Zolsana

Leaflet attached to the packaging: information for the user

Zolsana, 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, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Zolsana and what is it used for

Zolsana belongs to a group of medicines similar to benzodiazepines, used to treat sleep disorders.
Zolsana is used for short-term treatment of insomnia in adults, only when sleep disorders are severe, disabling, or causing extreme exhaustion.
The medicine is not intended for long-term use. Treatment should be as short as possible, as the risk of dependence increases with the duration of treatment.

2. Important information before taking Zolsana

When not to take Zolsana:

• if the patient is allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe muscle weakness (myasthenia gravis);
• if the patient has short-term breathing pauses during sleep (sleep apnea syndrome);
• if the patient has severe liver damage;
• if the patient has acute and/or severe respiratory failure.

Warnings and precautions: General information

Before starting treatment with Zolsana, the patient should discuss it with their doctor or pharmacist. Before taking a sleeping pill, the cause of sleep disorders should be explained, and if possible, the underlying diseases should be treated.
If sleep disorders do not improve after 7 to 14 days of treatment, further investigations are necessary.
Tolerance
Repeated use of Zolsana or other sleeping pills for several weeks may affect their efficacy.
Dependence
Taking Zolsana may lead to misuse and/or development of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is higher when the medicine is taken for more than 4 weeks. The risk of misuse and dependence is higher in patients with a history of mental disorders and/or those who have previously misused alcohol, illicit substances, or medicines. The patient should inform their doctor if they have ever had mental disorders, misused, or been dependent on alcohol, substances, or medicines.
If physical dependence occurs, sudden withdrawal of the medicine may cause withdrawal symptoms, such as headache, muscle pain, severe anxiety and tension, restlessness, disorientation, and irritability.
In severe cases, the following symptoms may occur: loss of sense of reality, social withdrawal, increased sensitivity to sound, feeling of numbness and tingling in hands and feet, hypersensitivity to light, sound, and touch, hallucinations, or convulsions.
Rebound insomnia
After stopping treatment with zolpidem or other sedatives, the symptoms that led to the prescription of the medicine may return or worsen. Other reactions, such as mood changes, anxiety, and restlessness, may also occur.
The risk of rebound insomnia is higher when treatment is stopped abruptly, so it is recommended to gradually reduce the dose of the medicine.
Duration of treatment
The duration of treatment should be as short as possible and not exceed 4 weeks, including the period of gradual dose reduction. The duration of treatment may be extended only after re-evaluation of the patient's clinical condition.
Memory disorders (amnesia)
Zolsana or other sedatives may cause memory loss (amnesia). This condition usually occurs a few hours after taking Zolsana. To minimize the risk of this symptom, the patient should have 8 hours of uninterrupted sleep.
Psychological reactions and "paradoxical" (opposite) reactions
During treatment with Zolsana, the following side effects may occur: restlessness, worsening of sleep disorders, excitement, irritability, aggression, delusions, outbursts of anger, nightmares, mental disorders, sleepwalking, and other behavioral disorders.
Taking Zolsana with alcohol or other medicines may increase the risk of such behaviors, as well as taking the medicine in doses higher than the recommended maximum dose.
Sleepwalking and related behaviors
In patients who have taken Zolsana and have not woken up completely, sleepwalking and other related behaviors, such as driving while asleep, preparing and eating food, making phone calls, or having sex while asleep, have been reported, which the patients do not remember. It seems that taking Zolsana with alcohol or other medicines may increase the risk of such behaviors, as well as taking the medicine in doses higher than the recommended maximum dose. The patient should consider stopping the medicine if such behaviors occur (e.g., driving while asleep), due to the risk to the patient and others. The patient should consult their doctor if such behaviors occur.
Falls
Taking benzodiazepines, including Zolsana, has been associated with an increased risk of falls. These may be caused by benzodiazepine side effects, such as coordination problems, muscle weakness, dizziness, drowsiness, and fatigue. The risk of falls is higher in elderly patients and when higher-than-recommended doses are taken.
Psychomotor disorders the next day (see also "Driving and operating machinery")
The next day after taking Zolsana, 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 alertness;
• the patient took a higher dose than recommended;
• the patient took zolpidem while being treated 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 while taking illicit substances.

The patient should take a single dose directly before bedtime.
The patient should not take another dose on the same night.
Special patient groups
Cautions should be exercised when taking Zolsana or other sedatives in patients:

• with breathing disorders
• with symptoms of depression (due to the risk of suicidal tendencies). During treatment with sedatives, previously existing depression may become apparent
• with a history of mental disorders and/or substance or medicine misuse
• with a prolonged QT interval syndrome (inherited heart rhythm disorders) The doctor should prescribe the smallest available package of the medicine.

Zolsana and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
When taking zolpidem with certain medicines, drowsiness and psychomotor disorders the next day, including impaired driving ability, may be increased. These medicines include:

• medicines used to treat certain mental disorders(antipsychotics),
• medicines used to treat sleep disorders(sleeping pills),
• medicines that have a sedative or anxiolytic effect,
• medicines used to treat depression,
• medicines used to treat moderate to severe pain(narcotic painkillers),
• medicines used to treat epilepsy,
• medicines used in anesthesia,
• medicines used to treat hay fever, skin rash, or other allergiesthat may cause drowsiness 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 or ciprofloxacin.
Medicines that strongly increase the activity of certain liver enzymes may reduce the effectiveness of Zolsana, such as rifampicin (an antibacterial medicine used, for example, in the treatment of tuberculosis).
Zolsana with food, drink, and alcohol
During treatment, the patient should avoid consuming alcoholat the same time, as it may enhance the sedative effect of the medicine.
Opioids
Taking Zolsana and opioids (strong painkillers, medicines used in substitution therapy for addiction, and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. Therefore, taking these medicines together can only be considered if other treatment options are not possible.
If the doctor prescribes Zolsana with opioids, they should limit the dose and duration of concurrent use.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the dosage instructions. It may be helpful to inform friends or family about the risk, so they are aware of the signs and symptoms. If these symptoms occur, the patient should contact their doctor.
Painkillers
When taking Zolsana with narcotic painkillers, an exceptionally good feeling may occur, which can lead to increased psychological dependence.
St. John's Wort and rifampicin
Taking Zolsana with St. John's Wort or rifampicin (a medicine used to treat tuberculosis) may reduce the effectiveness of zolpidem.
Ketoconazole
Taking Zolsana with ketoconazole (an antifungal medicine) may increase the effectiveness of zolpidem.

Pregnancy, breastfeeding, and fertility

Pregnancy
Zolpidem should not be taken during pregnancy. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor.
If the medicine is taken during pregnancy, there is a risk that it may affect the development of the child.
Some studies have shown that newborns may have an increased risk of cleft lip and palate (sometimes called a harelip).
When taking the medicine in the second and/or third trimester of pregnancy, reduced fetal movement and variable heart rate may occur.
If the medicine is taken in late pregnancy or during labor, the child may experience muscle weakness, decreased body temperature, feeding difficulties, and breathing problems (respiratory failure).
If the medicine is taken regularly in late pregnancy, physical dependence may develop, and withdrawal symptoms, such as agitation or tremors, may occur. In such cases, the newborn should be closely monitored in the postpartum period.
Breastfeeding
If the patient is taking Zolsana, they should not breastfeed.

Driving and operating machinery

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

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

To minimize the risk of these events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, or working at heights.
The patient should not consume alcohol or psychoactive substances while taking Zolsana, as this may enhance the sedative effect.

Zolsana contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Zolsana contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Zolsana

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Zolsana is 10 mg per 24 hours. The doctor may prescribe a lower dose for some patients. Zolsana should be taken:

• in a single dose,
• directly before bedtime,
• with a liquid (e.g., a glass of water).

The patient must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased concentration.
The patient should not exceed the dose of 10 mg per 24 hours.

Adults

The usual dose is 10 mg (1 tablet).

Elderly or weakened patients

The initial dose is 5 mg (1/2 tablet).

Liver function disorders

The initial dose is 5 mg (1/2 tablet).

Children

Zolsana should not be taken by children and adolescents under 18 years of age, as there is no available data on its use in this age group.

Duration of treatment

The duration of treatment should be as short as possible and not exceed 4 weeks, including the period of gradual dose reduction, as the risk of misuse and dependence increases with the duration of treatment. The doctor will inform the patient about the duration of treatment, and in some cases, may extend it.

Taking a higher dose of Zolsana than prescribed

If the patient takes a higher dose of Zolsana than prescribed, they should immediately consult their doctor or pharmacist.
Overdose of Zolsana may cause a range of symptoms, from increased drowsiness to mild coma. In case of overdose or suspected overdose, the patient should immediatelyconsult their doctor.

Missing a dose of Zolsana

It may happen that the patient forgets to take Zolsana. In such cases, there is no need to take the missed dose. The patient should take the prescribed dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Zolsana

The patient should not suddenly stop taking Zolsana. Withdrawal symptoms, such as headache, muscle pain, severe anxiety and tension, restlessness, disorientation, and irritability, may occur. The patient should consult their doctor, who will gradually reduce the dose of the medicine to stop treatment.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Zolsana can cause side effects, although not everybody gets them.
The following side effects occur mainly in the initial treatment period: drowsiness during the day, feeling of numbness, reduced alertness, disorientation, fatigue, headache, dizziness, muscle weakness, coordination disorders (ataxia), and double vision. These effects usually disappear as treatment progresses. Other reported side effects include gastrointestinal disorders, changes in libido, and skin reactions.
Common side effects(may affect up to 1 in 10 people):

• upper and lower respiratory tract infections
• hallucinations, excitement, nightmares, worsening of sleep disorders, depression
• drowsiness during the day, feeling of numbness, headache, dizziness, memory loss, which may occur a few hours after taking the medicine (anterograde amnesia; the risk of its occurrence increases when the patient sleeps less than 7 or 8 hours)
• diarrhea, nausea, vomiting, abdominal pain
• back pain
• fatigue

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

• changes in appetite
• confusion, irritability, restlessness, outbursts of anger (aggression), sleepwalking, euphoric mood
• tingling, itching, or numbness without cause (paresthesia), involuntary trembling, attention disorders (concentration), speech disorders
• blurred vision, double vision
• increased liver enzyme activity
• rash, itching, excessive sweating
• joint pain, muscle pain, muscle cramps, neck pain, muscle weakness

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

• changes in libido
• reduced alertness, coordination disorders (ataxia)
• liver damage of various types
• rash with severe itching (urticaria) and lump formation, urticaria
• abnormal gait

Very rare side effects(may affect less than 1 in 10,000 people):

• limited vision
• delusions, physical and psychological dependence
• respiratory failure

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

• sudden accumulation of fluid in the skin and mucous membranes (e.g., in the throat or tongue), breathing difficulties, and/or itching and rash - often occurring as an allergic reaction (angioedema)
• outbursts of anger, unusual behavior, and psychosis, drug misuse
• addiction
• falls (especially in elderly people)

During treatment with the medicine, symptoms of existing depression may become apparent.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Zolsana

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date 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 the specified month.
The medicine should be stored in its original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Zolsana contains

• The active substance of the medicine is zolpidem tartrate. Each coated tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are: Core:lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, and magnesium stearate. Coating:Opadry Y-1-7000 White: titanium dioxide (E 171), hypromellose 5cP, and macrogol 400.

What Zolsana looks like and contents of the pack

The coated tablets are white, oval, biconvex, with a dividing line on both sides, and with "ZIM" and "10" embossed on one side. The tablet can be divided into equal doses.
Packaging:10, 20, and 30 coated tablets in blisters, in a carton box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Synthon Hispania S.L., Polígono Las Salinas, 08330 Sant Boi de Llobregat, Spain
Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands
Date of last revision of the leaflet:14.03.2019