discussing this with your doctor.

Withdrawal-related side effects: You may experience an increase in sleep difficulties (rebound insomnia) and/or “increased daytime anxiety” (rebound anxiety) for one or two days after discontinuing ZOPICLONE (see Warnings and Precautions, Tolerance/Withdrawal Symptoms).

Allergic reactions: Rare cases of severe allergic reactions have been reported. Symptoms may include:

  • swelling of the tongue or throat, trouble breathing, nausea and vomiting. Get emergency medical help if you get these symptoms after taking ZOPICLONE.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Uncommon
Unexpected reactions such as excitement, agitation, hyperactivity, hallucination, worsened insomnia, aggression, irritability, rages, psychoses, and violent behaviour    
Depressed Mood    
Severe allergic reactions (swelling of the tongue or throat, trouble breathing, nausea and vomiting)    
Withdrawal effects (abdominal and muscle cramps, vomiting, sweating, tremor, and very rare cases of, convulsions)    
Rare
Complex sleep behaviours (sleep walking, sleep driving, eating, making phone calls, having sex)    
Very Rare
thoughts of death or suicide    
Unknown
Trouble breathing    

This is not a complete list of side effects. For any unexpected effects while taking ZOPICLONE, contact your doctor or pharmacist.

How to store

Store in a dry place at room temperature (15ºC to 30ºC). Protect from light. Do not exceed the expiry date indicated on the container.

Keep in a safe place out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about ZOPICLONE:

This leaflet was prepared by
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7

Date of revision: October 4, 2021

Date modified: