Package leaflet: Information for the user

Onirex, 10 mg, coated tablets
Zolpidem tartrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm
other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or
pharmacist. See section 4.
Contents of the leaflet

What Onirex is and what it is used for
Important information before taking Onirex
How to take Onirex
Possible side effects
How to store Onirex
Contents of the pack and other information

1. What Onirex is and what it is used for

Onirex belongs to a group of medicines with effects similar to benzodiazepines, used in the treatment
of sleep disorders.
Onirex has a calming and sleep-inducing effect. It therefore reduces the time needed to fall asleep, decreases the number of
nocturnal awakenings, and prolongs the duration of deep sleep.
Onirex is used for the short-term treatment of insomnia in adults, and only in severe sleep disorders that significantly impair
normal functioning or cause extreme distress to the patient.
This medicine must not be used for prolonged periods. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.

2. Important information before using Onirex

When not to use 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 suffers from brief periods of breathing cessation during sleep (sleep apnoea syndrome).
if the patient has severe liver impairment.
if the patient has severe and (or) acute respiratory depression.
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 engaging in sexual activity while asleep, without fully waking up.

Warnings and precautions
General
Before starting treatment with Onirex, discuss this with your doctor or pharmacist. The cause of insomnia should be investigated and, if possible, any underlying disorders causing insomnia should be treated before prescribing a sleeping medicine, especially if insomnia persists for more than 6 weeks. If treatment with Onirex does not produce results within 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 tapering-off period. This period may be extended only after re-evaluation of the patient's condition.
Special caution is required when using zolpidem:

If the patient has chronic (long-term) respiratory disorders. Breathing problems may worsen.
If the patient has impaired liver function.

Children and adolescents under 18 years of age
As adequate studies on the safety and efficacy of zolpidem have not been conducted, doctors will not prescribe this medicine for these patients.
Elderly and debilitated patients
Elderly patients (over 65 years of age) or debilitated patients may be particularly sensitive to the effects of zolpidem. In these patients, symptoms of fatigue may persist after waking up. Caution is advised when getting up at night: risk of falling!
Liver impairment
Particular attention should be paid to dosing recommendations, as the effect of zolpidem may last longer. The doctor will monitor treatment regularly.
Tolerance
Repeated use of zolpidem or other sleeping medicines for longer than a few weeks may lead to reduced hypnotic effect.
Dependence
Use of zolpidem may lead to drug abuse and (or) development of physical and psychological dependence. The risk of dependence is higher when zolpidem is used for longer than 4 weeks. The risk of abuse and dependence increases with dose and duration of treatment and is higher in patients with psychiatric disorders and (or) a history of alcohol or drug dependence. Inform your doctor if you have ever had psychiatric disorders or been dependent on alcohol, drugs, or other substances.
In cases of physical dependence, abrupt discontinuation of treatment may lead to withdrawal symptoms such as headache, muscle pain, increased anxiety and tension, restlessness, confusion, and irritability.
In severe cases, symptoms may include: loss of reality, social withdrawal, increased auditory sensitivity, numbness and tingling in limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures.
Rebound insomnia
After stopping treatment with zolpidem or other sedative medicines, a recurrence of symptoms may occur, more intense than those originally treated. This may be accompanied by other reactions such as mood changes, restlessness, and anxiety.
The risk of rebound insomnia is higher with abrupt discontinuation; therefore, gradual dose reduction is recommended.
Depression
As with other sleeping or sedative medicines, zolpidem should be used with caution in patients with symptoms of depression or anxiety associated with depression. In certain circumstances, depressive symptoms may worsen if the underlying condition is not properly treated with appropriate medicines (antidepressants). These patients may have an increased risk of suicide. Pre-existing depression may emerge during treatment with zolpidem. Some studies have shown an increased risk of suicide or suicide attempts in patients taking certain sedative and hypnotic medicines, including zolpidem. However, it has not been established whether this is due to the medicine or other factors. Immediately inform your doctor if the patient experiences suicidal thoughts (thoughts of self-harm or suicide) or suicidal behavior.
Memory loss (amnesia)
Zolpidem or other sedative medicines may cause memory loss (amnesia), usually a few hours after taking the medicine. To reduce the risk of these symptoms, the patient should ensure uninterrupted sleep of 8 hours.
Psychological and "paradoxical" reactions
During treatment with zolpidem, the following reactions may occur: anxiety, worsening of sleep disturbances, agitation, irritability, aggression, hallucinations, rage attacks, nightmares, psychiatric disturbances, sleepwalking, inappropriate behavior, and other undesirable behavioral disturbances.
The risk of such behaviors appears to be higher in elderly patients, when alcohol or other medicines are taken concomitantly, and after using zolpidem in doses higher than the recommended maximum dose.
Somnambulism and related behaviors
Sleepwalking and similar behaviors, such as driving, preparing and eating meals, making phone calls, or engaging in sexual activity during sleep, with no memory of these activities, have been reported in patients taking zolpidem who were not fully awake. Concomitant use of alcohol and other medicines appears to increase the risk of such behaviors, as does using zolpidem in doses higher than the recommended maximum. Patients reporting such behaviors (e.g., driving while asleep) should discontinue zolpidem due to the risk to themselves and others. If such behaviors occur, inform your doctor.
Falls
Use of benzodiazepines, including zolpidem, has been associated with an increased risk of falls. Falls may result from adverse effects of benzodiazepines such as impaired coordination, muscle weakness, dizziness, drowsiness, and fatigue. The risk of falling is higher in elderly patients or when higher than recommended doses are used.
Next-day psychomotor disturbances (see also Driving and operating machinery)
The risk of next-day psychomotor disturbances, including impaired ability to drive, may be increased the day after taking Onirex if:

The patient took the medicine less than 8 hours before activities requiring full alertness.
The patient took a higher than recommended dose.
The patient took zolpidem while being treated with other central nervous system depressants or other medicines that increase zolpidem blood levels, while consuming alcohol, or while using illicit substances.

A single dose should be taken immediately before bedtime.
Do not take another dose during the same night.
Special patient groups
Zolpidem should be used with caution in patients:

with breathing difficulties (respiratory disorders);
with symptoms of depression (risk of suicidal tendencies). Hidden depression (pre-existing depression) may emerge during treatment with sedative medicines;
with a history of psychiatric disorders and (or) alcohol or drug dependence;
with QT interval prolongation syndrome (congenital heart rhythm disorders). The lowest available daily dose of zolpidem should be used.

Onirex with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
When zolpidem is used with certain medicines, sedation, drowsiness, and next-day psychomotor disturbances—including impaired driving ability—may be intensified. These medicines include:

Medicines used in the treatment of certain mental health disorders (antipsychotics)
Medicines used for sleep problems (sleeping pills)
Sedatives or medicines reducing anxiety (anxiolytics)
Medicines used in the treatment of depression
Medicines used for moderate to severe pain (opioid analgesics)
Medicines used in the treatment of epilepsy
Medicines used in anesthesia
Medicines used for hay fever, rashes, or other allergies that may cause drowsiness (sedating antihistamines)
Centrally acting muscle relaxants; muscle relaxation and risk of falls may be increased, especially in elderly patients and when higher doses are used.

When zolpidem is taken with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may experience hallucinations (visual hallucinations).
Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.
Medicines that strongly increase the activity of certain liver enzymes may reduce the effect of Onirex, e.g., rifampicin (an antibiotic used, for example, in the treatment of tuberculosis).
Onirex with food, drink, and alcohol
Grapefruit juice may enhance the effect of zolpidem. Therefore, do not consume grapefruit juice during treatment with zolpidem. Avoid alcohol while taking zolpidem, as its sedative effect may be increased when alcohol is consumed simultaneously.
Opioids
Concomitant use of zolpidem with opioids (strong painkillers, medicines used in substitution therapy, and some antitussives) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
If your doctor prescribes zolpidem together with opioids, use the lowest effective dose, and treatment duration should be as short as possible.
Inform your doctor about all opioid medicines you are taking and strictly follow medical advice. It may be helpful to inform family or friends about the possibility of the above-mentioned symptoms. Contact your doctor if such symptoms occur.
Painkillers
When zolpidem is used simultaneously with opioid analgesics, increased psychological well-being may occur, increasing the risk of psychological dependence.
St. John's wort and rifampicin
Concomitant use of zolpidem with St. John's wort or rifampicin (a medicine used in the treatment of tuberculosis) may reduce its effectiveness.
Ketoconazole
Concomitant use of zolpidem with ketoconazole may enhance its effect.
Pregnancy, breastfeeding, and effects on fertility
Pregnancy
Use of zolpidem during pregnancy is not recommended. If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Use of zolpidem during pregnancy carries a risk of effects on the unborn child. Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.
Use of zolpidem in the second and (or) third trimester of pregnancy may lead to reduced fetal movements and changes in fetal heart rate variability.
If zolpidem is used near the end of pregnancy or during labor, newborns may experience muscle weakness, reduced body temperature, feeding difficulties, and breathing problems (respiratory depression).
Regular use of the medicine near the end of pregnancy may lead to physical dependence in the newborn and risk of withdrawal symptoms such as agitation 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 human milk.
Driving and operating machinery
Onirex has a major influence on the ability to drive and operate machinery and may cause events such as "falling asleep at the wheel." Patients should be aware that the day after taking Onirex (as with other sleeping medicines), the following may occur:

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

To reduce the risk of these events, a minimum of 8 hours should elapse between taking zolpidem and driving, operating machinery, or working at heights.
Do not consume alcohol or psychoactive substances while taking Onirex, as this may intensify the above-mentioned effects.
Onirex contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Onirex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free."

3. How to use Onirex

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

The recommended dose of Onirex is 10 mg every 24 hours. Your doctor may prescribe a lower dose for some patients.
Onirex should be taken:

as a single dose,
immediately before bedtime,
with liquid (e.g. a glass of water).

Patients must allow at least an 8-hour interval between taking the medicine and performing activities requiring increased concentration.
Do not exceed the dose of 10 mg every 24 hours.

Adults
The usual dose is 10 mg (1 tablet).

Elderly or debilitated patients
The initial dose is 5 mg ( / tablet).

Hepatic impairment
The initial dose is 5 mg ( / tablet).

Renal impairment
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 lack of data confirming safety of use in this age group.

Method of administration
Oral use.
The tablet should be taken immediately before bedtime, with an adequate amount of liquid (e.g. one glass of water). After taking the tablet, at least 7–8 hours of sleep are recommended.

Duration of treatment
Treatment should be as short as possible and should not last longer than four weeks, including the period of discontinuation, because the risk of misuse and dependence increases with the duration of treatment. Your doctor will provide detailed information on the duration of treatment. In certain cases, your doctor may decide to extend the treatment period.

Taking more than the recommended dose of Onirex
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
In case of overdose, symptoms may range from extreme drowsiness to mild coma.
In cases of overdose or suspected overdose, you must seek immediate medical help.
If a patient (or anyone else) takes a large number of tablets at once, or if there is suspicion that a child has swallowed a tablet, contact a doctor immediately or go to the nearest hospital emergency department. Bring the medicine packaging and any remaining tablets with you. Medical help should be sought accompanied by another person. In case of overdose, the patient may become very sleepy very quickly, which with high doses of the medicine may lead to coma or even death. Concurrent use of zolpidem with other substances that depress the central nervous system (including alcohol) may have serious consequences, including death. In moderate cases, symptoms include: drowsiness, confusion, and feelings of fatigue and exhaustion (lethargy). In more severe cases, symptoms may include lack of motor coordination (ataxia), reduced muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, disturbances of consciousness up to coma, and more severe symptoms, including death.

Missed dose of Onirex
It may happen that a patient forgets to take zolpidem. In such a case, do not take the missed tablet. Take the dose prescribed by your doctor at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Onirex
Do not stop taking zolpidem suddenly; withdrawal symptoms such as headache or muscle pain, extreme anxiety and tension, motor restlessness, confusion, and irritability may occur. Consult your doctor to discontinue treatment by gradually reducing the dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions are most common at the beginning of treatment: daytime drowsiness, emotional blunting, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, coordination disorders (ataxia), and double vision. These effects usually subside during treatment. Other adverse reactions reported include gastrointestinal disorders, changes in libido, and skin reactions.

Common adverse reactions (may occur in up to 1 in 10 people):

Upper and lower respiratory tract infections
Hallucinations, restlessness, nightmares, worsening of sleep disorders (insomnia), depression
Daytime drowsiness, emotional blunting, headache, dizziness, memory loss a few hours after taking zolpidem (anterograde amnesia; more likely if the patient sleeps less than 7 or 8 hours)
Diarrhoea, nausea, vomiting, abdominal pain
Back pain
Fatigue
Sensation of spinning

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

Appetite disturbances
Confusion, irritability, anxiety, aggression, sleepwalking or sleep-driving, euphoric mood
Tingling, itching or pins and needles sensation without cause (paraesthesiae), involuntary muscle movements (tremor), attention disturbances, 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

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

Changes in sexual drive
Reduced alertness, coordination disorders (ataxia)
Various types of liver damage
Rash with severe itching (urticaria) and formation of nodules, urticaria
Abnormal gait
Falls (particularly in elderly patients or when the medicine is not taken as recommended)

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

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

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

Sudden accumulation of fluid in the skin and mucous membranes (e.g. throat or tongue), breathing difficulties and (or) itching and rash, often due to an allergic reaction (angioedema)
Sudden outbursts of anger, abnormal behaviour and psychosis, medicine misuse, delirium
Drug dependence

Use of zolpidem may unmask underlying depression.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Onirex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging
and blister pack. 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 stated month.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Onirex contains
The active substance is zolpidem tartrate.
Each tablet contains 10 mg of zolpidem tartrate.
Other ingredients of the medicine:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch type A, hypromellose, magnesium stearate.
Tablet coating Opadry Y-1-700 White: titanium dioxide (E 171), hypromellose, polyethylene glycol 400.

What Onirex looks like and contents of the pack
Onirex tablets are white, oval, film-coated, with a central break line on both sides and engraved with "ZIM" and "10" on one side. The tablet can be divided into two equal parts.
Available pack sizes:
10, 20 or 100 film-coated tablets in blisters, placed in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
The 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised 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
The Netherlands: Zolpidemtartraat 10 mg filmomhulde tabletten
Iceland: Zovand 10 mg
Poland: Onirex
Portugal: Zolpidem Generis, 10 mg comprimidos revestidos
Czech Republic: Onirex