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Zopiclone by Sivem Pharmaceuticals ULC
How does this medication work? What will it do for me?
Zopiclone belongs to the class of medications called sedative-hypnotics. It is used for the short-term and symptomatic relief of sleep disturbances. Zopiclone can help with difficulty falling asleep, frequent wake-ups during the night, or early morning awakenings. Zopiclone should usually not be taken for more than 7 to 10 consecutive days. It should be used only by people for whom disturbed sleep results in problems functioning during the day.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white, round, biconvex, film-coated tablet embossed "213C" on one side and "TEC" on the other side, contains 5 mg of zopiclone. Nonmedicinal ingredients: calcium phosphate dihydrate, corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, maltodextrin, polydextrose, polyethylene glycol, sodium croscarmellose, titanium dioxide, and triacetin.
Each oval, film-coated, blue tablet marked with "TEC213" on one side and a score line on the other side, contains 7.5 mg of zopiclone. Nonmedicinal ingredients: calcium phosphate dihydrate, corn starch, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, hydroxypropyl methylcellulose, lactose, magnesium stearate, maltodextrin, polydextrose, polyethylene glycol, sodium croscarmellose, titanium dioxide, and triacetin.
How should I use this medication?
The usual starting dose is 3.75 mg taken just before bedtime when required to help with difficulty sleeping. The recommended adult dose of zopiclone ranges from 3.75 mg to 7.5 mg. The maximum daily dose is 5 mg for seniors, people with reduced liver or kidney function, and people taking certain medications. This medication may be habit-forming and should be taken exactly as prescribed by your doctor. You should not typically use zopiclone for more than 7 to 10 days in a row.
If you have been taking this medication regularly for an extended period of time, do not stop taking it suddenly without talking with your doctor.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. Do not take this medication when a full night’s sleep is not possible or before you would need to be active and functional. Impaired judgment and memory lapses may occur in such situations. Your body needs time to eliminate the medication from your system. Wait at least 12 hours after taking this medication before driving or engaging in other activities that require mental alertness.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to zopiclone or any ingredients of this medication
- have myasthenia gravis
- have severe breathing difficulties
- have severe liver disease
- have sleep apnea
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- agitation (more common for seniors)
- bitter taste in mouth
- dry mouth
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- behaviour changes (e.g., excitement, hyperactivity, violent behavior)
- clumsiness or unsteadiness (more common for seniors)
- confusion (more common for seniors)
- daytime anxiety or restlessness
- difficult or laboured breathing
- difficulty with coordination (more common for seniors)
- drowsiness (severe)
- memory problems (more common for seniors)
- shortness of breath
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- withdrawal effects (e.g., abdominal cramps, vomiting, sweating, tremor, seizures)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- thoughts of self-harm or suicide
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
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
October 30, 2020
Health Canada has issued new restrictions concerning the use of benzodiazepines and benzodiazepine-like prescription drugs. 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.
Breathing: Sedatives can suppress breathing. If you have asthma, or other lung disease that increases your risk for breathing difficulties, such as sleep apnea, 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.
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.
Depression: Sedative medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression or suicidal thoughts, 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. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.
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.
Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have kidney problems, you may require lower doses of this medication.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, you may require lower doses of this medication.
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.
What other drugs could interact with this medication?
There may be an interaction between zopiclone and any of the following:
- anti-anxiety medications (e.g., alprazolam, clonazepam, lorazepam)
- anticonvulsants (medications used to prevent seizures; e.g., phenytoin, valproic acid, carbamazepine, gabapentin)
- antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotic medications (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- "azole" antifungals (e.g., ketoconazole, itraconazole, voriconazole)
- barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- chloral hydrate
- general anesthetics (medications used to put you to sleep for surgery)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., darunavir, ritonavir, saquinavir)
- kava kava
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine, tizanidine)
- narcotic or opioid medications (e.g., codeine, fentanyl, morphine, oxycodone)
- St. John’s wort
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- tricyclic antidepressants (e.g., amitriptyline, desipramine)
- tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Zopiclone-by-Sivem-Pharmaceuticals-ULC