ZOLPIDEM 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Zolpidem Genoptim, 10 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet:
3. What Zolpidem Genoptim is and what it is used for
4. Important information before taking Zolpidem Genoptim
   1. When not to take Zolpidem Genoptim
   2. Warnings and precautions
   3. Zolpidem Genoptim and other medications
   4. Zolpidem Genoptim with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Zolpidem Genoptim contains lactose
5. How to take Zolpidem Genoptim
   1. Duration of treatment
   2. Overdose of Zolpidem Genoptim
   3. Missed dose of Zolpidem Genoptim
   4. Discontinuation of Zolpidem Genoptim
6. Possible side effects
   1. Reporting side effects
7. How to store Zolpidem Genoptim
8. Contents of the pack and other information
   1. What Zolpidem Genoptim contains
   2. What Zolpidem Genoptim looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Zolpidem Genoptim, 10 mg, Film-Coated Tablets

Zolpidem Tartrate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What Zolpidem Genoptim is and what it is used for

Zolpidem Genoptim belongs to a group of medicines called anxiolytics, sedatives, and hypnotics (therapeutic group: 2.9.1). Each film-coated tablet of Zolpidem Genoptim 10 mg contains 10 mg of zolpidem tartrate (Zolpidem Tartrate).
Zolpidem Genoptim is indicated for the short-term treatment of insomnia in adults, when insomnia is severe or causes significant distress to the patient.

2. Important information before taking Zolpidem Genoptim

When not to take Zolpidem Genoptim

• If you are allergic (hypersensitive) to the active substance zolpidem or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver impairment.
• If you have acute and severe respiratory depression.
• If you are under 18 years of age.

Warnings and precautions

Before starting treatment with Zolpidem Genoptim, discuss it with your doctor or pharmacist.
Zolpidem should be used with caution in patients with sleep apnea syndrome and myasthenia.
Respiratory depression: when administering zolpidem to patients with impaired respiratory function, caution should be exercised, as sedatives can inhibit respiratory function.
Liver function disorders: see the recommendations in the section on dosage and administration.
The cause of insomnia should be determined, if possible, and the underlying factors eliminated before the patient starts taking a sedative.
Persistence of insomnia after 7-14 days of treatment may indicate the presence of underlying psychiatric or physical disorders that require diagnosis and evaluation at regular intervals.
Duration of treatment
The duration of treatment should be as short as possible (see Dosage) depending on the indication, but should not exceed four weeks in the case of insomnia, including the period of dose reduction. If treatment needs to be prolonged, the patient's condition should always be re-evaluated.
Psychotic illness
Sedatives, such as zolpidem, are not recommended for the primary treatment of psychotic illnesses.
Depression
Although no significant pharmacokinetic and pharmacodynamic interactions have been demonstrated with SSRIs (selective serotonin reuptake inhibitors), as with other sedatives/hypnotics, zolpidem should be used with caution in patients with symptoms of depression. Suicidal thoughts may occur, and therefore the doctor should prescribe the lowest possible dose of zolpidem to prevent intentional overdose by the patient. During zolpidem treatment, hidden depression (previously occurring depression) may be revealed. Since insomnia can be a symptom of depression, the patient should be re-examined by a doctor in case of persistent insomnia.
General information about the effects observed after administration of sedatives, which the doctor should take into account, is described below.
Next-day psychomotor disorders(see also Driving and using machines)
The next day after taking Zolpidem Genoptim, the risk of psychomotor disorders, including impaired driving ability, may be increased if:

• The patient took the medication less than 8 hours before activities that require increased alertness.
• The patient took a higher dose than recommended.
• The patient took zolpidem during treatment with other medications that have a depressant effect on the central nervous system or other medications that increase the concentration of zolpidem in the blood while consuming alcohol or taking prohibited substances.

A single dose should be taken immediately before bedtime.
Do not take another dose on the same night.
Amnesia
To reduce the risk of developing subsequent amnesia, which usually occurs a few hours after taking the medication, the patient should have the opportunity for uninterrupted sleep lasting 7-8 hours before taking the medication.
Psychotic reactions and "paradoxical" reactions
During the use of benzodiazepines or benzodiazepine-like medications, reactions such as psychomotor stimulation, irritability, aggression, delusions, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other undesirable effects related to behavior may occur. If such reactions occur, the medication should be discontinued. Such reactions are more likely to occur in elderly patients.
Somnambulism and other similar behaviors
In patients who have taken zolpidem and have not fully awakened, activities such as sleepwalking and other similar behaviors, such as driving while asleep, preparing and consuming food, making phone calls, or having sex while asleep, which the patient will not remember after waking up, may occur.
The risk of these adverse reactions is increased by alcohol and certain medications used to treat depression or anxiety disorders, as well as by taking zolpidem in doses exceeding the recommended maximum dose. In patients reporting such behaviors (e.g., driving while asleep), consideration should be given to discontinuing zolpidem due to the risk of harm to themselves and their environment (see section 2 "Zolpidem Genoptim and other medications" and section 4 "Possible side effects").
Tolerance
During the use of benzodiazepines and short-acting benzodiazepine-like medications for several weeks, a decrease in their sedative effect may occur.
Dependence
The use of benzodiazepines or benzodiazepine-like medications can lead to the development of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment; dependence is greater in patients with a history of mental disorders and (or) alcohol or drug dependence. Such patients should be closely monitored during treatment with sedatives.
In cases where physical dependence has developed, sudden discontinuation of treatment may be accompanied by withdrawal symptoms, such as headaches or muscle pain, increased anxiety and tension, psychomotor stimulation, confusion, and irritability.
In severe cases, symptoms such as loss of reality, depersonalization, hypersensitivity to sound, numbness and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures may occur.
Rebound insomnia
After discontinuing sedative treatment, a transient syndrome may occur, in which the symptoms treated with benzodiazepines or benzodiazepine-like medications recur with greater intensity than initially. Other symptoms, such as mood changes, anxiety, and psychomotor stimulation, may also appear. It is essential to inform the patient about the rebound effect to minimize anxiety and other symptoms if they occur after discontinuing the medication.
In the case of short-acting sedatives and hypnotics, withdrawal symptoms may occur between doses.
Special patient groups
The safety and efficacy of zolpidem in patients under 18 years of age have not been established.
In an 8-week study involving children and adolescents (aged 6 to 17 years) with insomnia associated with attention deficit hyperactivity disorder (ADHD), psychiatric disorders and nervous system disorders were the most common adverse reactions observed during zolpidem treatment compared to placebo and included dizziness (23.5% vs 1.5%), headache (12.5% vs 9.2%), and hallucinations (7.4% vs 0%), (see section 3 "How to take Zolpidem Genoptim").
Elderly patients(see Dosage recommendations)
Caution should be exercised when prescribing zolpidem to patients with severe respiratory impairment.
Benzodiazepines and benzodiazepine-like medications are not recommended for the treatment of patients with severe liver function disorders, as they may accelerate encephalopathy.
Benzodiazepines or benzodiazepine-like medications should not be used as the primary treatment for psychotic illnesses.
Benzodiazepines or benzodiazepine-like medications should not be used as monotherapy for the treatment of depression or anxiety associated with depression (risk of suicidal tendencies).
Concomitant administration of benzodiazepines or benzodiazepine-like medications is not recommended in patients with a history of alcohol or drug abuse.

Zolpidem Genoptim and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Medications with a depressant effect on the central nervous system:
When taking zolpidem with the medications listed below, drowsiness and next-day psychomotor disorders, including impaired driving ability, may be increased.

• Medications used to treat certain mental health disorders (antipsychotics)
• Medications used to treat sleep disorders
• Sedatives or anxiolytics
• Medications used to treat depression
• Medications used to treat moderate to severe pain (narcotic analgesics)
• Medications used to treat epilepsy
• Medications used in anesthesia
• Medications used to treat hay fever, rash, or other allergies that may cause drowsiness in the patient (sedating antihistamines).

When taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not there (hallucinations).
Cytochrome P450 inhibitors and inducers
Substances that inhibit certain liver enzymes (especially cytochrome P450) may increase the activity of benzodiazepines or benzodiazepine-like medications. Zolpidem is metabolized by several liver enzymes of the cytochrome P450 system, with CYP3A4 being the main one, and CYP1A2 to a lesser extent. The pharmacodynamic effect of zolpidem is reduced when administered with rifampicin (CYP3A4 inducer). On the other hand, the administration of zolpidem with itraconazole (CYP3A4 inhibitor) had no significant effect on its pharmacokinetics and pharmacodynamics. The clinical significance of these results is unknown.
Concomitant administration of zolpidem with ketoconazole (200 mg twice daily), a potent CYP3A4 inhibitor, prolonged the elimination half-life of zolpidem, increased the total AUC, and decreased the apparent clearance after oral administration compared to zolpidem and placebo. In the case of concomitant administration with ketoconazole, the total AUC of zolpidem was increased by 1.83 compared to zolpidem alone. Routine dose adjustment is not considered necessary, but patients should be informed that taking zolpidem with ketoconazole may increase the sedative effect.
Other medications
No significant pharmacokinetic interactions were observed after administration of zolpidem with warfarin, digoxin, or ranitidine.
It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.

Zolpidem Genoptim with food and drink

Do not consume alcohol while taking Zolpidem Genoptim, as it may increase the sedative effect of the medication, affecting the ability to drive and operate machinery.

Pregnancy, breastfeeding, and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medication.
Zolpidem Genoptim should not be used during pregnancy as a precautionary measure.
There are no sufficient data on the safety of zolpidem during pregnancy and lactation.
Animal studies have not shown any direct or indirect harmful effects on reproductive toxicity.
Women of childbearing age taking Zolpidem Genoptim should contact their doctor to stop treatment if they plan to become pregnant or think they may be pregnant.
If a patient takes Zolpidem Genoptim in high doses in late pregnancy or during childbirth, the newborn may experience symptoms such as low body temperature, muscle weakness, and moderate respiratory depression. There have been reports of severe respiratory depression in newborns when zolpidem was used in combination with other central nervous system depressants (including alcohol) in late pregnancy. Additionally, newborns of mothers who have taken benzodiazepines or benzodiazepine-like medications in late pregnancy may develop physical dependence and be at risk of withdrawal symptoms in the postpartum period.
Breastfeeding
Zolpidem Genoptim should not be used during breastfeeding, as a small amount of the medication passes into breast milk.

Driving and using machines

Zolpidem Genoptim has a major impact on the ability to drive and operate machinery, and may cause events such as "falling asleep at the wheel".
The next day after taking Zolpidem Genoptim (like other sedatives), it may happen that:

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

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

Zolpidem Genoptim contains lactose

If your doctor has previously determined that you have an intolerance to some sugars, e.g., lactose, you should consult your doctor before taking this medication.

3. How to take Zolpidem Genoptim

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Zolpidem Genoptim is 10 mg per day. Your doctor may prescribe a lower dose for some patients.
Zolpidem Genoptim should be taken as a single dose, immediately before bedtime. The patient must maintain an interval of at least 8 hours between taking the medication and engaging in activities that require increased concentration.
Do not exceed the dose of 10 mg per 24 hours.
Treatment should be as short as possible. The maximum treatment period, including the dose reduction period, is four weeks.
In some cases, it may be necessary to extend the treatment period beyond the maximum recommended time, but this should not be done without re-evaluating the patient's clinical condition.
Special patient groups:
Children and adolescents
The safety and efficacy of zolpidem in children and adolescents under 18 years of age have not been established. Therefore, Zolpidem Genoptim is not intended for use in this patient group.
Elderly patients
In elderly or weakened patients who may be particularly sensitive to the medication, the recommended dose is 5 mg. This dose may be increased only in exceptional cases. In this patient group, the daily dose should not exceed 10 mg.
Patients with liver function disorders
In patients with liver function disorders, due to reduced clearance and metabolism of zolpidem, the initial dose should be 5 mg, with particular caution, especially in elderly patients. In adult patients (under 65 years of age), the dose may be increased by the doctor to 10 mg, but only if there is an insufficient clinical response and the medication is well tolerated. Zolpidem Genoptim is administered orally.
In each case, if possible, the cause of insomnia should be determined and the underlying factors eliminated before the patient starts taking a sedative. The lack of improvement in insomnia after 7-14 days of treatment may indicate the presence of an underlying psychiatric or physical disorder, and therefore the patient should be subjected to thorough evaluation at regular intervals. This medication should be taken immediately before bedtime or when already in bed.

Duration of treatment

Treatment should be as short as possible. Usually, treatment lasts from a few days to two weeks.
The maximum treatment period, including the dose reduction period, is four weeks.
The doctor will determine the dose reduction schedule based on the individual needs of the patient.
At the beginning of treatment, the doctor should inform the patient that treatment is limited in time and explain how the dose will be gradually reduced. In some cases, it may be necessary to extend the use of the medication beyond the maximum treatment period. In such cases, a re-evaluation of the patient's clinical condition is required.

Overdose of Zolpidem Genoptim

Objective and subjective symptoms:
There have been reports of zolpidem overdose, resulting in consciousness disorders of varying severity - from drowsiness to coma. Overdose cases of zolpidem and other central nervous system depressants (including alcohol consumption) have led to severe symptoms, including death.
Treatment:
After an overdose of zolpidem, symptomatic and supportive treatment is recommended. Gastric lavage is not beneficial, so activated charcoal should be administered to reduce the absorption of the medication from the gastrointestinal tract.
Sedatives should be discontinued, even in the case of occurring stimulation.
In the event of severe symptoms, the doctor will consider administering flumazenil. However, the use of flumazenil may cause neurological symptoms (seizures).
Zolpidem is not eliminated from the body by hemodialysis.

Missed dose of Zolpidem Genoptim

Do not take a double dose to make up for a missed dose. Discontinuation of treatment may cause withdrawal symptoms or rebound insomnia, so the doctor's instructions should be followed.

Discontinuation of Zolpidem Genoptim

Discontinuation of Zolpidem Genoptim should be done gradually, and the dose reduction process should be determined individually for each patient and in accordance with the doctor's recommendations.
In case of any further doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Zolpidem Genoptim can cause side effects, although not everybody gets them.
The following frequency classification is used for side effects: MedDRA:
Very common (≥1/10); Common (≥1/100, <1>

• There is evidence of a relationship between the severity of zolpidem's side effects and the dose used, especially for certain central nervous system side effects.

Side effects are less severe if the medication is taken immediately before bedtime or when already in bed. They most often occur in elderly patients.
Infections and infestations
Common: upper respiratory tract infection, lower respiratory tract infection.
Immune system disorders
Frequency not known: angioedema.
Psychiatric disorders
Common: hallucinations, psychomotor stimulation, nightmares.
Uncommon: confusion, irritability.
Frequency not known: restlessness, aggression, delusions, rage, psychosis, abnormal behavior, sleepwalking, dependence (after discontinuation of treatment, withdrawal symptoms or rebound insomnia may occur), libido disorders, depression.
Most of the aforementioned psychiatric disorders are related to paradoxical reactions.
Nervous system disorders
Common: drowsiness, headache, vertigo, increased insomnia, anterograde amnesia (may be associated with inappropriate behavior).
Frequency not known: decreased level of consciousness.
Eye disorders
Uncommon: double vision.
Respiratory, thoracic, and mediastinal disorders
Frequency not known: respiratory depression.
Gastrointestinal disorders
Common: diarrhea, nausea, vomiting, abdominal pain.
Hepatobiliary disorders
Frequency not known: increased liver enzyme activity.
Skin and subcutaneous tissue disorders
Frequency not known: rash, angioedema, itching, urticaria, excessive sweating.
Musculoskeletal and connective tissue disorders
Frequency not known: muscle weakness.
General disorders and administration site conditions
Common: fatigue
Frequency not known: gait disorders, tolerance to the medication, falls (especially in elderly patients and if zolpidem is not taken according to the doctor's recommendations).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. 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:
Jerozolimskie Avenue 181 C,
02-222 Warsaw.
Phone: +48 22 49 21 301 Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Zolpidem Genoptim

There are no special precautions for storage.
Medicines should be kept out of the sight and reach of children.
Do not use this medication after the expiry date stated on the packaging and carton. The expiry date refers to the last day of the month. Lot means batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Zolpidem Genoptim contains

The active substance of the medication is zolpidem tartrate.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 6000, and talc.
If your doctor has previously determined that you have an intolerance to some sugars, e.g., lactose, you should consult your doctor before taking this medication.

What Zolpidem Genoptim looks like and contents of the pack

White or almost white, capsule-shaped, biconvex film-coated tablets with a dividing line on one side and the number "10" embossed on the other side.
PVC/Aluminum blisters, packaged in a carton containing 7, 14, 20, 28, 30, 56, or 84 film-coated tablets.
HDPE containers with HDPE caps, containing 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
Krakowiaków 65
02-255 Warsaw
Phone: +48 607 696 231
Email: [email protected]
Manufacturer/Importer:
Synoptis Industrial Sp. z o.o.
Rabowicka 15
62-020 Swarzędz
Poland
Sofarimex indústria Química e Farmacêutica SA
Av. Das Indústrias - Alto do Colaride - Agualva- 2735-213
Cacém, Portugal

Date of last revision of the package leaflet: