Uses

Zopiclone is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and reduce the number of times you wake up during the night. Getting better sleep makes you feel well rested and improves your energy level. Zopiclone belongs to a class of drugs known as sedatives/hypnotics. It acts in your brain to produce a calming effect.

This medication is usually limited to short-term treatment periods of 7 to 10 days or less.

How To Use

Read the Patient Information Leaflet provided by your pharmacist before you start taking zopiclone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once nightly just before bedtime. Dosage is based on your medical condition, age, other medications you may be taking, and response to treatment. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Follow your doctor's instructions carefully. Do not take more of this medication than prescribed because your risk of side effects will increase.

Although unlikely, this drug may rarely cause temporary memory loss. To avoid this effect, do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. This amount of time is needed for your body to get over the effects of this drug. For example, do not take zopiclone to help you sleep during an overnight plane flight of less than 7 to 8 hours.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as stomach/muscle cramps, shaking, sweating, anxiety, vomiting, rare seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used zopiclone for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and it is normal. It will usually go away after 1 to 2 days. If this effect continues, contact your doctor.

Tell your doctor if your condition lasts after 7 to 10 days, or if it gets worse.

Side Effects

See also Warning section.

Dizziness, lightheadedness, bitter taste, dry mouth, or stomach upset may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

To reduce the chance of falling, remember to get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fast/pounding heartbeat
• memory loss
• loss of coordination
• mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, rare thoughts of suicide, confusion, anxiety, restlessness, aggression)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking zopiclone, tell your doctor or pharmacist if you are allergic to it; or to eszopiclone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• lung/breathing problems (such as asthma, emphysema, sleep apnea)
• a certain muscle disease (myasthenia gravis)
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• mental/mood/behavior disorders (such as depression, personality disorders, confusion)
• personal or family history of sleepwalking
• kidney disease
• liver disease

The effects of this drug can last even after you wake up the next day. If you did not get 7 to 8 hours of sleep or took other medications that made you sleepy or are more sensitive to this drug, you may feel alert but not think clearly enough to drive. Alcohol or marijuana (cannabis) can also make you more sleepy. Wait at least 12 hours after taking this drug before driving, and do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially extreme drowsiness, dizziness, increased risk for falls, memory loss, confusion, fast/pounding heartbeat.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using zopiclone. Zopiclone may harm an unborn baby. This drug may cause withdrawal symptoms and other problems in a newborn baby when used for a long time during pregnancy or near the time of delivery. If you become pregnant or think you may be pregnant, talk to your doctor right away about the risks and benefits of this medication. Consult your doctor for more details.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• sodium oxybate

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Zopiclone is very similar to eszopiclone. Do not use medications containing eszopiclone while using zopiclone.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, trouble speaking, a deep sleep from which you cannot be awakened.

Notes

Do not share this medication with others. Sharing it is against the law.

As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night.

Missed Dose

If you miss a dose, do not take it unless you have time to sleep for 7 to 8 hours afterward. (See also How to Use section.)

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.