ONIREX 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Onirex, 10 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Onirex and what is it used for
4. Important information before taking Onirex
   1. When not to take Onirex
   2. Warnings and precautions General
   3. Onirex and other medicines
   4. Pregnancy, breastfeeding, and fertility Pregnancy
   5. Driving and operating machinery
   6. Onirex contains lactose
   7. Onirex contains sodium
5. How to take Onirex
   1. Adults
   2. Elderly or debilitated patients
   3. Liver function disorders
   4. Kidney function disorders
   5. Use in children
   6. Method of administration
   7. Duration of treatment
   8. Overdose of Onirex
   9. Missed dose of Onirex
   10. Stopping Onirex
   11. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.
6. Possible side effects
   1. Reporting side effects
7. How to store Onirex
8. Contents of the pack and other information
   1. What Onirex contains
   2. What Onirex looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Onirex, 10 mg, coated tablets

Zolpidem tartrate

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.
In case of 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Onirex and what is it used for

Onirex belongs to a group of medicines with an action similar to benzodiazepines, used in the treatment of sleep disorders.
Onirex has a sedative and sleep-inducing effect. This reduces the time to fall asleep, decreases the number of nighttime awakenings, and prolongs the duration of deep sleep.
Onirex is used for the short-term treatment of insomnia in adults, only in cases of severe sleep disorders that interfere with normal functioning or are extremely bothersome to the patient.
The medicine should not be used for a long time. Treatment should be as short as possible, as the risk of dependence increases with the duration of treatment.

2. Important information before taking Onirex

When not to take Onirex

• If the patient is allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6).
• If the patient has muscle weakness (myasthenia gravis).
• If the patient has short periods of breathing cessation during sleep (sleep apnea syndrome).
• If the patient has severe liver damage.
• If the patient has severe and/or sudden respiratory failure.
• If the patient has ever experienced sleepwalking or other unusual behaviors during sleep after taking Onirex or another medicine containing zolpidem. These include driving, eating, making phone calls, or having sex while asleep, without fully waking up.

Warnings and precautions General

Before starting treatment with Onirex, the patient should discuss it with their doctor or pharmacist. The cause of insomnia should be explained, and if possible, the underlying diseases that cause it should be treated before the doctor recommends taking a sleep medicine, especially if insomnia lasts longer than 6 weeks. If treatment with Onirex does not produce results after 7 to 14 days, the patient's condition should be re-evaluated.
The duration of treatment should be as short as possible. Treatment should never last longer than 4 weeks, including the period of tapering off the medicine. This time may be extended only after re-evaluation of the patient's condition.
Particular caution should be exercised when using zolpidem

• If the patient has chronic (long-term) respiratory disorders. Respiratory disorders may worsen.
• If the patient has liver function disorders.

Children and adolescents under 18 years of age
Since no adequate studies have been conducted on the safety and efficacy of zolpidem, the doctor will not prescribe this medicine to these patients.
Elderly and debilitated patients
Elderly patients (over 65 years) or debilitated patients may be particularly sensitive to the effects of zolpidem. In these patients, symptoms of fatigue may persist after waking up.
Caution should be exercised when getting up at night: risk of falls!
Liver damage
Particular attention should be paid to dosage recommendations, as the effect of zolpidem may last longer. The doctor will regularly monitor the treatment.
Tolerance
In the case of repeated use of zolpidem or other sleep medicines for more than a few weeks, the sleep-inducing effect may weaken.
Dependence
Taking zolpidem may lead to abuse and/or development of physical and psychological dependence. The risk of dependence is greater when zolpidem is used for more than 4 weeks. The risk of abuse and dependence increases with the size of the dose and the duration of treatment and is greater in patients with a history of mental disorders and/or alcohol or drug dependence. The patient should tell their doctor if they have ever had mental disorders or been dependent on alcohol or drugs.
In the case of physical dependence, sudden discontinuation of treatment may be accompanied by withdrawal symptoms, such as headache, muscle pain, increased anxiety and tension, restlessness, and irritability.
In severe cases, symptoms such as loss of sense of reality, isolation from others, increased sensitivity to sound, numbness and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures may occur.
Rebound insomnia
After discontinuation of zolpidem or other sedatives, a recurrence of symptoms may occur with greater intensity than those initially treated. Symptoms may be accompanied by other reactions, such as mood changes, restlessness, and anxiety.
The risk of rebound insomnia is more likely in the case of sudden discontinuation of the medicine, so it is recommended to gradually reduce the dose.
Depression
Like other sleep or sedative medicines, zolpidem should be used with caution in patients with symptoms of depression or anxiety associated with depression. In certain circumstances, symptoms of depression may worsen if the underlying disease is not properly treated with appropriate medicines (antidepressants). In these patients, there may be a greater risk of suicide. Pre-existing depression may be revealed during treatment with zolpidem. Some studies have shown an increased risk of suicide or attempted suicide in patients taking certain sedatives and sleep medicines, including zolpidem. However, it has not been established whether this is caused by taking the medicine or other factors. The patient should immediately inform their doctor if they experience suicidal thoughts (thoughts of self-harm or suicide) or suicidal behavior.
Amnesia
Zolpidem or other sedatives may cause amnesia, usually a few hours after taking the medicine. To reduce the risk of these symptoms, the patient should have the opportunity for uninterrupted sleep lasting 8 hours.
Psychological reactions and "paradoxical"
During treatment with zolpidem, the following reactions may occur: restlessness, increased sleep disorders, excitement, irritability, aggression, delusions, fits of rage, nightmares, mental disorders, sleepwalking, and inadequate behavior.
In elderly patients or when consuming alcohol and other medicines, the risk of such behaviors seems to be greater, as well as after taking zolpidem in doses larger than the recommended maximum dose.
Somnambulism and related behaviors
Sleepwalking and other similar behaviors, such as driving while asleep, preparing and eating meals, making phone calls, or having sex while asleep, without remembering the actions, have been reported in patients taking zolpidem and not being fully awake. Concurrent consumption of alcohol and other medicines seems to increase the risk of such behaviors, as well as taking zolpidem in doses larger than the recommended maximum dose. In patients reporting such behaviors (e.g., driving while asleep), it is recommended to discontinue zolpidem due to the risk to themselves and others. If the patient experiences such behaviors, they should tell their doctor.
Falls
The use of benzodiazepines, including zolpidem, has been associated with an increased risk of falls.
Falls may be caused by benzodiazepine side effects, such as coordination disorders, muscle weakness, dizziness, drowsiness, and fatigue. The risk of falls is greater in elderly patients or when using a larger dose than recommended.
Psychomotor disorders the next day (see also "Driving and operating machinery")
Machinery")
The next day after taking Onirex, the risk of psychomotor disorders, including impaired driving ability, may be increased if:

• The patient took the medicine less than 8 hours before activities requiring increased alertness.
• The patient took a dose larger 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 taking prohibited substances.

The patient should take a single dose directly before sleep.
The patient should not take another dose on the same night.
Special patient groups
Zolpidem should be used with caution in patients:

• who have breathing difficulties (respiratory disorders);
• who have symptoms of depression (risk of suicidal tendencies). During treatment with sedatives, hidden depression (pre-existing depression) may be revealed;
• with a history of mental disorders and/or alcohol or drug dependence;
• with a prolonged QT interval syndrome (congenital heart rhythm disorders). The smallest available daily dose of zolpidem should be used.

Onirex and other medicines

Tell your doctor or pharmacistabout all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
When taking zolpidem with certain medicines, sedation, drowsiness, 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(sleep medicines)
• Medicines that calm or reduce anxiety(sedatives)
• 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, rash, or other allergiesthat may cause drowsiness in the patient (sedating antihistamines)
• Muscle relaxants with a central action; the muscle relaxant effect and the risk of falls may be increased, especially in elderly patients and when using larger doses.

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 weaken the effect of Onirex, e.g., rifampicin (an antibiotic used, for example, to treat tuberculosis).
Onirex with food, drink, and alcohol
Grapefruit juice may increase the effect of zolpidem. Therefore, the patient should not consume grapefruit juice during treatment with zolpidem. The patient should avoid consuming alcohol while taking zolpidem, as its sedative effect may be increased when consumed with alcohol.
Opioids
Concomitant use of zolpidem with opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when other treatment methods are not possible.
If, however, the doctor has prescribed zolpidem with opioids, the patient should use the smallest effective dose, and the duration of treatment should be as short as possible.
The patient should tell their doctor about all opioid medicines they are taking and strictly follow the doctor's instructions. It may be helpful to inform friends or relatives about the possibility of the above-mentioned symptoms. In case of such symptoms, the patient should contact their doctor.
Painkillers
When taking zolpidem with narcotic painkillers, an increased sense of well-being may occur, which may increase the risk of psychological dependence.

Pregnancy, breastfeeding, and fertility Pregnancy

Zolpidem should not be used 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 or pharmacist before taking this medicine.
Taking zolpidem during pregnancy is associated with a risk of effects on the baby.
Some studies have shown an increased risk of cleft lip and palate (sometimes called "harelip") in newborns.
After taking zolpidem in the second and/or third trimester of pregnancy, a decrease in fetal movement and variability of fetal heart rate may occur.
If zolpidem is used in the late stages of pregnancy or during labor, newborns may experience muscle weakness, decreased body temperature, difficulty sucking, and breathing difficulties (respiratory depression).
Regular intake of the medicine in the late stages of pregnancy may lead to physical dependence in the baby and the risk of withdrawal symptoms, such as excitement or tremors. In such cases, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Zolpidem should not be used during breastfeeding, as zolpidem may pass into breast milk.

Driving and operating machinery

Onirex has a major impact on the ability to drive and operate machinery and may cause events such as "falling asleep at the wheel". The patient should be aware that the next day after taking Onirex (like other sleep medicines), it may happen that:

• The patient feels drowsy, sleepy, dizzy, or disoriented,
• The patient needs more time to make quick decisions (impaired reflexes),
• The patient may see double or blurred vision,
• The patient may be less alert.

To reduce the risk of the above-mentioned events, it is recommended to maintain an interval of at least 8 hours between taking zolpidem and driving, operating machinery, or working at heights.
The patient should not consume alcohol or psychoactive substances while taking Onirex, as this may increase the above-mentioned effects.

Onirex contains lactose

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

Onirex 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 Onirex

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Onirex is 10 mg per 24 hours. The doctor may prescribe a smaller dose to some patients. Onirex should be taken:

• in a single dose,
• directly before sleep,
• 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.
Do not exceed the dose of 10 mg per 24 hours.

Adults

The usual dose is 10 mg (1 tablet).

Elderly or debilitated patients

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

Liver function disorders

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

Kidney function disorders

The usual dose is 10 mg (1 tablet).

Use in children

Onirex should not be used in children and adolescents under 18 years of age due to the lack of data confirming safety in this age group.

Method of administration

Oral administration.
The tablet should be taken directly before sleep, with an appropriate amount of liquid (e.g., 1 glass of water). After taking the tablet, it is recommended to have at least 7-8 hours of sleep.

Duration of treatment

Treatment should be as short as possible and should not last longer than 4 weeks, including the period of tapering off the medicine, as the risk of abuse and dependence increases with the duration of treatment. The doctor will inform the patient in detail about the duration of treatment. In some cases, the doctor may decide to extend the treatment period.

Overdose of Onirex

In case of taking a larger dose than recommended, the patient should immediately consult their doctor or pharmacist.
In case of overdose, symptoms may range from extreme drowsiness to mild coma. In cases of overdose or suspected overdose, the patient should immediatelyconsult their doctor.
If the patient (or someone else) has taken a large number of tablets at once, or if there is a suspicion that a child has swallowed a tablet, the patient should immediately contact their doctor or go to the nearest hospital emergency department. The patient should take the medicine packaging and any remaining tablets with them. The patient should go to the hospital accompanied by someone else. If there is an overdose, the patient may become very sleepy, which may lead to coma or even death after large doses of the medicine. Concurrent intake of zolpidem with other substances that have a sedative effect on the central nervous system (including alcohol) may have serious consequences, including death. In moderate cases, symptoms include drowsiness, confusion, and a feeling of fatigue and exhaustion (lethargy). In severe cases, symptoms may include lack of coordination (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, impaired consciousness up to coma, and more severe symptoms, including death.

Missed dose of Onirex

It may happen that the patient forgets to take zolpidem. In such a case, it is not necessary to take the missed tablet. 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 Onirex

The patient should not suddenly stop taking zolpidem; withdrawal symptoms may occur, such as headache or muscle pain, extreme anxiety and tension, restlessness, confusion, and irritability. The patient should consult their doctor to stop treatment by gradually reducing the dose.

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

4. Possible side effects

Like all medicines, Onirex can cause side effects, although not everybody gets them.
At the beginning of treatment, the following side effects most often occur: drowsiness the next day, emotional numbness, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, coordination disorders (ataxia), and double vision. These side effects usually disappear during treatment. Other side effects have been reported, such as gastrointestinal disorders, changes in libido, and skin reactions.
Frequentside effects (may occur in up to 1 in 10 people):

• Upper and lower respiratory tract infections
• Hallucinations, excitement, nightmares, worsening of sleep disorders (insomnia), depression
• Drowsiness the next day, emotional numbness, headache, dizziness, memory loss a few hours after taking zolpidem (anterograde amnesia; its occurrence is more likely if the patient sleeps less than 7 or 8 hours)
• Diarrhea, nausea, vomiting, abdominal pain
• Back pain
• Fatigue
• Dizziness

Uncommonside effects (may occur in up to 1 in 100 people):

• Changes in appetite
• State of confusion, irritability, restlessness, aggression, sleepwalking, or driving while asleep, euphoric mood;
• Itching, tingling, or numbness without cause (paresthesia), involuntary muscle movements (tremor), attention disorders, speech disorders
• Blurred vision, double vision
• Increased liver enzyme activity
• Skin rash, itching, excessive sweating
• Joint pain, muscle pain, muscle cramps, neck pain, muscle weakness

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

• Changes in sex drive
• Decreased alertness, coordination disorders (ataxia)
• Various liver damage
• Rash with severe itching (urticaria) and lump formation, urticaria
• Abnormal gait
• Falls (especially in elderly patients or when the medicine is not taken as recommended)

Very rareside effects (may occur in less than 1 in 10,000 people):

• Worsening of vision (visual impairment)
• Delusions, physical and psychological dependence
• Respiratory depression

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

• Sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), difficulty breathing and/or itching and rash, often due to an allergic reaction (angioedema)
• Outbursts of anger, abnormal behavior, and psychosis, drug abuse, delirium
• Drug dependence

During treatment with zolpidem, hidden depression may be revealed.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Onirex

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. 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.
Store in the original package.
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 Onirex contains

The active substance of the medicine is zolpidem tartrate.
Each tablet contains 10 mg of zolpidem tartrate.
Other ingredients of the medicine:
Core:lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose type A, hypromellose, magnesium stearate.
Coating Opadry Y-1-700 White:titanium dioxide (E 171), hypromellose, macrogol 400.

What Onirex looks like and contents of the pack

Onirex tablets are white, oval, coated, with a dividing line on both sides, with the inscription "ZIM" and "10" on one side. The tablet can be divided into two halves.
Available packages:
10, 20, or 100 coated tablets in blisters, placed in a carton box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania, S.L.
Castelló 1
Polígono Industrial Las Salinas
08830 Sant Boi de Llobregat
Spain
Industria Química y Farmacéutica VIR, S.A.
C/Laguna 66-70
Pol. Industrial Urtinsa II
28923 Alcorcón – Madrid
Spain
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

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

Austria:
Zoldem 10 mg, Filmtabletten
Denmark:
Zovand 10 mg
Finland:
Somnor 10 mg
Spain:
Zolpidem Vir 10 mg comprimidos recubiertos con película EFG
Netherlands:
Zolpidemtartraat 10 mg filmomhulde tabletten
Iceland:
Zovand 10 mg
Poland:
Onirex
Portugal:
Zolpidem Generis, 10 mg comprimidos revestidos
Czech Republic:
Onirex
Date of last revision of the leaflet:07.2024