Common Technical Document Zolpidem hemitartrate Film-coated tablets
1.3.1 Package Leaflet – Core
Package leaflet: Information for the user
[Product name] <5 mg>
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What zolpidem is and what it is used for 2. What you need to know before you take zolpidem 3. How to take zolpidem 4. Possible side effects 5. How to store zolpidem 6. Contents of the pack and other information
1. What zolpidem is and what it is used for
Zolpidem belongs to a group of medicines known as benzodiazepine-like agents used for sleep disturbances.
Zolpidem is used for short-term treatment of insomnia in adults, only when the disorder is severe, disabling or causing extreme distress for the patient.
Do not use long-term. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
2. What you need to know before you take zolpidem
Do not take zolpidem if you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6). M1.3.1_03.ZIM.hta.tab.100.05.core Page 1 of 10
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if you suffer from severe muscle weakness (myasthenia gravis). if your breathing stops for short periods while you are sleeping (sleep apnoea syndrome). if you suffer from severe liver damage. if you suffer from severe and/or acute breathing weakness.
Warnings and precautions
General Talk to your doctor or pharmacist before taking zolpidem. The cause of the sleep disturbances should be clarified and if possible underlying diseases should be treated before a sleeping tablet is prescribed. If treatment of the sleep disturbances is not successful after 7-14 days, further investigation is needed.
Tolerance Repeated used of zolpidem or other sleeping tablets for a period of several weeks may impact on their effectiveness.
Dependence 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. The risk of abuse and dependence increases with the dose and duration of treatment and is greater 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.
If physical dependence has developed, sudden discontinuation of treatment may be accompanied by withdrawal symptoms such as headache, muscle pain, severe fear and tension, restlessness, confusion and irritability.
The following symptoms may be experienced in severe cases: a loss of sense of reality, isolating oneself from others, intensified hearing, a numb sensation and tingling in the arms and legs, oversensitivity to light, sound and touch, delusions or epileptic fits.
Rebound insomnia After stopping treatment with zolpidem or other sedatives, the symptoms applicable prior to treatment may return and have been exacerbated. Other reactions may occur too. For example, mood changes, fear and restlessness.
The chance of rebound symptoms is greater when treatment is ended suddenly. This is why use of Zolpidem must be reduced slowly.
Treatment duration The treatment duration must be as short as possible and never last more than 4 weeks including the stepwise withdrawal process. This period may only be extended following a re-evaluation of the patient’s condition.
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Memory defects (amnesia) Zolpidem or other sedatives may cause loss of memory (amnesia). This generally occurs some hours after intake of zolpidem. In order to minimise this risk, you should make sure that an uninterrupted sleep of 8 hours will be possible.
Psychiatric and contradictory “paradoxical" reactions The following complaints may be experienced when taking zolpidem: restlessness, increased sleep disturbances, agitation, irritability, aggression, delusion, anger, nightmare, mental disorders, sleepwalking, inappropriate behaviour and other adverse behavioural effects.
Use in combination with alcohol and other medicines seems to increase the risk of this behaviour. The use of a dose of zolpidem in excess of the maximum dose would seem to increase the risk of this behaviour too.
Sleepwalking and associated behaviour Sleepwalking and other associated behaviour, such as sleep driving, preparing and eating food, making telephone calls or having sex, in which memory loss occurs prior to the situation in question, has been reported in patients that had used zolpidem and were not fully awake. Use in combination with alcohol and other medicines would seem to increase the risk of this behaviour. The use of a dose of zolpidem in excess of the maximum dose would seem to increase the risk of this behaviour too. Discontinuation of zolpidem should be strongly considered for patients who report such behaviours (sleep driving, for example), due to the risk to the patient and others. Please tell your doctor if such behaviours occur.
Falling Use of benzodiazepines, including zolpidem, has been linked to an increased risk of falling. Falling may be caused by the side effects of benzodiazepines. For example, coordination problems, muscle weakness, dizziness, drowsiness and fatigue. The risk of falling is higher in older patients and if a higher dose is taken than the dose recommended.
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 the recommended dose You take zolpidem while you are already taking another 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.
Specific patient groups Zolpidem or other sedatives should be used with caution in patients: - with breathing difficulties. - who are displaying depressive symptoms (a risk of suicidal tendencies). A latent depression can become clear during the use of sedatives (pre-existing depression).
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- with a history of mental illness and/or alcohol or drug abuse. - with long QT syndrome (hereditary cardiac arrhythmia). The lowest quantity of zolpidem available should be issued.
Other medicines and zolpidem Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. While taking zolpidem with the following medicines, drowsiness and next-day psychomotor impairment effects, including impaired driving ability, may be increased: Medicines for some mental health problems (antipsychotics) Medicines for sleep problems (hypnotics) Medicines to calm or reduce anxiety Medicines for depressions Medicines for moderate to severe pain (narcotic analgesics) Medicines for epilepsy Medicines used for anesthesia Medicines for hay fever, rashes or other allergies that can make you sleepy (sedatives antihistamines)
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 or ciprofloxacin.
Medicines which strongly enhance the activity of certain liver enzymes can possibly reduce the effect of zolpidem e.g. rifampicin (an antibacterial used to treat for example, tuberculosis).
Zolpidem with food, drink and alcohol Alcohol should be avoided when taking zolpidem, as the sleeping effect of zolpidem could be increased by concurrent use with alcohol.
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 dose 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 dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Painkillers
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In the event of concurrent use with narcotic painkillers, you may experience an increased heightened sense of well-being, which could lead to increased mental (psychological) dependence.
St. John’s Wort and rifampicin Concurrent administration with St. John’s Wort or with rifampicin (a medicine that is used to fight tuberculosis) may reduce the effectiveness of zolpidem.
Ketoconazole Concurrent use with ketoconazole, an anti-fungal medicine, may strengthen the effectiveness of Zolpidem.
Pregnancy, breast-feeding and fertility
Pregnancy Use of zolpidem is not recommended during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice.
If used during pregnancy, there is a risk that the baby is affected. Some studies have shown that there may be an increased risk of cleft lip and palate (sometimes called “harelip”) in the newborn baby.
Reduced fetal movement and fetal heart rate variability may occur after taking during the second and/or third trimester of pregnancy.
If is taken at the end of pregnancy or during labour, your baby may show muscle weakness, a drop in body temperature, difficulty feeding and breathing problems (respiratory depression).
If this medicine is taken regularly in late pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.
Breast-feeding You should not breast-feed if you are taking zolpidem.
Driving and using machines Zolpidem has major influence on the ability to drive and use machines such as “sleep driving”. On the day after taking zolpidem (as other hypnotic medicines), you should be aware that: You may feel drowsy, sleepy, dizzy or confused Your quick decision-making may be longer Your vision may be blurred or double 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.
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Do not drink alcohol or take other psychoactive substances while you are taking zolpidem, as it can increase the above listed effects.
Zolpidem contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Zolpidem contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. How to take zolpidem
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose per 24 hours is 10 mg of zolpidem. A lower dose may be prescribed to some patients. Zolpidem should be taken: as a single intake, just before bedtime with a drink (for example with a glass of water)
Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require your alertness.
Do not exceed 10 mg per 24 hours.
Adults The usual dose is 10 mg (2 tablets). The usual dose is 10 mg (1 tablet).
Elderly or weak patients A starting dose of 5 mg (1 tablet). A starting dose of 5 mg (1/2 tablet).
Hepatic impairment A starting dose of 5 mg (1 tablet). A starting dose of 5 mg (1/2 tablet).
Children Zolpidem should not be used in children and adolescents under 18 years old given lack of data supporting its use in this age group.
Duration of treatment
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The duration of treatment should be as short as possible and should not be longer than four weeks, including the stepwise withdrawal process, since the risk of abuse and dependence increases with the duration of treatment. Your doctor can provide you with more information about the duration of treatment. Your doctor may extend the duration of treatment in some cases.
If you take more zolpidem than you should If you take more zolpidem than you should, contact your doctor or pharmacist immediately.
In case of overdosage symptoms could vary from extreme sleepiness to light coma. In the event of an overdose or suspected overdose, contact your doctor immediately.
If you forget to take zolpidem It can occur that you forget to take zolpidem. In that case, it is not necessary to take the forgotten tablet. Instead, take the dose prescribed by your doctor at the normal time. Do not take a double dose to make up for a forgotten dose.
If you stop taking zolpidem Do not stop taking zolpidem suddenly; you may experience withdrawal symptoms such as headache, muscle pain, extreme fear and tension, restlessness, confusion and irritability. Contact your doctor to stop treatment by gradually reducing the dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are mainly experienced when treatment starts: daytime drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, coordination problems (ataxia) and double vision. These side effects usually disappear as treatment progresses. Other side effects that are reported are gastro-intestinal complaints, changes in libido and skin reactions.
Common side effects (may affect up to 1 in 10 people) - Infections of the upper of lower respiratory tracts - Hallucinations, agitation, nightmares, worsening sleep disturbance, depression - Daytime drowsiness, numbed emotion, headache, dizziness, memory loss may occur several hours after taking zolpidem (anterograde amnesia; there is a bigger chance of this happening if you sleep less than 7 or 8 hours) - Diarrhoea, nausea, vomiting, stomach ache - Back pain - Fatigue
Uncommon side effects (may affect up to 1 in 100 people) - Appetite disorder
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- Confusion, irritability, restlessness, aggression, sleepwalking, euphoric mood - Tickling, itching or tingling sensations for no reason (paraesthesia), involuntary trembling (tremor), attention disorders, speech disorders - Blurred vision, double vision - Elevated liver enzymes - Rash, itching (pruritus), excessive sweating (hyperhidrosis) - Arthralgia, muscle pain, muscle spasms, neck pain, muscle weakness
Rare side effects (may affect up to 1 in 1,000 people) Changes in libido Reduced alertness, coordination problems (ataxia) Different types of liver damage Rash with severe itching (hives) and the development of bumps, hives Abnormal walking
Very rare side effects (affecting less than 1 in 10,000 people) - Reduced vision - Delusions, physical and mental dependence - Suppressed breathing
Not known side effects (frequency cannot be estimated from the available data) - Sudden fluid accumulation in the skin and mucous membranes (throat or tongue, for example), breathing difficulties and/or itching and a rash, often as an allergic reaction (angioneurotic oedema) - Outbursts of anger, abnormal behaviour and psychosis, abuse - Habituation - Falling (particularly among the elderly)
Depression that is present, but has not manifested itself yet may do so when you use zolpidem.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store zolpidem
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.
Store zolpidem in the original package. M1.3.1_03.ZIM.hta.tab.100.05.core Page 8 of 10
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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What zolpidem contains The active substance is zolpidem tartrate. Each tablet contains 5 mg zolpidem tartrate. Each tablet contains 10 mg zolpidem tartrate.
The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate type A, hypromellose and magnesium stearate. Tablet coating: titanium dioxide (E171), hypromellose and macrogol 400.
What zolpidem looks like and contents of the pack Zolpidem tartrate 5 mg tablets are white, oval, biconvex, film-coated, and debossed with “ZIM” on one side and “5” on the other side. Zolpidem tartrate 10 mg tablets are white, oval, biconvex, film-coated, scored on both sides, and debossed with "ZIM" and "10" on one side. The tablet can be divided into equal doses.
Zolpidem tartrate 5 mg tablets are available in: - cartons containing 4, 5, 7, 8, 10, 14, 15, 20, 28, 30, 50, 100 and 500 tablets packed in blisters. - cartons containing 50 tablets of hospital pack. - tablet containers containing 30, 100 or 500 tablets, sealed with a childproof closure. Not all pack sizes may be marketed. Zolpidem tartrate 10 mg tablets are also available on the market.
Zolpidem tartrate 10 mg tablets are available in: - cartons containing 4, 5, 7, 8, 10, 14, 15, 20, 28, 30, 50, 100 and 500 tablets packed in blisters. - cartons containing 50 tablets of hospital pack. - tablet containers containing 30, 100 or 500 tablets, sealed with a childproof closure. Not all pack sizes may be marketed. Zolpidem tartrate 5 mg tablets are also available on the market.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
[To be completed nationally]
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This leaflet was last revised in {MM/YYYY}.
[To be completed nationally]
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