Mar-Eszopiclone: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is MAR-ESZOPICLONE used for?

MAR-ESZOPICLONE is used in adults for short term (usually not more than 7 – 10 days) treatment of insomnia. This is a sleep disorder that makes it hard to fall asleep, hard to stay asleep, or causes you to wake up too early. MAR-ESZOPICLONE should only be used when the effects of insomnia affect your daytime activities.

If you are 65 years or older, talk to your healthcare professional before starting MAR-ESZOPICLONE. MAR-ESZOPICLONE may not be an effective treatment for you and you may be more sensitive to experiencing side effects.

How does MAR-ESZOPICLONE?

MAR-ESZOPICLONE works by increasing the activity of a chemical in your brain called gamma- aminobutyric acid (GABA). This calms the brain which helps you go to sleep.

What are the ingredients in Mar Eszopiclone?

Medicinal ingredients: eszopiclone

Non-medicinal ingredients: Croscarmellose Sodium, Hypromellose, Lactose monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Titanium Dioxide, Triacetin, FD&C Blue #2 (1 mg & 3 mg) .

MAR-ESZOPICLONE comes in the following dosage forms:

Tablets: 1 mg, 2 mg, or 3 mg

Do not use MAR-ESZOPICLONE if you:

• are allergic to eszopiclone, zopiclone or to any of the other ingredients in MAR-ESZOPICLONE or component of the container (see What are the ingredients in MAR-ESZOPICLONE?)
• have a muscle disease know as myasthenia gravis, a condition where the muscles easily tire and become weak
• have severe lung or breathing problems such as sleep apnea (sleep disorder where you stop breathing for short periods while you sleep)
• are elderly and taking certain antifungal or antibiotic medicines (i.e. ketoconazole) or you have severe liver problems
• have a past history of unexpected reactions to other sedative medications. This can include driving a car, making and eating food, talking on the phone or having sex while not being fully awake.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MAR-ESZOPICLONE. Talk about any health conditions or problems you may have, including if you:

• have signs of depression or a history of depression
• have or have a history of suicidal thoughts or attempts or mental health problems

• have ever had a problem with:

  • substance use, including prescribed or illegal drugs, or
  • alcohol
• have had an unexpected reaction to sedative medications in the past, including alcohol and benzodiazepines
• have a history of violent behaviour
• have liver or kidney problems
• have lung or breathing problems
• have a history or family history of sleepwalking
• have disorders that affect your sleep, such as Periodic Limb Movement (involuntary movement of the limbs during sleep) or Restless Legs Syndrome (urge to move legs, typically in the evening and night).
• have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness)
• drink or plan to drink alcohol. Do not drink alcohol while you take MAR-ESZOPICLONE
• are taking any other medicines, including central nervous system depressants (slow down brain activity)
• are 65 years of age or older

• are lactose intolerant or have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in MAR-ESZOPICLONE.

Other warnings you should know about:

• Complex Sleep Behaviours: MAR-ESZOPICLONE can cause dangerous sleeping-related behaviours such as getting out of bed while not fully awake and doing activities that you do not know you are doing. You may not remember doing those activities when you wake up. These unusual behaviours are more likely to happen when MAR-ESZOPICLONE is taken with alcohol or other medicines that can make you sleepy, such as medicines used to treat depression or anxiety. If you drink alcohol, do not take MAR-ESZOPICLONE. The activities you may do in these situations can put you and people around you in danger. This can include driving a car (“sleep-driving”), leaving the house, making and eating food, having sex and talking on the phone. These behaviours can cause serious injuries, including death. You and people close to you should watch out for unusual types of behaviour when you are asleep. If you find out that you have done any such activities for which you have no memory, you should stop taking MAR-ESZOPICLONE and call your healthcare professional right away.

• Driving and Using Machines: MAR-ESZOPICLONE may make you feel dizzy, drowsy and affect your coordination. DO NOT drive, use machinery, or do activities that requires you to be alert:

  • if it has not been 12 hours or more since you took MAR-ESZOPICLONE, especially if you are elderly or you take the 3 mg dose.
  • if you do not feel fully awake
  • until you know how MAR-ESZOPICLONE affects you
  • if you are also taking opioid medicine
  • if you have consumed alcohol
  • if you are taking other medications, including central nervous system (CNS) depressants (slow down brain activity)

• Memory Problems: MAR-ESZOPICLONE may cause a type of memory loss known as amnesia. This is characterized by having trouble remembering events that recently occurred, usually several hours after taking the medication. This is usually not a problem if you take MAR-ESZOPICLONE before sleeping. However, if you take MAR-ESZOPICLONE to help you sleep while travelling, such as during an airplane flight, you may wake up to a memory lapse caused by the drug. This has been called “traveller’s amnesia” and can be a problem. DO NOT take MAR-ESZOPICLONE when a full night's sleep is not possible before you need to be active and functional (e.g., an overnight flight of less than 8 hours). Your body needs time to eliminate MAR-ESZOPICLONE from your system

  Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening. Some of your withdrawal symptoms can last for months after you stop MAR-ESZOPICLONE.

  Your risk of going through withdrawal is higher if you are taking MAR-ESZOPICLONE for a long time or at high doses. However, symptoms can still occur if you are taking MAR-ESZOPICLONE as directed for a short period of time or slowly reducing the dose.

  The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).

  Tell your healthcare professional right away if you experience any symptoms of withdrawal after changing or stopping your treatment.

  Severe symptoms of withdrawal include:

  • a sudden and severe change in mental state that can cause a combination of confusion, disorientation and/or attention deficit (delirium)
  • experiences of unreality or detachment from one’s surroundings (derealisation)
  • experiences of unreality or detachment from one’s mind, self, or body (depersonalisation)
  • seeing or hearing things that are not there (hallucinations)
  • sensitivity to sounds and noise (hyperacusis)
  • convulsions (seizures), including some that do not stop

For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).

To reduce your chances of going through withdrawal:

• always contact your healthcare professional before stopping or reducing your dose of MAR-ESZOPICLONE or changing medications
• always follow your healthcare professional’s instructions on how to reduce your dose carefully and safely
• tell your healthcare professional right away if you experience any unusual symptoms after changing or stopping your treatment.

• Falls and Fractures: Benzodiazepines or other sedative-hypnotic drugs, such as MAR-ESZOPICLONE can cause you to feel sleepy, dizzy and affect your balance. This increases your risks of falling, which can cause fractures or other fall related-injuries, especially if you:

  • take other sedatives
  • consume alcohol
  • are elderly or
  • have a condition that causes weakness or frailty
• Mental and Behavioural Changes: A variety of abnormal thinking and behavioural changes may occur when you take MAR-ESZOPICLONE. Some of these changes include aggressiveness and extroversion that seem out of character, delusion (a sudden and severe change in mental state which includes a combination of confused thinking, disorientation and decreased attention), confusion, strange behaviour, anxiety, restlessness, hallucinations, feeling like you are not yourself, worsening of insomnia or depression, which may lead to suicidal thinking. If you develop any unusual thoughts or behaviour while using MAR-ESZOPICLONE, tell your healthcare professional right away.

• Self-harm or Suicide: If you have thoughts of harming or killing yourself at any time, talk to

  your healthcare professional or go to a hospital right away. You may find it helpful to tell a relative or close friend that you are depressed or have other mental illnesses. Ask them to read this leaflet. You might ask them to tell you if they:

  • think your depression or mental illness is getting worse, or
  • are worried about changes in your behaviour

• Pregnancy: Do not take MAR-ESZOPICLONE if you are pregnant. MAR-ESZOPICLONE may harm your unborn baby (e.g. birth defects) if you are pregnant. This risk is higher during the first trimester or last weeks of pregnancy. It may also cause side effects and withdrawal symptoms in your baby after birth. If you are able to get pregnant, want to be or think you are pregnant, there are specific risks you should discuss with your healthcare professional.

• Breastfeeding: MAR-ESZOPICLONE passes into breast milk. Do not breastfeed while taking MAR-ESZOPICLONE Talk to your healthcare professional about the best way to feed your baby while you are taking MAR-ESZOPICLONE.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MAR-ESZOPICLONE:

• alcohol. DO NOT take MAR-ESZOPICLONE if you drink alcohol.
• other hypnotics or sedatives that are used to help with sleeping
• sedative antihistamines that are used to treat allergies
• anticonvulsants used to prevent or treat seizures
• anesthetics, used during surgery
• medicines used to treat mental health disorders (antipsychotics and psychotropic medication)
• medicines used to treat fungal and bacterial infections such as ketoconazole, itraconazle, rifampicin, rifampin, erythromycin and clarithromycin
• ritonavir, used to treat HIV
• medicines used to treat or prevent seizures such as carbamazepine, phenytoin and phenobarbital
• St John’s wort, an herbal medicine

How to take MAR-ESZOPICLONE:

• Always take MAR-ESZOPICLONE exactly as your healthcare professional tells you to. Do not change your dose without talking to your healthcare professional.
• Take MAR-ESZOPICLONE right before you get into bed. Do not take MAR-ESZOPICLONE if a full night’s sleep is not possible before you need to become active and functional again.

• For earlier sleep onset, MAR-ESZOPICLONE should NOT be taken with or right after a meal.

• Swallow MAR-ESZOPICLONE tablets whole. Do not break or crush the MAR-ESZOPICLONE tablets.
• Do not consume any alcohol while taking MAR-ESZOPICLONE

Remember: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.

Usual dose:

• The usual adult starting dose is 1 mg.
• Based on your response and tolerability of MAR-ESZOPICLONE, your age, other medical conditions you have and other medicines you are taking, your healthcare professional may change your dose. Your healthcare professional will ensure the lowest effective dose is prescribed.

Your healthcare professional will slowly decrease your dose and will tell you when to stop taking the medicine. Always follow your healthcare professional’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.

Overdose:

Missed Dose:

If you miss a dose, do not take it in the middle of the night. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

What are possible side effects from using MAR-ESZOPICLONE?

These are not all the possible side effects you may feel when taking MAR-ESZOPICLONE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• falls and fractures
• unpleasant taste, dry mouth
• nausea, vomiting, stomach upset
• diarrhea
• change in appetite
• back pain
• headache
• drowsiness
• dizziness, lightheadedness
• difficulty with coordination
• decreased muscle tone
• abnormal weakness or lack of energy
• rash, itching
• nervousness, anxiety
• abnormal dreams

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15 to 30^oC).

Keep out of reach and sight of children.

If you want more information about MAR-ESZOPICLONE:

Marcan Pharmaceuticals Inc.

Last Revised: JUL 04, 2024