Product Details

What you need to know before you take zolpidem

Do not take zolpidem if: • You are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • You have a problem where you stop breathing for short periods at night (sleep apnoea). • You have a problem that causes severe muscle weakness (myasthenia gravis). • You have breathing difficulties (hypoventilate). • You have severe liver problems. • You have been told by a doctor that you have a mental illness (psychosis). • You are under the age of 18. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking zolpidem. Warnings and precautions Talk to your doctor or pharmacist before taking zolpidem if: • You have a history of alcohol or drug abuse. • Your lungs do not work properly. • You have any liver problems. • You have depression or have had another mental illness in the past. • You have recently taken zolpidem or other similar medicines for more than 4 weeks. Use of Zolpidem may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence is greater when zolpidem is used for longer than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substance or drug abuse. Tell your healthcare provider if you have ever had a mental disorder or have abused or have been dependent on alcohol, substance or drugs. Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice. Zolpidem can cause drowsiness and decrease your level of alertness. This could cause you to fall, sometimes leading to severe injuries. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking zolpidem. Next day psychomotor impairment (see also ‘Driving and using machines’) The day after taking zolpidem, the risk of psychomotor impairment, including impaired driving ability may be increased if: • You take this medicine less than 8 hours before performing activities that require your alertness. • You take a higher dose than recommended. • You take zolpidem while you are already taking other central nervous system depressants or other medicines that increase zolpidem in your blood, or while drinking alcohol, or while taking illicit substances. Take the single intake immediately at bedtime. Do not take another dose during the same night. Other medicines and zolpidem Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because zolpidem can affect the way some other medicines work. Also some medicines can affect the way zolpidem works. Zolpidem may increase the effect of the following medicines: While taking zolpidem with the following medicines, drowsiness and nextday psychomotor impairment effects, including impaired driving ability, may be increased: • Medicines for mental problems (antipsychotics). • Medicines for depression such as sertraline. • Some medicines for moderate to severe pain (narcotic analgesics). • Medicines for epilepsy (anticonvulsants). • Medicines used in surgery (anaesthetics). • Medicines to calm or reduce anxiety or for sleep problems (hypnotics). • Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine. While taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not real (hallucinations). It is not recommended to take zolpidem with fluvoxamine, ciprofloxacin or St. John’s Wort (a herbal medicine) used for mood swings and depression. Risks from concomitant use with opioids Concomitant use of zolpidem and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe zolpidem together with opioids the dosage and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign and symptoms stated above. Contact your doctor when experiencing such symptoms. The following medicines can increase the chance of you getting side effects when taken with zolpidem. To make this less likely, your doctor may decide to lower your dose of zolpidem: • Some medicines for fungal infections such as ketaconazole. The following medicines can make zolpidem work less well: • Rifampicin (an antibiotic) – for infections. Zolpidem with alcohol Do not drink alcohol while you are taking zolpidem. Alcohol can increase the effects of zolpidem and make you sleep very deeply so that you do not breathe properly or have difficulty waking. Pregnancy and breast-feeding Pregnancy Use of this medicine is not recommended during pregnancy. If you discover that you are pregnant or are planning to have a baby, consult your doctor right away to re-assess the need for treatment. A large amount of data has not shown evidence of malformations with benzodiazepines. However, some epidemiological studies have shown a potentially increased risk of cleft lip and palate in newborn babies compared to that in the general population. Cleft lip and palate (sometimes called “harelip”) is a deformation at birth caused by incomplete fusion of the palate and upper lip. Reduced fetal movement and fetal heart rate variability may occur after taking zolpidem during the second and/or third trimester of pregnancy. If taken at the end of pregnancy muscle weakness (hypotonia), a drop in body temperature (hypothermia), difficulty feeding (problems suckling causing poor weight gain) and breathing problems (respiratory depression) may occur in the newborn. If taken regularly in late pregnancy, your baby may get withdrawal symptoms. In this case the newborn should be closely monitored during the postnatal period. Breast-feeding Do not take zolpidem if you are breast-feeding or planning to breast-feed. This is because small amounts may pass into mothers’ milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines On the day after taking zolpidem, do not drive or use machinery or tools if you feel sleepy, dizzy or confused. Zolpidem has a major influence on the ability to drive and use machines such as ‘sleep driving’. On the day after taking zolpidem (as with other hypnotic medicines), you should be aware that: • You may feel drowsy, sleepy, dizzy or confused. • You may take longer to make quick decisions. • You may have double or blurred vision. • You may be less alert. A period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights to minimize the above listed effects. Do not drink alcohol or take other psychoactive substances while you are taking zolpidem as it can increase the above listed effects. Important information about the ingredients of zolpidem This medicine contains Lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before having this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’