Details for: ZOPICLONE

Complex sleep behaviours:

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 doing those activities. The activities you may do in these situations can put you and people around you in danger and can cause serious injuries or death. Reported activities included driving a car (“sleepdriving”), leaving the 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 ZOPICLONE. If you experience any of the above, stop taking ZOPICLONE immediately and contact your doctor or healthcare professional.

Important:

1. Do not take more 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 ZOPICLONE if 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 all of your medicines, including overthe-counter medicines and herbal products. Your doctor will tell you if you can take ZOPICLONE with your other medicines.
7. You and people close to you should watch for the complex sleep behaviours described above. If you find out that you have done any such activities for which you have no memory you should call your doctor immediately.

Mental Alertness: ZOPICLONE may 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: ZOPICLONE may cause a special type of memory loss (amnesia); you may not recall events that occurred during some period of time, usually several hours, after taking the drug. This lapse is usually not a problem, because the person taking the sleeping pill intends to be asleep during this critical period of time. But it can be a problem if you take the medication to induce sleep while travelling, such as during an airplane flight, because you may wake up before the effect of the drug is gone. This has been called “traveller’s amnesia”. DO NOT TAKE ZOPICLONE when a full night's sleep is not possible before you would again need to be active and functional; e.g., an overnight flight of less than 8 hours. Memory lapses may occur in 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 effectiveness and you may also develop a degree of dependence.

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

You may also experience “withdrawal effects” when you stop the medication after taking it for only a week or two. But usually, these withdrawal effects are more common and severe after long periods of continuous use. For instance, on the first few nights after stopping the medication, you may find that insomnia is worse than before taking the sleeping pills. This type of withdrawal symptom is known as “rebound insomnia”.

Other withdrawal effects following abrupt stopping of sleeping pills may range from unpleasant 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 few weeks, or at higher doses. Some people develop a need to continue taking these drugs, not only for continued therapeutic effect, but also to avoid withdrawal symptoms or to achieve non-therapeutic effects.

Individuals who depend, or have depended at any time in the past, on alcohol or other drugs may be at particular risk of becoming dependent on drugs of this class. But all people are at some risk. Consider this matter before you take these medications beyond the recommended 7 to 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 thinking and behavioural changes may occur when you use prescription sleeping pills. Some of these changes include aggressiveness and extroversion which seem out 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 clear whether such symptoms are caused by the medication, or by an illness that was present before the medication was used, or are simply spontaneous happenings. If you develop any unusual disturbing thoughts or behaviour while using ZOPICLONE, discuss the matter immediately with your doctor.

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

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

BEFORE you use 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 ZOPICLONE 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 history of depression and/or suicide thoughts or attempts.
• have had unexpected reactions to 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 pregnant while taking this medication.
• are breastfeeding.
• consume alcohol.
• are taking opioid medicines or other central nervous system depressants such as sedative or hypnotics (see INTERACTIONS WITH THIS MEDICATION), as well as if you are taking any other medicines, including over-the counter medicines and herbal products.
• have lactose intolerance.