Sonrest

Leaflet accompanying the packaging: information for the user

Sonrest, 3.75 mg, coated tablets

Zopiclone

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 your doctor, pharmacist, or nurse.
• 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sonrest and what is it used for
• 2. Important information before taking Sonrest
• 3. How to take Sonrest
• 4. Possible side effects
• 5. How to store Sonrest
• 6. Contents of the packaging 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 prolonging sleep time and reducing the number of awakenings during the night.
Sonrest will only be prescribed in cases of severe sleep disorders that impair functioning or cause significant exhaustion in the patient.

2. Important information before taking Sonrest

When not to take Sonrest:

• if the patient is allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe breathing difficulties (severe respiratory failure),
• if the patient has sleep apnea syndrome (a disorder characterized by pauses in breathing during sleep);
• if the patient has severe liver disease;
• if the patient has significant muscle weakness called myasthenia (an autoimmune disease);
• if the patient has experienced sleepwalking or other unusual behaviors (such as driving, eating, talking on the phone, or having sex, etc.) while not fully awake after taking Sonrest or other medicines containing zopiclone.

Warnings and precautions

General
Before starting to take Sonrest, discuss it with your doctor or pharmacist.
Before starting treatment with Sonrest, the cause of sleep problems should be investigated and any other underlying diseases should be treated.
The patient should inform their doctor if they have or have had any of the following conditions or diseases, especially:

• liver or kidney function disorders;
• breathing disorders;
• worsening of overall health;
• the patient is elderly (in older people, medicines stay in the body longer);
• depression or anxiety associated with depression;
• alcohol, drug, or medicine abuse in the past;
• the patient has recently taken Sonrest or other similar medicines for a period longer than 4 weeks.

The doctor will decide whether the patient should take Sonrest or not, or whether the dose of the medicine should be adjusted.
During treatment, the doctor should carefully monitor the patient.
Dependence and withdrawal symptoms
Taking medicines like Sonrest can lead to physical or psychological dependence or abuse of these medicines. The risk of dependence increases with the dose and duration of treatment. This risk is also higher in patients who have abused alcohol, drugs, or medicines in the past and (or) have significant personality disorders.
If physical dependence occurs, sudden cessation of treatment may 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: derealization (a change in the perception of the world, so that it seems strange or unreal), depersonalization (loss of personal identity, followed by a feeling of unreality and strangeness), hypersensitivity to sound, numbness and tingling of limbs, hypersensitivity to light, noise, or physical contact, seeing, hearing, or feeling things that do not actually exist (hallucinations), and seizures.
Rebound insomnia after treatment discontinuation (rebound insomnia)
Sudden cessation of Sonrest after longer treatment may cause rebound insomnia lasting several nights.
This is a transient condition called "rebound insomnia". To avoid withdrawal symptoms after longer treatment, it is recommended to gradually reduce the dose.
See also the section on side effects.
Tolerance
Decreased efficacy of Sonrest may occur if the medicine is used repeatedly for several weeks. This phenomenon is called tolerance. The patient should consult their doctor if they feel that the effect of Sonrest is decreasing.
Short-term memory loss, so-called anterograde amnesia
Sonrest may cause short-term memory loss, especially a few hours after taking the tablet. To minimize the risk of this phenomenon, patients should take Sonrest immediately before going to bed or in bed and ensure uninterrupted sleep for 7-8 hours.
Psychological reactions and "paradoxical"
During treatment with Sonrest, the following psychological reactions may occur: anxiety and anxiety, nightmares, irritability, aggression, inappropriate behavior, hallucinations (seeing and hearing things that do not exist), confusion, and difficulty concentrating.
Sleepwalking, so-called somnambulism, and related behaviors
Sleepwalking and other related behaviors, such as "sleep driving", preparing and eating food, or making phone calls while asleep, with loss of memory of the activity performed, have been reported in patients taking zopiclone and not being fully awake.
The risk of such behavior increases if Sonrest is taken with alcohol or certain other specified medicines (e.g., opioid painkillers, antipsychotics, sedatives, or anxiolytics).
The risk also increases if Sonrest is taken in doses exceeding the maximum recommended dose.
In case of any of the above symptoms, the patient should immediately contact their doctor.
Depression/suicidal thoughts
This medicine is not intended for the treatment of depression. If depression occurs, the doctor will prescribe appropriate treatment. If depression remains untreated, it may worsen, become chronic, or increase the potential risk of suicide.
Some studies have shown an increased risk of suicidal thoughts, attempted suicide, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is due to the action of the medicine or other causes. If the patient has suicidal thoughts, they should contact their doctor as soon as possible to receive 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 action and may require dose adjustment of Sonrest.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, about taking any of the following medicines:
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medicines for certain mental disorders (antipsychotics/neuroleptics)
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sleeping pills (hypnotics)
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medicines used to treat anxiety (anxiolytics)
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medicines used to calm (sedatives)
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medicines used to treat depression (antidepressants)
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strong painkillers from the opioid group, e.g., morphine and morphine-like substances
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medicines used in surgery (anesthetics)
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medicines used to treat allergies (antihistamines)
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certain medicines used to treat bacterial and fungal infections, such as erythromycin or itraconazole
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medicines used to treat HIV infection (human immunodeficiency virus)
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medicines used to treat epilepsy, such as phenytoin, phenobarbital, and carbamazepine
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medicines used to treat tuberculosis (e.g., rifampicin)
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medicines containing St. John's wort (a traditional herbal remedy).
Concomitant use of Sonrest and opioids (strong painkillers, substitution therapy, and some cough medicines) increases the risk of sedation, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes Sonrest with opioids, the dose and duration of concomitant treatment should be limited by the doctor.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the doctor's instructions for dosing. It may be helpful to inform friends or family about the risk, so they are aware of the signs and symptoms mentioned above. In case of such symptoms, the patient should contact their doctor.

Sonrest with food and alcohol

While taking Sonrest, the patient should not consume alcohol, as alcohol may enhance the effect of Sonrest.
While taking Sonrest, the patient should avoid consuming grapefruits and grapefruit juice.
Grapefruit may enhance the effect of Sonrest.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist 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 disorders in the child. Some studies have shown that there may be an increased risk of cleft lip and palate in newborns.
There may be reduced fetal movement and variable heart rate in the fetus if the mother takes Sonrest in the second and/or third trimester of pregnancy.
If the patient takes Sonrest at the end of pregnancy or during delivery, their child may exhibit muscle weakness, low body temperature, difficulty sucking, and breathing difficulties (respiratory depression).
If the patient regularly takes Sonrest in late pregnancy, the child may develop physical dependence, and withdrawal symptoms may occur, such as agitation or tremors. In such cases, the newborn should be closely monitored in the postnatal period.
If the newborn exhibits any of the above symptoms at birth or after birth, the patient should contact their doctor and/or midwife.
Breastfeeding
This medicine passes into breast milk. Sonrest should not be used during breastfeeding.

Driving and using machines

Zopiclone may significantly affect the ability to drive and use machines.
Like other hypnotics, zopiclone may cause drowsiness, prolonged reaction time, dizziness, dullness (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 ability to drive and behaviors such as falling asleep at the wheel may occur when zopiclone is used as a single medicine, in recommended doses.
The patient should not drive or use machines until the end of treatment with Sonrest or until it is determined that their ability is not impaired. These effects may persist until the next day.
The patient should 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 the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Sonrest contains sodium

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

3. How to take Sonrest

Dose
This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
In all cases, the doctor will try to find the lowest effective dose.
The patient should not take another dose during the same night.
In adults and patients under 65 years of age, the recommended dose is 7.5 mg per day, taken before bedtime.
In patients over 65 years of age, the recommended dose is 3.75 mg per day, taken before bedtime.
In patients with chronic respiratory failure, liver or kidney disorders, the recommended dose is 3.75 mg per day, taken before bedtime.
If the patient feels that the effect of Sonrest has decreased over time, they should not increase the dose; instead, they should consult their 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
The medicine should be taken orally.
The tablet should be swallowed with a glass of water.
Frequency of administration
The patient should take a single dose of Sonrest immediately before going to bed or in bed.
The patient should ensure uninterrupted sleep for 7-8 hours. This will reduce the risk of memory loss (anterograde amnesia) and difficulties in coordinating certain movements (psychomotor function disorders).
Duration of treatment:
Treatment should be as short as possible, not longer than 4 weeks, including the period of gradual dose reduction.
In case of persistent insomnia, the patient should consult their doctor.

Taking a higher dose of Sonrest than recommended

In case of taking a higher dose of Sonrest than recommended, the patient should immediately contact their doctor, pharmacist, or go to the hospital emergency department, as an overdose can be dangerous.
Overdose symptoms may include:
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drowsiness, disorientation, lethargy
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fall or loss of balance (ataxia)
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muscle weakness (hypotonia)
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dizziness, feeling of fainting or fainting (due to low blood pressure)
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shallow and slow breathing (respiratory depression)
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coma.

Missing a dose of Sonrest

If the patient has forgotten to take the medicine, but still can sleep for 7-8 hours, they should take the medicine immediately.
If the time they can devote to sleep is shorter, they should skip this dose and not take another dose of the medicine until the next day, before bedtime, if necessary, at the usual time. The patient should never take a double dose to make up for a missed tablet.

Stopping treatment with Sonrest

Sudden cessation of Sonrest may cause transient sleep problems. Withdrawal symptoms may also occur, including difficulty falling asleep, headaches, excessive sweating, hallucinations, and rapid heartbeat. In severe and very rare cases, seizures (convulsions) may occur. The risk of withdrawal symptoms increases with the dose and duration of treatment, so the doctor may provide information on gradual dose reduction.
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, Sonrest can cause side effects, although not everybody gets them.
They may vary depending on the dose used and individual patient sensitivity.
The patient should stop takingSonrest and immediatelyconsult their doctor or go to the nearest emergency department if they experience the following symptoms (very rare, may occur in fewer than 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 occur in up to 1 in 10 people):

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

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

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

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

• confusion, libido disorders, irritability, aggression, inappropriate behavior, hallucinations
• memory loss of events that occurred during treatment (anterograde amnesia). This effect may occur at prescribed doses. The risk increases proportionally with the dose.
• breathing difficulties (dyspnea)
• rash, itching, itching red spots on the skin (urticaria)
• risk of falls (especially in elderly patients)

Very rare (may occur in fewer than 1 in 10,000 people):

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

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

• behavioral disorders
• delirium (sudden and severe change in mental state, which can cause a combination of confusion, disorientation, and/or attention deficit), false beliefs (delusions)
• fits of rage, nervousness
• sleepwalking or other unusual behaviors during sleep (such as driving, eating, talking on the phone, or having sex, etc.) while not fully awake (see section 2, "Warnings and precautions")
• physical and psychological dependence, even at doses prescribed by the doctor, with a withdrawal syndrome or rebound insomnia after treatment discontinuation (see section 2, "Dependence and withdrawal symptoms" and "Rebound insomnia after treatment discontinuation")
• 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 the patient experiences any side effects, including those not listed in this leaflet, they 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, 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, more information can be collected on the safety of the medicine.

5. How to store Sonrest

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 packaging and other information

What Sonrest contains

• The active substance of Sonrest is zopiclone. Each coated tablet contains 3.75 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"); cornstarch; magnesium stearate. ­ Coating:"Opadry Orange" colorant: talc (E553b); hypromellose 2910 (E464); titanium dioxide (E171); propylene glycol (E1520); yellow iron oxide (E172); red iron oxide (E172).

What Sonrest looks like and contents of the pack

Coated tablets of light orange to orange color, round, biconvex, with "Z2" embossing on one side and smooth on the other.
Aluminum/PVC/PVDC blister pack containing 10 coated tablets.
20 coated tablets (2 blisters) with a leaflet in a cardboard box.

Marketing authorization holder and manufacturer

Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
Email: [email protected]

This medicine is authorized for use 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 3.75 mg coated tablets
Latvia: Zopiclone Olpha 3.75 mg coated tablets
Poland: Sonrest
Germany: Zopiclon Olpha

Date of last revision of the leaflet: