Zolpigen

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

ZolpiGen, 10 mg, coated tablets

Zolpidem tartrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is ZolpiGen and what is it used for
• 2. Important information before taking ZolpiGen
• 3. How to take ZolpiGen
• 4. Possible side effects
• 5. How to store ZolpiGen
• 6. Contents of the pack and other information

1. What is ZolpiGen and what is it used for

ZolpiGen contains zolpidem, an active substance belonging to the group of sedative-hypnotic medicines.
ZolpiGen tablets are sleeping tablets that cause sleepiness as a result of their effect on the brain.
This medicine may be used for short-term treatment of insomnia in adults, if it is severe,
interferes with normal functioning or is very bothersome. Insomnia means problems
with falling asleep or proper sleep.

2. Important information before taking ZolpiGen

When not to take ZolpiGen:

• if the patient is allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue,
• if the patient has severe liver function disorders,
• if the patient has sleep apnea syndrome (characterized by short pauses in breathing during sleep),
• if the patient has significant muscle weakness (myasthenia),
• if the patient has acute and/or severe respiratory disorders.
• if the patient has experienced sleep disorders after taking zolpidem tartrate in the past

Warnings and precautions

Before starting treatment with ZolpiGen, discuss it with your doctor:

• if the patient is elderly or weakened. The patient should be cautious when getting up at night. ZolpiGen may relax muscles and cause sleepiness, which increases the risk of falls and thus the risk of hip fracture,
• if the patient has liver or kidney function disorders,
• if the patient has a history of respiratory disorders. During treatment with ZolpiGen, breathing may become weaker,
• if the patient has a history of mental illness, anxiety or psychosis, as ZolpiGen may reveal or exacerbate symptoms of these diseases,
• if the patient currently has or has had depression (feeling of sadness),
• if the patient currently has or has had a mental illness, a tendency to abuse alcohol or drugs. The risk of dependence on ZolpiGen (physical or psychological symptoms caused by the feeling of needing to take the medicine constantly) increases in such patients. This risk increases with higher doses and longer treatment.

Children and adolescents

ZolpiGen should not be used in children and adolescents under 18 years of age.

Other problems

• General - before administering the medicine, the doctor will assess the patient's sleep problems to ensure they are not caused by a disease. If the medicine does not help the patient after 7-14 days, they should consult a doctor, as something else may be causing the problems and needs to be diagnosed.
• Tolerance (habituation) - if after a few weeks the patient notices that the medicine is no longer working as well as at the beginning of treatment, they should consult a doctor. A dose change may be necessary.
• Dependence - when using this type of medicine, there is a risk of dependence, which increases with dose and treatment duration. The risk is higher in patients with mental illness and in patients who currently or in the past have abused alcohol or drugs.
• Withdrawal - the medicine should be discontinued gradually. After discontinuing the medicine, a short-term withdrawal syndrome may occur, characterized by the return of symptoms that required treatment with ZolpiGen in an exacerbated form. Other reactions, such as mood changes, anxiety, and restlessness, may accompany this.
• Amnesia - ZolpiGen may cause memory loss. To minimize the risk of its occurrence, the patient should ensure that they will have the opportunity for uninterrupted sleep lasting 8 hours.
• Psychological reactions and "paradoxical" - ZolpiGen may cause undesirable changes in behavior, such as restlessness, excitement, irritability, aggression, delusions (false beliefs), outbursts of anger, nightmares, hallucinations (when the patient sees, hears or feels things that are not really there), psychoses (when the patient loses contact with reality, is unable to think clearly and evaluate), inappropriate behavior, and increased insomnia.
• Somnambulism and similar behaviors - ZolpiGen may cause patients to perform various activities during sleep, which they do not remember after waking up. These activities may include: sleepwalking, driving while sleeping, preparing and consuming meals, making phone calls or having sexual intercourse. These sleep disorders may occur after taking ZolpiGen. If any of the above behaviors occur in the patient, they should immediately stop treatment with ZolpiGen and consult a doctor, as such behaviors during sleep can pose a serious risk of injury to the patient or their environment. Alcohol and certain medicines used to treat depression or anxiety, or taking ZolpiGen in doses higher than the maximum recommended dose, may increase the risk of these symptoms.
• Suicide - there have been reports of an increased number of suicides and attempted suicides in patients with depression or without depression, treated with zolpidem. However, the relationship between these events and the use of zolpidem has not been established
• Heart rhythm disorders (long QT syndrome) - if the patient has a heart disorder known as QT prolongation, which can be detected by an ECG, the doctor

will consider whether this medicine is suitable for the patient.

• Psychomotor disorders the next day (see also "Driving and operating machinery") - the next day after taking ZolpiGen, the risk of psychomotor disorders, including impaired driving ability, may be increased if:
• the patient took the medicine less than 8 hours before activities that require increased mental alertness
• the patient took a higher dose than recommended
• the patient took zolpidem during treatment with other medicines that have a sedative effect on the central nervous system or other medicines that increase the concentration of zolpidem in the blood, while consuming alcohol or taking prohibited substances. A single dose should be taken directly before sleep. Do not take another dose the same night.

ZolpiGen and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those bought without a prescription. ZolpiGen may affect the action and/or side effects of other medicines. If surgery under general anesthesia is planned, tell your doctor about all medicines being taken.
When using zolpidem with certain medicines, sleepiness and psychomotor disorders the next day, including impaired driving ability, may be increased. These medicines include:

• medicines used to treat certain mental health disorders (antipsychotics)
• medicines used to treat sleep problems (sleeping tablets)
• medicines that have a sedative or anxiolytic effect
• medicines used to treat depression
• medicines used to treat moderate to severe pain (opioid painkillers)
• medicines used to treat epilepsy
• medicines used in anesthesia
• medicines used to treat hay fever, rash, or other allergies that may cause sleepiness in the patient (sedating antihistamines)

When taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not real (visual hallucinations).
It is not recommended to take zolpidem with fluvoxamine, ciprofloxacin, and St. John's wort (a herbal medicine used in mood swings and depression).

Risk associated with concomitant use with opioids

Concomitant use of ZolpiGen and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of sleepiness, breathing difficulties (respiratory failure), coma, and can be fatal. Due to this, concomitant use of these medicines should only be considered when other treatment options are not possible.
However, when the doctor prescribes ZolpiGen together with opioids, the dose and duration of concomitant use should be limited by the doctor.
Inform your doctor about all opioid medicines being taken and strictly follow the dosage instructions. It may be helpful to inform friends and family members so that they are aware of the above signs and symptoms. In case of their occurrence, consult a doctor.
The following medicines may increase the risk of side effectswhen used with ZolpiGen. To minimize this probability, the doctor may decide to reduce the dose of ZolpiGen:

• certain antifungal medicines, e.g. ketoconazole

The following medicines may weaken the effect of ZolpiGen:

• rifampicin, an antibiotic used to treat infections

ZolpiGen with alcohol

Do not drink alcohol while taking ZolpiGen, as it may enhance the sedative effect of the medicine.

Pregnancy and breastfeeding

ZolpiGen should not be used during pregnancy, especially in the first three months of pregnancy. If a patient is given ZolpiGen at the end of pregnancy or during childbirth, the baby may experience hypothermia, muscle weakness, feeding difficulties, and breathing difficulties, as well as withdrawal symptoms due to physical dependence.
Some studies have shown an increased risk of cleft lip and palate in newborns (so-called "hare lip").
Using zolpidem in the second and/or third trimester of pregnancy may reduce fetal movement and change the fetal heart rate.
Do notbreastfeed, as small amounts of zolpidem may pass into breast milk.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.

Driving and operating machinery

ZolpiGen has a major impact on the ability to drive and operate machinery, may cause events such as falling asleep at the wheel. The next day after taking ZolpiGen (like other sleeping tablets), it may happen that:

• the patient feels drowsy, sleepy, has dizziness or is disoriented
• the patient needs more time to make quick decisions (impaired reflex)
• the patient may see blurred or double vision
• the patient may be less alert

To minimize the risk of the above events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, or working at heights.
Do not drink alcohol or psychoactive substances while taking ZolpiGen, as it may enhance the above effects.

ZolpiGen contains lactose

If the doctor has ever mentioned intolerance to some sugars, such as lactose, before starting treatment with this medicine, consult a doctor.

3. How to take ZolpiGen

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine works immediately, so the tablet should be swallowed whole with a liquid, just before going to sleep or after lying down. After taking this medicine, ensure at least 8 hours of sleep.
The tablet can be divided into equal doses.
Adults:The recommended dose of ZolpiGen is 10 mg per 24 hours. Some patients may be prescribed a lower dose by their doctor. ZolpiGen should be taken:

• in a single dose
• directly before sleep

The patient must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased concentration.
Do not exceed the dose of 10 mg per 24 hours.
Elderly or weakened patients (over 65 years old):The recommended dose is 5 mg.
Patients with liver function disorders:The recommended initial dose is 5 mg. The doctor may increase the dose to 10 mg if they consider it safe.
The maximum dose of 10 mg should not be exceeded in any patient.

Use in children and adolescents:

ZolpiGen should not be used in patients under 18 years of age.
If the patient notices that the medicine is no longer working as well as at the beginning of treatment, they should consult a doctor, as a dose change may be necessary.

Duration of treatment

The treatment period should be as short as possible. It usually ranges from a few days to 2 weeks.
The maximum treatment duration, including the tapering-off period, is 4 weeks.
The doctor will determine the tapering-off schedule based on the individual needs of the patient.
In some cases, it may be necessary to use the medicine for a period longer than 4 weeks.
The risk of dependence increases with the duration of treatment (see section 2 "Other problems").

Using a higher dose of ZolpiGen than recommended

If the patient (or anyone else) swallows a large number of tablets at once or if it is suspected that a child has swallowed any tablets, they should immediatelyconsult a doctor or go to the emergency department of the nearest hospital. They should take the packaging of the medicine and any remaining tablets with them. Do not go to the doctor alone. If an overdose occurs, sleepiness may increase rapidly, and high doses may lead to coma or even death.

Missing a dose of ZolpiGen

If the patient forgets to take a dose of the medicine before going to sleep, but remembers it in the middle of the night, the missed dose can be taken only if it is possible to ensure 8 hours of uninterrupted sleep after taking the tablet. If this is not possible, the next dose should be taken before going to sleep the next evening. Do not take this medicine at any other time of day, as it may cause sleepiness, dizziness, or disorientation in the patient. Do not take a double dose to make up for a missed dose. In case of doubt, consult a pharmacist or doctor.

Stopping treatment with ZolpiGen

ZolpiGen should be used for as long as the doctor recommends. Do not stop treatment abruptly, but inform your doctor about the intention to stop using it. Treatment should be discontinued gradually, otherwise, the sleep disorders for which the medicine is used may return in an even more severe form (rebound insomnia). Other reactions, such as anxiety, restlessness, and mood changes, may also occur. These symptoms will subside after some time.
If physical dependence on ZolpiGen occurs, sudden discontinuation of the medicine may lead to side effects such as headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, and insomnia. In severe cases, other symptoms, such as hypersensitivity to light, noise, and touch, abnormal hearing acuity, and sensitivity to sounds, hallucinations, tingling, and numbness of limbs, feeling of unreality (feeling that the world around is not real), depersonalization (feeling that the mind is separating from the body), or seizures (convulsions or tremors), may also occur. Such symptoms may also be experienced during periods between doses, especially when high doses are used.
In case of any further doubts about the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, ZolpiGen can cause side effects, although not everybody gets them.

Stop taking the medicine and consult a doctor or go to the emergency department of the nearest hospital if:

• the patient experiences an allergic reaction. Symptoms may include skin rash, itching, swelling of the face, lips, throat or tongue, difficulty breathing or swallowing

If any of the following symptoms occur, tell your doctor as soon as possible:

Common(may affect up to 1 in 10 people):

• memory disorders (amnesia) or strange behavior while taking ZolpiGen (see section 2 "Other problems"). The risk of these symptoms may be higher within a few hours of taking the medicine. If the patient has 8 hours of sleep after taking the tablet, the risk of amnesia is lower.
• sleep problems, which may worsen after taking this medicine
• seeing or hearing things that are not real (hallucinations)
• increased sleepiness or fatigue, problems with concentration or daily activities.

Uncommon(may affect up to 1 in 100 people):

• double vision

Rare(may affect up to 1 in 1,000 people):

• liver damage, which may include symptoms such as severe abdominal pain, nausea, vomiting, loss of appetite, and yellowing of the skin and eyes
• falls (especially in elderly patients)

Very rare(may affect up to 1 in 10,000 people)

• psychological dependence: the patient thinks they will not fall asleep if they do not take ZolpiGen
• breathing difficulties

Frequency not known(frequency cannot be estimated from the available data):

• physical dependence: use (even at therapeutic doses) may lead to physical dependence, and sudden discontinuation of treatment may cause withdrawal symptoms and recurrence of problems
• loss of contact with reality (psychosis)

These side effects are serious. If they occur, the patient may need medical attention.

If any of the following side effects occur or worsen, tell your doctor or pharmacist:

Common(may affect up to 1 in 10 people):

• restlessness, nightmares
• headache, dizziness
• depression (feeling of sadness)
• diarrhea, nausea or vomiting, abdominal pain
• back pain
• fatigue
• infections of the nose and throat

Uncommon(may affect up to 1 in 100 people):

• irritability, confusion, restlessness, aggression
• muscle weakness
• tremors
• somnambulism (sleepwalking) and sleep disorders (see section 2 "Warnings and precautions)
• unusual state of cheerfulness and confidence (euphoric mood)
• speech disorders
• rash, itching
• excessive sweating
• increased liver enzyme activity (detected by blood tests)

Rare(may affect up to 1 in 1,000 people):

• paradoxical reactions (restlessness, excitement, irritability, aggression, delusions - false beliefs, outbursts of anger, nightmares, hallucinations, psychoses, inappropriate behavior, and other undesirable changes in behavior). Elderly patients are more prone to these symptoms
• decreased libido
• hives

Very rare(may affect up to 1 in 1,000 people):

• delusions (false beliefs)

Frequency not known(frequency cannot be estimated from the available data):

• blurred vision
• loss of appetite
• anger
• behavioral disorders
• delirium (sudden and severe change in mental state, which causes the person to appear lost or disoriented)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZolpiGen

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ZolpiGen contains

The active substance of ZolpiGen is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
The other ingredients of the medicine are: lactose monohydrate (see section 2, "ZolpiGen contains lactose"), microcrystalline cellulose, maize starch, magnesium stearate.
Tablet coating Opadry YS-1R-7003: titanium dioxide (E171), hypromellose 3cP, hypromellose 5cP, macrogol 400, polysorbate 80.

What ZolpiGen looks like and contents of the pack

ZolpiGen is a white or almost white, film-coated tablet in the shape of a capsule, marked as follows: "ZM with a dividing line 10" on one side and "G" on the other side.
The tablet can be divided into equal doses.
The pack contains 10 or 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN

Manufacturer

Mylan Dublin
35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
D13R20R
Ireland
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary
For more information on this medicine, please contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Zolpidem Viatris 10 mg coated tablets
Hungary: Somnogen 10 mg film-coated tablet
Poland: ZolpiGen
Portugal: Zolpidem Mylan
Slovakia: Zolpidem Viatris 10 mg

Date of last revision of the leaflet:March 2024