Imovane

The usual starting dose is 3.75 mg taken just before bedtime when required to help with difficulty sleeping. The recommended adult dose of Imovane (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. Imovane (Zopiclone) may be habit-forming and should be taken exactly as prescribed by your doctor. You should not typically use Imovane (Zopiclone) for more than 7 to 10 days in a row.

If you have been taking Imovane (Zopiclone) 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 Imovane (Zopiclone) exactly as prescribed by your doctor. Do not take Imovane (Zopiclone) 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 Imovane (Zopiclone) before driving or engaging in other activities that require mental alertness.

Store Imovane (Zopiclone) 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause a bitter aftertaste; it may cause dryness of the mouth; it may cause unusual tiredness; it may cause drowsiness that lasts until the next day - use caution until you know how you will react. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

5 mg
Each round, white tablet, marked "IMOVANE 5" on one side and the logo "rPr" on the other, contains 5 mg of Imovane (Zopiclone). Nonmedicinal ingredients: corn starch, dicalcium phosphate, lactose, magnesium stearate, and sodium carboxymethyl starch; coating: hydroxypropyl methylcellulose and titanium dioxide.

7.5 mg
Each oval, scored, blue tablet, marked "IMOVANE" on one side and the logo "rPr" on each side of the score on the other side, contains 7.5 mg of Imovane (Zopiclone). The 7.5 mg tablet can be broken into two equal parts of 3.75 mg. Nonmedicinal ingredients: calcium phosphate dihydrate dibasic, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose; coating: carnauba wax, FD&C Blue No. 1 Aluminum Lake, opadry II White 2, and polyethylene glycol.

Do not take Imovane (Zopiclone) if you:

• are allergic to Imovane (Zopiclone) or any ingredients of Imovane (Zopiclone)
• have Myasthenia Gravis
• have severe breathing difficulties
• have severe liver disease
• have Sleep Apnea

There may be an interaction between Imovane (Zopiclone) and any of the following:

• alcohol
• Amiodarone
• 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)
• Aprepitant
• azelastine
• "azole" antifungals (e.g., ketoconazole, itraconazole, Voriconazole)
• barbiturates (e.g., butalbital, pentobarbital, Phenobarbital)
• Bosentan
• brimonidine
• Buspirone
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• cannabis
• chloral hydrate
• Clonidine
• Cobicistat
• conivaptan
• Dapsone
• Deferasirox
• Dronedarone
• Enzalutamide
• 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
• lithium
• Lomitapide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• melatonin
• Methadone
• e
• mifepristone
• Mirtazapine
• Mitotane
• Modafinil
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine, Tizanidine)
• Nabilone
• narcotic or opioid medications (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nefazodone
• npramipexole
• rifabutin
• rifampin
• Ropinirole
• Rotigotine
• St. John's wort
• scopolamine
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• siltuximab
• suvorexant
• Tapentadol
• Tetrabenazine
• thalidomide
• Tocilizumab
• tolcapone
• Tramadol
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine)
• tyrosine kinase inhibitors (e.g., Dasatinib, imatinib, Nilotinib, Sunitinib)
• Zolpidem

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 Imovane (Zopiclone). 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.

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 Imovane (Zopiclone).

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 Imovane (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 Imovane (Zopiclone).

Anxiety or restlessness: An increase in daytime anxiety or restlessness has been observed during treatment with Imovane (Zopiclone).

Bad taste in mouth: Imovane (Zopiclone) may cause you to have a coated tongue, bad breath, or a bitter taste in your mouth. These effects often occur when Imovane (Zopiclone) is being used.

Behaviour changes: Imovane (Zopiclone) 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 Imovane (Zopiclone), contact your doctor immediately.

Family members or caregivers of people who are taking Imovane (Zopiclone) 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 Imovane (Zopiclone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Imovane (Zopiclone), and whether any special monitoring is needed.

Confusion: Imovane (Zopiclone) 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 Imovane (Zopiclone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Imovane (Zopiclone), 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 Imovane (Zopiclone) contact your doctor as soon as possible.

Drowsiness/reduced alertness: Imovane (Zopiclone) can cause excessive drowsiness and decreased mental alertness. Do not operate heavy machinery or drive after taking Imovane (Zopiclone). Wait at least 12 hours after taking Imovane (Zopiclone) before driving or engaging in other activities that require mental alertness.

Kidney function: Kidney Disease or reduced kidney function may cause Imovane (Zopiclone) to build up in the body, causing side effects. If you have kidney problems, you may require lower doses of Imovane (Zopiclone).

Liver function: Liver disease or reduced liver function may cause Imovane (Zopiclone) to build up in the body, causing side effects. If you have liver problems, you may require lower doses of Imovane (Zopiclone).

Memory disturbance: Amnesia of varying severity has been reported following normal doses of medications like Imovane (Zopiclone). This effect is rare with Imovane (Zopiclone).

Performing activities while not fully awake: People taking Imovane (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: Imovane (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
• agitation
• confusion
• Diarrhea
• extreme anxiety
• headache
• irritability
• memory impairment
• muscle pain
• nervousness
• restlessness
• sleep problems such as rebound Insomnia
• tension
• tremors
• vomiting

Pregnancy: The safety of using Imovane (Zopiclone) during pregnancy has not been established. Imovane (Zopiclone) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Imovane (Zopiclone), contact your doctor immediately.

Breast-feeding: Imovane (Zopiclone) passes into breast milk. If you are a breast-feeding mother and are taking Imovane (Zopiclone), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Imovane (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 Imovane (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.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Generally, it is used only as needed. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. You must wait at least 12 hours after taking this drug before driving or engaging in other activities requiring full mental alertness. This medication may be taken with or without food. Consuming alcohol may intensify the effect of this product. It is therefore advisable to avoid consuming alcohol or alcohol-containing products while taking this medication.