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Details for: MINT-ZOPICLONE

Company: MINT PHARMACEUTICALS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02391716MINT-ZOPICLONEZOPICLONE5 MGTABLETORAL
02391724MINT-ZOPICLONEZOPICLONE7.5 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

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

What it does

MINT-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 andPrecautions)

When it should not be used

Do not use MINT-ZOPICLONEif 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 zopicloneor any of the ingredients MINT-ZOPICLONEcontains (see Whatthe nonmedicinal ingredients are).
  • ever experienced complex sleep behaviours including sleep-walking or other unusual behaviour (such as driving, eating, making a phone call or having sex) while not being fully awake after taking MINTZOPICLONE or any other medication to help you sleep.
What the medicinal ingredient is

Zopiclone

What the non-medicinal ingredients are

MINT-ZOPICLONE 5 mg contains: Dibasic Calcium Phosphate, Croscaramellose Sodium, Microcrystalline Cellulose, Povidone K-30, Magnesium Stearate, Opadry II white (Polyvinyl Alcohol, Titanium Dioxide, Polyethylene glycol, and Talc).

MINT-ZOPICLONE 7.5 mg contains: Dibasic Calcium Phosphate, Croscaramellose Sodium, Microcrystalline Cellulose, Povidone K-30, Magnesium Stearate, Opadry II blue (Polyvinyl Alcohol, Titanium Dioxide, Polyethylene glycol, Talc, and FD&C Blue #1/Brilliant blue FCF Aluminum lake).

What dosage form it comes in

Tablets, 5mg and 7.5 mg

Warnings and precautions

Serious Warnings and Precautions

Taking MINT-ZO PICLO NE with opioids:
Taking MINT-ZO PICLO NE 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 MINT-ZO PICLO NE. These behaviours may result in serious injuries, including death. Stop using MINT-ZO PICLO NE immediately if you experience any complex sleep behaviours.

Complex sleepbehaviours
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 doingthose activities. The activities youmay do in these situations can put you and people aroundyouin danger and can cause serious injuries or death.Reported activities ncluded driving a car (“sleep-driving”), leavingthe 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 MINT-ZOPICLONE. If you experience any of the above, stop taking MINTZOPICLONE immediately and contact your doctor or healthcare professional.

Important:

  1. Do not take more MINT-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 MINT-ZOPICLONEif 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 allof yourmedicines, including over-the-countermedicines and herbal products.Your doctor will tell you if you can take MINT-ZOPICLONEwith your other medicines.
  7. You and people close to you should watch for the complex sleep behaviours describedabove. If you find out that you havedone any such activities forwhich you haveno memory you should callyour doctor immediately.

Mental Alertness:
MINT-ZOPICLONEmay 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: MINT-ZOPICLONE may cause a special typeof memory loss (amnesia); you may not recall eventsthat occurred duringsome period oftime, usually severalhours, after taking the drug.This lapse is usually not a problem, becausethe person taking the sleeping pill intends to be asleep during this critical period of time. But it can be a problemif you take the medication to induce sleep while travelling,suchas during an airplane flight, becauseyou may wake up before the effect of the drug is gone. This has been called “traveller’s amnesia”.DO NOT TAKE MINTZOPICLONE when a full night's sleep is notpossible before you would again need to beactive and functional; e.g., an overnight flight of less than 8hours.Memory lapses may occurin 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 effectivenessand you may also develop a degree of dependence.

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

You may also experience “withdrawal effects” when you stop the medication aftertaking it for only a week or two.But usually, these withdrawal effects are more common and severe afterlong periods of continuous use. For instance, on thefirst few nights afterstopping the medication, you may find that insomnia is worse than before takingthe sleeping pills.This typeof withdrawal symptomis known as “rebound insomnia”.

Otherwithdrawal effectsfollowing abrupt stopping of sleeping pills may range fromunpleasant 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 fewweeks, or at higher doses.Some people develop a needto continue taking these drugs, not only for continuedtherapeutic effect, but also to avoid withdrawal symptoms or to achievenon-therapeutic effects.

Individuals who depend, or have dependedat any time in the past, on alcoholor other drugsmay be at particularrisk of becoming dependenton drugs of this class. But all people are at some risk. Consider this matter before you take these medications beyond the recommended 7-10 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 thinkingand behavioural changesmay occurwhen you useprescription sleeping pills. Some of these changesinclude aggressiveness andextroversion which seemout 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 clearwhethersuch symptoms are causedby the medication, or by an illness that was present before the medication was used, or are simply spontaneous happenings.If you developany unusual disturbing thoughts or behaviour while using MINTZOPICLONE, discussthe matterimmediately with your doctor.

Worsening ofSide Effects:
DO NOT CONSUME ALCOHOL WHILE TAKING MINT-ZOPICLONE. Some medicines may also worsen side effects that some patients experience with zopiclone (see Interactions with this medication).
Elderly: An increased risk offalls 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 duringthe early months of pregnancy.It is not yet known if MINT-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 MINT-ZOPICLONE at anytime during pregnancy,it may affect the developing baby.

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

BEFORE you use MINT-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 MINTZOPICLONE 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 historyof depressionand/orsuicide thoughts or attempts.
  • have had unexpected reactionsto 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 pregnantwhile taking this medication.
  • are breastfeeding.
  • consume alcohol.
  • are taking opioid medicines or other central nervous system depressants such as sedative or hypnotics (see NTERACTIONS WITH THIS MEDICATIONS), as well as if you are taking any othermedicines, including over-the- counter medicines and herbalproducts.
Interactions with this medication

Do not use MINT-ZOPICLONEif you drinkalcohol. Do not use MINT-ZOPICLONE along with other medications, over-thecounter medicines or herbal products without first discussingthis with your doctor or pharmacist.
MINT-ZOPICLONE may producemore pronounced side effects when co-administered with:

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

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

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

MINT-ZOPICLONE is an effective medicationand is relatively free of serious problems when used forthe short-termmanagement 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:

MINT-ZOPICLONE should be taken at bedtime just before retiring forthe 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 3.75mg (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 howto take MINTZOPICLONE, when to take it, and how long to take it.

The lowest effective dose shouldbe used.

Do not increase the prescribed dose of MINTZOPICLONE.

Do not take MINT-ZOPICLONEif it is not prescribed for you.

Treatment with MINT-ZOPICLONEshould usually not exceed 7-10 consecutive days. Do not take MINTZOPICLONE formore than 7-10 days without first consultingyour doctor. If you still have problems sleeping after you finish yourtablets, contact your doctor again.

Do not take MINT-ZOPICLONE if you drink alcohol. MINT-ZOPICLONE is not indicated for patients under 18 years of age.Do not take MINT-ZOPICLONE if you are under 18 years of age. Do not take MINT-ZOPICLONE when a full night’s sleep is not possible beforeyou would again needto be active and functional. Do not drive a car or operate potentially dangerous machinery until you experience how this drugwill affect you the next day (see WARNINGS AND PRECAUTIONS, Mental Alertness).

Overdose:

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

Missed Dose

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

Side effects and what to do about them

Common Side Effects:
The most common adverse reactionseen with zopiclone is taste alteration (bitter taste).

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

Howsleepy youare the day after you use MINTZOPICLONE depends onyour individual response and on how quickly your bodygets rid ofthe 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.

MINT-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 and death.

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

Withdrawal-related sideeffects: You may experience an increase in sleep difficulties (reboundinsomnia) and/or “increased daytime anxiety” (reboundanxiety) for one ortwo days after discontinuing MINTZOPICLONE (see Warnings andPrecautions, 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 MINT-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    

How to store

Store in a dry place, at room temperature (15ºC30ºC). Protect from light. Do not exceed the expiry date indicated on the container. Keep in a safe place out of reach and sightof 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 MINTZOPICLONE:

This leaflet was prepared by:
Mint Pharmaceuticals Inc.
6575 Davand Drive Mississauga, Ontario
Canada L5T 2M3
Last Revised: July 30, 2021

Date modified: