Zolpeduar

Package leaflet: Information for the patient

Zolpeduar 5 mg sublingual tablets, 10 mg sublingual tablets

Zolpidem tartrate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zolpeduar is and what it is used for

Zolpeduar tablets are sleeping pills (hypnotics) that act on the brain, causing drowsiness. They can be used in adults for the short-term treatment of severe, disabling or distressing insomnia. Insomnia is difficulty in falling asleep or sleeping properly.

2. What you should know before taking Zolpeduar

Do not take Zolpeduar if:

• you are allergic to zolpidem tartrate or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue;
• you have severe liver problems;
• you suffer from sleep apnoea (a condition in which you stop breathing for brief periods while sleeping);
• you have severe muscle weakness (myasthenia gravis);
• you have acute and severe respiratory problems;
• you have previously experienced episodes of sleepwalking or other unusual behaviours during sleep such as driving, eating, making phone calls or having sexual intercourse, while not fully awake, after taking Zolpeduar or other medicines containing zolpidem.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zolpeduar if:

• you are elderly or frail. Be cautious when getting up at night. Zolpeduar may relax your muscles. This effect, together with its sedative effect, increases the risk of falls and consequently of hip fractures;
• you have any kidney or liver problems;
• you have a history of respiratory disorders. While taking Zolpeduar, your breathing may become weaker;
• you have a history of mental illness, anxiety or psychotic disorders. Zolpidem may unmask or worsen their symptoms;
• you have or have had heart problems or a condition called long QT syndrome;
• you suffer or have a history of depression (feeling of sadness) or have suicidal thoughts;
• you have, or have had, a history of alcoholism or drug addiction or a tendency to misuse substances. In these patients, the risk of dependence on Zolpeduar (physical or psychological effects caused by a compulsion to continue taking the medicine) increases even with dosage and duration of treatment.

Children and adolescents
Zolpeduar must not be used in children and adolescents under 18 years of age.
Next-day psychomotor impairment (see also “Driving and use of machines”)
The day after taking Zolpeduar, the risk of next-day psychomotor impairment, including impaired ability to drive, may increase if you:

• take this medicine less than 8 hours before performing activities requiring mental alertness;
• take a higher dose than recommended;
• take zolpidem while already taking other medicines with central nervous system depressant effects or other medicines that increase zolpidem levels in the blood, or while consuming alcohol or taking illicit substances. Take the single dose immediately before going to bed. Do not take another dose during the same night.

Other considerations

• Tolerance: If after a few weeks you notice that the tablets are no longer working as effectively as when you first started treatment, consult your doctor.
• Dependence: When taking this type of medicine, there is a risk of abuse and dependence, which increases with dose and duration of treatment. The risk is higher if you have a history of psychiatric disorders or drug, alcohol or substance abuse. However, dependence may also occur at doses normally used for treatment or if you do not show risk factors such as a history of alcohol or drug abuse.
• Discontinuation: Treatment should be stopped gradually. When you stop taking the medicine, a brief withdrawal syndrome may occur, in which the symptoms that led you to start treatment with Zolpeduar reappear in an intensified form. It may be accompanied by other reactions, including mood changes, anxiety and restlessness.
• Amnesia: Zolpeduar may cause memory loss. To reduce the risk, ensure you can sleep uninterrupted for 8 hours.
• Psychiatric reactions and “paradoxical” effects: Zolpeduar may cause unwanted behavioural effects such as restlessness, agitation, irritability, aggression, delirium (false beliefs), anger, nightmares, hallucinations, psychosis (hallucinations; when you see, hear or perceive things that do not exist), inappropriate behaviour and worsening of insomnia.
• Zolpeduar may induce sleepwalking and other unusual sleep-related behaviours while not fully awake (such as driving, eating, making phone calls or having sexual intercourse, etc.). The next morning, you may not remember having done anything during the night. If any of these events occur, stop treatment with Zolpeduar immediately and contact your doctor, as these sleep behaviours could place you and others at serious risk of injury.
• Alcohol and certain medicines used to treat depression or anxiety, or using Zolpeduar at doses exceeding the maximum recommended dose, may increase the risk of these adverse effects.
• Risk of falls and serious injuries – Zolpeduar may cause drowsiness and reduced level of consciousness, which may increase the risk of falls and consequently of serious injuries (see also section 4 “Possible side effects”).

Other medicines and Zolpeduar
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Zolpeduar may affect the effect and/or side effects of other medicines. If you are about to undergo surgery under general anaesthesia, inform your doctor about all medicines you are taking.
When taking zolpidem together with the following medicines, increased effects of drowsiness and next-day psychomotor impairment, including impaired ability to drive, may occur:

• medicines for certain mental health conditions (antipsychotics);
• medicines for insomnia (hypnotics);
• medicines to calm or reduce anxiety;
• medicines for depression;
• medicines for moderate to severe pain (narcotic analgesics);
• medicines for epilepsy;
• medicines used for anaesthesia;
• medicines for hay fever, skin rashes (rash) or other allergies that may cause drowsiness (sedating antihistamines);
• muscle relaxants;
• medicines that inhibit liver enzymes. Ask your doctor or pharmacist which medicines have this effect (e.g., ketoconazole, a medicine used to treat fungal infections).

When taking zolpidem together with antidepressants, including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not there (hallucinations).
Concomitant use of Zolpeduar and opioids (strong analgesics, medicines for addiction therapy and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Zolpeduar together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.
Taking zolpidem with fluvoxamine or ciprofloxacin is not recommended.
Zolpeduar may increase the effect of muscle-relaxing medicines. Therefore, the risk of falls may be increased, especially in elderly patients and at higher doses.
Rifampicin (a medicine used to treat tuberculosis), carbamazepine (a medicine used, for example, for epilepsy), phenytoin (a medicine used, for example, for epilepsy) and St. John’s wort [(Hypericum perforatum), a herbal traditional medicine] may reduce the effect of Zolpeduar. Therefore, concomitant use is not recommended.

Zolpeduar with food, drinks and alcohol
During treatment with Zolpeduar, you must not consume alcohol, as it may increase the sedative effect.
Grapefruit juice may affect the effect of this medicine; speak with your doctor for further information.

Pregnancy and breastfeeding
Pregnancy
Zolpeduar must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
If Zolpeduar is used during pregnancy, there is a risk that the baby may be harmed. Some studies have shown that the risk of cleft lip and/or palate (sometimes called “harelip”) may be increased in the newborn. Reduced fetal movement and variability in fetal heart rate may occur after taking zolpidem during the second and/or third trimester of pregnancy.
If you take Zolpeduar at the end of pregnancy or during labour, the baby may experience muscle weakness, low body temperature, feeding and breathing difficulties (respiratory problems).
If this medicine is taken regularly in the late stages of pregnancy, the baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored in the period immediately after birth.

Breastfeeding
Do not breastfeed your baby, as zolpidem may pass into breast milk.

Driving and use of machines
Zolpeduar impairs your ability to drive vehicles and operate machinery, for example due to the risk of "falling asleep at the wheel".
The day after taking Zolpeduar (as with other hypnotic medicines), you should be aware that:

• you may feel drowsy, sleepy, dizzy or confused;
• it may take you longer to make decisions;
• your vision may be blurred or double;
• you may feel less alert. A period of at least 8 hours is recommended between taking zolpidem and driving, operating machinery or working at heights, to minimise the effects listed above.

Do not drink alcohol or take other psychoactive substances while taking Zolpeduar, as the effects listed above may be intensified.

Zolpeduar contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Zolpeduar

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The tablet must be placed under the tongue and allowed to dissolve. Since the tablet acts rapidly, take Zolpeduar immediately before going to bed or when you are already in bed. Do not take Zolpeduar during or immediately after a meal.
Adults:
The recommended dose every 24 hours is 10 mg of Zolpeduar. A lower dose may be prescribed for some patients. Zolpeduar should be taken:

• as a single dose,
• immediately before bedtime. Make sure you have at least 8 hours of uninterrupted sleep after taking this medicine before engaging in any activities requiring your full attention. Do not exceed 10 mg every 24 hours.

Elderly patients (over 65 years) or debilitated patients: The recommended dose is 5 mg. The recommended dose must not be exceeded.
Patients with liver problems: The usual starting dose is 5 mg. Your doctor may decide to increase it to 10 mg if considered appropriate.
Do not take Zolpeduar if you have severe liver problems.
Patients with respiratory problems: A lower dose is recommended for patients with respiratory problems.
Use in children and adolescents: Zolpeduar must not be used in children and adolescents under 18 years of age.
If after a few weeks you notice that the tablets are not working as effectively as they did when you first started treatment, consult your doctor, as a dosage adjustment may be necessary.
Duration of treatment
The treatment duration should be as short as possible. The maximum treatment period, including the gradual discontinuation process, is four weeks.
Your doctor will choose the most appropriate gradual discontinuation regimen for you, based on your individual needs.
In some situations, you may need to take Zolpeduar for longer than four weeks. If this is the case, your doctor must re-evaluate your condition and treatment, as the risk of abuse and dependence increases with the duration of treatment.
If you take more Zolpeduar than you should
If you (or someone else) ingest a large number of tablets at once, or if you suspect that a child has swallowed any tablet, contact your doctor or the nearest emergency department immediately. Take the packaging and any remaining tablets with you. Do not go for medical help alone.
The following symptoms may occur:

• Feeling of weakness, drowsiness, possible risk of falling into coma and other disturbances that may lead to death.

If you forget to take Zolpeduar
If you forget to take a dose just before going to bed but remember during the night, take the missed dose only if you can still sleep for 8 uninterrupted hours. If this is not possible, take the next dose the following night, before going to bed. Do not take a double dose to make up for the missed dose. If you are concerned, consult your pharmacist or doctor for advice.
If you stop taking Zolpeduar
Treatment must be stopped gradually; otherwise, the symptoms being treated may return with greater intensity than before (rebound insomnia). Anxiety, restlessness, and mood changes may also occur. These effects will disappear over time.
If you have become physically dependent on Zolpeduar, abruptly stopping treatment will cause unwanted effects such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, and insomnia. In severe cases, other effects may occur, such as hypersensitivity to light, noise, and physical touch, abnormally acute hearing and painful sensitivity to sound, hallucinations, numbness and tingling in the extremities, derealization (perceiving the world around you as unreal), depersonalization (feeling detached from your own body), or epileptic seizures (violent convulsions or tremors). These symptoms may also occur between doses, especially if the dose is high.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Zolpeduar and inform your
doctor immediately or go to the nearest emergency room:

• allergic reactions such as skin rash or itching, accompanied by swelling of the face, lips, throat or tongue and difficulty breathing or swallowing (angioedema).

These side effects are serious, but their frequency is unknown (cannot be estimated from
the available data). You need immediate medical attention.
Tell your doctor or pharmacist if you notice the onset or worsening of any of the following
side effects:
Common side effects (may affect up to 1 in 10 people):

• respiratory infections
• hallucinations, agitation, nightmares, emotional blunting, depression (sadness)
• drowsiness, headache, dizziness, increased insomnia, cognitive disturbances such as amnesia (which may be associated with inappropriate behaviour), daytime drowsiness
• sensation of dizziness
• double vision
• diarrhoea, nausea, vomiting, abdominal pain
• skin reactions
• fatigue
• back pain

The risk of amnesia is higher at higher doses. If you are sure you can sleep uninterrupted for
8 hours, the risk of amnesia is reduced.
Uncommon side effects (may affect up to 1 in 100 people):

• confusion, irritability, restlessness, aggression
• coordination disorders, tingling or numbness, tremors, muscle weakness, muscle pain, muscle spasms, joint pain, neck pain
• blurred vision
• skin rashes, itching, excessive sweating
• loss of appetite
• sleepwalking (see section 2 ‘Other considerations – sleepwalking and other associated behaviours’)
• reduced attention
• speech disorders
• euphoric mood
• increased levels of certain liver enzymes (which would be detected by your doctor during a blood test)

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

• urticaria
• changes in sexual desire (libido)
• reduced level of consciousness
• gait disturbances
• falls, especially in elderly patients
• visual disturbances
• liver damage
• paradoxical reactions (restlessness, agitation, irritability, aggression, delusions (false beliefs), rage, nightmares, hallucinations, psychosis, inappropriate behaviour and other adverse behavioural effects). These effects occur more frequently in elderly patients.

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

• decreased respiratory function (respiratory depression)

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

• delirium (false beliefs), rage, psychosis (hallucinations; when you see, hear or feel things that do not exist), inappropriate behaviour
• physical dependence: use (even at therapeutic doses) may lead to physical dependence; abrupt discontinuation of treatment may cause withdrawal symptoms and recurrence of problems
• psychological dependence: this occurs when you believe you cannot sleep without taking Zolpeduar
• need to take increasingly higher doses of a medicine to achieve the same effect

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zolpeduar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zolpeduar contains
The active substance is zolpidem tartrate.
Zolpeduar 5 mg:
Each sublingual tablet contains 5 mg of zolpidem tartrate.
Zolpeduar 10 mg:
Each sublingual tablet contains 10 mg of zolpidem tartrate.
The other components are mannitol (E421), silicified microcrystalline cellulose (a mixture of microcrystalline cellulose and anhydrous colloidal silica), anhydrous colloidal silica, sodium croscarmellose, sodium saccharin, magnesium stearate.

Description of the appearance of Zolpeduar and contents of the pack
Zolpeduar 5 mg:
The medicine is presented as white, round, flat tablets with bevelled edges, approximately 7.5 mm in diameter, with an engraved "V" on one side.
Zolpeduar 10 mg:
The medicine is presented as white, round, flat tablets with bevelled edges, approximately 7.5 mm in diameter, with an engraved "X" on one side.
The medicine is available in blister packs containing 10, 14, 20, 28, 30, 60, 100 and 150 sublingual tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Viatris Italia S.r.l.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturer
Mylan Hungary Kft.
Mylan utca 1
2900 Komárom
Hungary

This medicinal product is authorized in the European Economic Area countries
under the following names:
Austria, Bulgaria, Denmark, Finland, France, Hungary, Iceland, Ireland, Netherlands, Portugal, Romania, Slovenia, Spain, Sweden, Northern Ireland: Edluar
Belgium, Italy, Luxembourg: Zolpeduar