Details for: TARO-ZOPICLONE

Complex sleep-related 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. This unusual behaviour is more likely to occur when zopiclone is taken with alcohol or other drugs that can make you sleepy such as those for the treatment of depression or anxiety. The activities you may do in these situations can put you and people around you in danger. Reported activities included driving a car (“sleepdriving”), leaving the house, making and eating food, talking on the phone, etc.

Important:

1. Do not take more TARO-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 TARO-ZOPICLONE if you drink alcohol.
4. TARO-ZOPICLONETalk 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 over-the-counter medicines and herbal products. Your doctor will tell you if you can take TARO-ZOPICLONE with your other medicines.
7. You and people close to you should watch for the type of unusual behaviour 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:

Memory problems: TARO-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 TAROZOPICLONE 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 TARO-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.

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 7-10 days, because longer treatment times increase the risk of dependence. The risk of dependence is also greater in patients with a history of mental disorders 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 TAROZOPICLONE, discuss the matter immediately with your doctor.

Worsening of Side Effects

DO NOT CONSUME ALCOHOL WHILE TAKING TARO-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 TARO-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 TARO-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 TARO-ZOPICLONE talk to your doctor or pharmacist if:

• You have a lung disease or breathing problems.
• You have liver or kidney condition.
• You have a mental disorder.
• You have a history of depression and/or suicide thoughts or attempts.
• You have had unexpected reactions to alcohol or sedative medications in the past, such as irritability, aggression, hallucinations, etc.
• You have a history of drug or alcohol abuse or addiction.
• You are planning to become pregnant, if you are pregnant, or if you become pregnant while taking this medication.
• You are breastfeeding.
• You consume alcohol.
• You are taking opioid medicines or other central nervous system depressants such as sedative or hypnotics (see INTERACTIONS WITH THIS MEDICATIONS), as well as if you are taking any other medicines, including over-the- counter medicines and herbal products