Sonrest

Package Leaflet: Information for the User

Sonrest, 7.5 mg, coated tablets

Zopiclone

Read the package 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, pharmacist, or nurse.
• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Sonrest and what is it used for

Sonrest contains the active substance zopiclone, which belongs to a group of medicines called hypnotics and anxiolytics, similar to benzodiazepines.
Sonrest is used for the short-term treatment of insomnia in adults.
It works by increasing the duration of sleep and reducing the number of awakenings during the night.
Sonrest will only be prescribed if your insomnia is severe, disabling, or causing you significant distress.

2. Before you take Sonrest

When not to take Sonrest:

• if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6);
• if you have severe breathing difficulties (severe respiratory insufficiency),
• if you have sleep apnoea syndrome (a condition where you stop breathing for short periods during sleep);
• if you have severe liver disease;
• if you have myasthenia gravis (a condition where your muscles are weak);
• if you have ever had a condition where you walk or do things while you are asleep (such as sleep walking or driving), or other unusual behaviours while you are asleep, after taking zopiclone or other similar medicines.

Warnings and precautions

General
Before taking Sonrest, discuss your treatment with your doctor or pharmacist.
Before starting treatment with Sonrest, your doctor should investigate the reason for your sleep problems and treat any other conditions that may be contributing to them.
Tell your doctor if you have ever had any of the following conditions or if you are currently suffering from them, especially:

• liver or kidney problems;
• breathing difficulties;
• general weakness;
• you are elderly (the elderly may be more sensitive to the effects of the medicine);
• depression or anxiety associated with depression;
• a history of alcohol, drug, or medicine abuse;
• you have recently taken Sonrest or other similar medicines for more than 4 weeks.

Your doctor will decide whether you should take Sonrest and, if so, what dose to take. During treatment, your doctor will carefully monitor you.
Dependence and withdrawal symptoms
Taking medicines like Sonrest can lead to physical or psychological dependence or abuse. The risk of dependence increases with the dose and duration of treatment. This risk is also higher in patients who have a history of alcohol, drug, or medicine abuse and (or) have marked personality disorders.
If physical dependence occurs, stopping treatment suddenly can lead to withdrawal symptoms such as insomnia, headache, muscle pain, increased anxiety, tension, restlessness, confusion (disorientation), and irritability.
In severe cases, the following symptoms may occur: depersonalization (loss of personal identity, followed by feelings of unreality and strangeness), derealization (altered perception of the world, making it seem strange or unreal), increased sensitivity to sound, numbness or tingling of limbs, increased sensitivity to light, noise, or physical contact, seeing, hearing, or feeling things that are not there (hallucinations), and seizures (fits).
Rebound insomnia after stopping treatment (rebound insomnia)
Stopping treatment with Sonrest after taking it for a long time can lead to rebound insomnia, which can last for several nights.
This is a temporary condition known as "rebound insomnia". To avoid withdrawal symptoms after long-term treatment, it is recommended to gradually reduce the dose. See also section 4 "Possible side effects".
Tolerance
Tolerance to Sonrest may develop if the medicine is taken repeatedly for several weeks. This is known as tolerance. If you think the effect of Sonrest is weakening, consult your doctor.
Anterograde amnesia (short-term memory loss)
Sonrest can cause short-term memory loss, especially a few hours after taking the tablet. To minimize the risk of this, patients should take Sonrest immediately before going to bed or in bed and ensure they have an uninterrupted sleep of 7-8 hours.
Psychological and "paradoxical" reactions
During treatment with Sonrest, the following psychological reactions may occur: anxiety and restlessness, nightmares, irritability, aggression, inappropriate behaviour, hallucinations (seeing or hearing things that are not there), confusion, and concentration difficulties.
Somnambulism (sleep walking) and related behaviours
Sleep walking and other related behaviours, such as "sleep driving", preparing and eating food, or making phone calls while asleep, with no memory of the event, have been reported in patients taking zopiclone and not being fully awake.
The risk of such behaviour increases if Sonrest is taken with alcohol or certain other medicines (e.g., opioid painkillers, antipsychotics, sedatives, or anxiolytics).
The risk also increases if Sonrest is taken in doses higher than the recommended maximum dose.
If any of the above symptoms occur, contact your doctor immediately.
Depression/suicidal thoughts
This medicine is not intended for the treatment of depression. If you are depressed, your doctor will prescribe appropriate treatment. If depression is not treated, it may worsen, become chronic, or increase the potential risk of suicide.
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it is not known whether this is caused by the medicine or other factors. If you have suicidal thoughts, contact your doctor as soon as possible for medical advice.
Risk of falls
Due to the muscle relaxant effect of zopiclone, there is a risk of falls, especially in elderly patients who get up at night.

Children and adolescents

Sonrest should not be used in children and adolescents under 18 years of age. The safety and efficacy of zopiclone in children and adolescents under 18 years of age have not been established.

Sonrest and other medicines

Taking other medicines with Sonrest may affect its efficacy and may require dose adjustment of Sonrest.
Tell your doctor about all medicines you are currently taking or have recently taken, and about any medicines you plan to take. In particular, about taking any of the following medicines:
­
medicines for certain mental disorders (antipsychotics/neuroleptics)
­
sleeping pills (hypnotics)
­
medicines for anxiety (anxiolytics)
­
medicines for sedation (sedatives)
­
medicines for depression (antidepressants)
­
strong painkillers from the opioid group, e.g., morphine and morphine-like substances
­
medicines used in surgery (anaesthetics)
­
medicines used to treat allergies (antihistamines)
­
certain medicines used to treat bacterial and fungal infections, such as erythromycin or itraconazole
­
medicines used to treat HIV (human immunodeficiency virus) infection
­
medicines used to treat epilepsy, such as phenytoin, phenobarbital, and carbamazepine
­
medicines used to treat tuberculosis (e.g., rifampicin)
­
medicines containing St. John's Wort (a traditional herbal medicine).
Taking Sonrest and opioids (strong painkillers, substitution treatment, and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, taking them together should only be considered when other treatment options are not possible.
If your doctor prescribes Sonrest with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
Tell your doctor about all opioid medicines you are taking and follow your doctor's dosage instructions carefully. It may be helpful to inform friends or family members about the risk so they can be aware of the signs and symptoms. If such symptoms occur, contact your doctor.

Sonrest with food and alcohol

Do not drink alcohol while taking Sonrest, as alcohol may enhance the effects of Sonrest.
While taking Sonrest, avoid consuming grapefruits and grapefruit juice.
Grapefruit may enhance the effects of Sonrest.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Sonrest should not be used during pregnancy, as it passes through the placenta.
If used during pregnancy, there is a risk of effects on the baby. Some studies have shown an increased risk of cleft lip and palate in newborns.
There may be reduced fetal movement and variable fetal heart rate if the mother takes Sonrest in the second and/or third trimester of pregnancy.
If a patient takes Sonrest at the end of pregnancy or during delivery, the baby may show weakness, low body temperature, difficulty sucking, and breathing difficulties (respiratory depression).
If a patient regularly takes Sonrest in late pregnancy, the baby may develop physical dependence and experience withdrawal symptoms such as agitation or tremors. In such cases, the newborn should be closely monitored during the postnatal period.
If a newborn shows any of the above symptoms at birth or after birth, contact your doctor and/or midwife.
Breastfeeding
This medicine passes into breast milk. Sonrest should not be used during breastfeeding.

Driving and using machines

Zopiclone can significantly affect your ability to drive and use machines.
Like other hypnotics, zopiclone can cause drowsiness, prolonged reaction time, dizziness, confusion (lack of reaction), blurred or double vision, reduced concentration, and impaired ability to drive, especially within the first 12 hours after taking zopiclone (see section 4 "Possible side effects").
Impaired driving ability and behaviour such as falling asleep at the wheel may occur when zopiclone is taken as a single dose, at the recommended dose.
Do not drive or operate machinery until you have stopped taking Sonrest or until your doctor has confirmed that your ability to drive or operate machinery is not impaired. These effects may persist until the next day.
Do not take alcohol or other medicines that act on the central nervous system (sedatives, sleeping pills, certain cough medicines, etc.) with Sonrest, as this may enhance the side effects (see section 2 "Warnings and precautions", "Sonrest and other medicines").

Sonrest contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sonrest contains sodium

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

3. How to take Sonrest

Dose
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
In all cases, your doctor will try to find the lowest effective dose for you.
Do not take another dose during the same night.
For adults and patients under 65 years, the recommended dose is 7.5 mg per day, taken before bedtime.
For patients over 65 years, the recommended dose is 3.75 mg per day, taken before bedtime.
For patients with chronic respiratory insufficiency, liver or kidney problems, the recommended dose is 3.75 mg per day, taken before bedtime.
If you feel that the effect of Sonrest is weakening over time, do not increase the dose, consult your doctor.
Use in children and adolescents
Sonrest should not be used in children and adolescents under 18 years of age, as the safety and efficacy of Sonrest in this age group have not been established.
Method of administration
Take the medicine by mouth.
Swallow the tablet with a glass of water.
The score line on the tablet indicates that it can be divided into two equal doses if necessary.
Frequency of administration
Take a single dose of Sonrest immediately before going to bed or in bed.
Ensure you have an uninterrupted sleep of 7-8 hours. This will minimize the risk of anterograde amnesia (short-term memory loss) and difficulties in coordinating certain movements (psychomotor function disorders).
Duration of treatment:
Treatment should be as short as possible, not exceeding 4 weeks, including the period of gradual dose reduction.
If insomnia persists, consult your doctor.

Taking a higher dose of Sonrest than recommended

If you take more Sonrest than you should, contact your doctor, pharmacist, or go to the hospital emergency department immediately, as an overdose can be dangerous.
Overdose symptoms may include:
­
drowsiness, disorientation, lethargy
­
falling or loss of balance (ataxia)
­
muscle weakness (hypotonia)
­
dizziness, feeling of fainting (due to low blood pressure)
­
shallow and slow breathing (respiratory depression)
­
coma.

Missing a dose of Sonrest

If you forget to take Sonrest, but you can still sleep for 7-8 hours, take the missed dose immediately.
If the time you have available for sleep is shorter, skip the missed dose and do not take another dose until the next day, at the usual time, if needed. Never take a double dose to make up for a forgotten tablet.

Stopping treatment with Sonrest

Suddenly stopping treatment with Sonrest may cause rebound insomnia. Withdrawal symptoms may also occur, including difficulty sleeping, headaches, sweating, hallucinations, and rapid heartbeat. In severe cases, seizures (fits) may occur. The risk of withdrawal symptoms increases with the dose and duration of treatment, so your doctor may advise you on gradual dose reduction.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sonrest can cause side effects, although not everybody gets them.
They may vary depending on the dose used and individual patient sensitivity.
Stop takingSonrest and contact your doctor immediatelyif you experience any of the following symptoms ( very rare, may affect up to 1 in 10,000 people):

• swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing (angioedema).
• symptoms of a severe allergic reaction: itching rash, swelling of the mouth, which can cause difficulty breathing and swallowing, wheezing (anaphylactic reaction).

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

• impaired concentration or drowsiness (especially in elderly patients)
• bitter taste in the mouth or other taste disturbances
• dry mouth

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

• restlessness, nightmares
• dizziness, headache
• nausea
• fatigue

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

• confusion, libido disorders, irritability, aggression, hallucinations (seeing or hearing things that are not there)
• memory loss for events that occurred during treatment (anterograde amnesia). This effect may occur at prescribed doses. The risk increases in proportion to the dose.
• breathing difficulties (dyspnoea)
• rash, itching, red itchy patches on the skin (urticaria)
• falling risk (especially in elderly patients)

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

• increased liver enzyme activity (transaminases and/or alkaline phosphatase in the blood), liver disease (hepatitis)

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

• behavioural disorders
• delirium (sudden and severe change in mental state, which can cause confusion, disorientation, and/or attention deficit), false beliefs (delusions)
• fits of rage, nervousness
• sleep walking or other unusual behaviours during sleep (such as driving, eating, telephoning, or having sex, etc.) while not being fully awake (see section 2 "Warnings and precautions")
• physical and psychological dependence, even at prescribed doses, with a withdrawal syndrome or rebound insomnia after stopping treatment (see section 2 "Dependence and withdrawal symptoms" and "Rebound insomnia after stopping treatment")
• disorientation, insomnia, tension
• depression
• ataxia (coordination disorders), numbness or tingling of limbs (paresthesia), cognitive disorders, such as memory disorders, attention disorders, speech disorders
• respiratory depression (slow and shallow breathing)
• double vision
• nausea, vomiting
• reduced muscle strength (hypotonia)

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Drug Monitoring of the 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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sonrest

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 after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sonrest contains

• The active substance is zopiclone. Each coated tablet contains 7.5 mg of zopiclone.
• Other ingredients:
• Core:calcium hydrogen phosphate dihydrate; lactose monohydrate(see section 2 "Sonrest contains lactose"); sodium carboxymethylcellulose (type A)(see section 2 "Sonrest contains sodium"); maize starch; magnesium stearate.
• Coating:" Opadry Blue" coating: hypromellose 2910 (E464); talc (E553b); titanium dioxide (E171); propylene glycol (E1520); brilliant blue FCF "aluminium lake" (E133).

What Sonrest looks like and contents of the pack

Blue, oval, biconvex, coated tablets with a score line on one side and "Z" and "1" on either side of the score line on one side and plain on the other side.
The tablet can be divided into two equal doses.
Aluminium/PVC/PVDC blister pack containing 10 coated tablets.
10, 20, or 30 coated tablets (1, 2, or 3 blisters) with a leaflet in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
Email: Olpha.poland.pv@insuvia.com

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

Czech Republic, Denmark, Estonia, Italy, Norway, Sweden, Slovakia: Zopiclone Olpha
Lithuania: Zopiclone Olpha 7,5 mg plėvele dengtos tabletės
Latvia: Zopiclone Olpha 7,5 mg apvalkotās tabletes
Poland: Sonrest
Germany: Zopiclon Olpha

Date of last revision of the leaflet: