Details for: APO-ZOLPIDEM ODT

Need to diagnose other existing conditions

Sleep problems can be a symptom of many physical and psychiatric disorders. Your doctor will need to evaluate your medical history before initiating treatment with APO-ZOLPIDEM ODT. If your sleep problems do not stop after 7 to 10 days of treatment, this is an indication that there is another original illness that need to be evaluated. Worsening of your sleep problems or the developing of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including APO-ZOLPIDEM ODT.

Severe allergic reactions

Rare cases of swelling involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of sedative -hypnotics, including zolpidem tartrate. Some patients have had additional symptoms such as shortness of breath, throat closing, or nausea and vomiting that suggest an allergic shock reaction (which is a sudden severe and potentially fatal allergic reaction in somebody sensitive to a substance, marked by a drop in blood pressure, difficulty in breathing, itching, and swelling). Some patients have required medical therapy in the emergency department. Get emergency medical help if you get these symptoms after taking APO-ZOLPIDEM ODT.

If you suffered once from the above, you should not take this drug again.

Mental Alertness: APO-ZOLPIDEM ODT may affect your ability to be alert the next day after taking it. DO NOT DRIVE A CAR or operate potentially dangerous machinery until you experience how this drug will affect you.

Memory problems: APO-ZOLPIDEM ODT 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 APO-ZOLPIDEM ODT 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 APO-ZOLPIDEM ODT, 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 a few weeks.

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, irritability, illusions, nightmares, hallucinations, 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 APO-ZOLPIDEM ODT, discuss the matter immediately with your doctor.

Worsening of Side Effects
DO NOT CONSUME ALCOHOL WHILE TAKING APO-ZOLPIDEM ODT. Some medicines may also worsen side effects that some patients experience with APO-ZOLPIDEM ODT (see Interactions with this medication).

Elderly (65 years of age or older): An increased risk of falls and fractures has been reported in elderly people who take sleeping pills such as APO-ZOLPIDEM ODT. A lower dose is recommended in the elderly (see Proper Use of this Medication).

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 APO-ZOLPIDEM ODT 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 APO-ZOLPIDEM ODT at anytime during pregnancy, it may affect the developing baby.

Use in Nursing Mothers: APO-ZOLPIDEM ODT 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 APO-ZOLPIDEM ODT talk to your doctor or pharmacist if:

• you have a lung disease or breathing problems
• you have myasthenia gravis
• any other diseases
• you suffer from depression or have a history of depression and/or suicidal thoughts
• you are taking any other medicines, including over-the- counter medicines and herbal products
• You consume alcohol.
• You have had unexpected reactions to alcohol or sedative medications in the past, such as irritability, aggression, hallucinations, etc.
• you have a history of addiction to, or abuse of drugs or alcohol
• you have a liver or kidney disease
• you are pregnant or planning to become pregnant, or if you become pregnant while taking this medication
• you are breast feeding