Prospecto: Information for the user

Zolpidem Stada 10 mg film-coated tablets EFG

Zolpidem tartrate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• Ifyou experience any adverse effects, consultyour doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Zolpidem Stada

3.How to take Zolpidem Stada

4.Possible adverse effects

5.Storage of Zolpidem Stada

6.Contents of the package and additional information

Zolpidem Stada is a hypnotic that belongs to a group of medications known as benzodiazepine analogs.

Zolpidem is usedfor the short-term treatment of insomniain patients over 18 years of age, in situations where insomnia is weakening or causing severe anxiety.

Do not take this medication for a long time. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.

Zolpidem is indicated for sleep rhythm disorders and all forms of insomnia, especially when there are difficulties in falling asleep, either initially or after a premature awakening.

Do not take Zolpidem Stada

-If you are allergic to zolpidem or to the group of benzodiazepines in general or to any of the other components of this medication (including in section 6).

-If you have acute and/or severe respiratory difficulties.

-If you have breathing problems during sleep (sleep apnea syndrome).

-If you have muscle weakness (myasthenia gravis).

-If you have severe liver problems (hepatic).

-As long-term treatment. The treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.

-If you have experienced sleepwalking or other unusual behaviors while sleeping (such as driving, eating, calling, or having sex, etc.) without being fully awake after taking zolpidem or other medications containing zolpidem.

Warnings and precautions

Consult your doctor or pharmacist before starting to take zolpidem.

-Your doctor should identify the causes of insomnia whenever possible and treat the underlying factors before prescribing zolpidem.

-After taking zolpidem, ensure that you can have 8 hours of uninterrupted sleep to reduce the risk of anterograde amnesia (not remembering what happened while awake).

-If you have ever had any mental disorder or problems with abuse or dependence on alcohol or drugs.

-Risk of dependence: The use of zolpidem may lead to the development of physical and psychological abuse and/or dependence. The risk of dependence is higher when zolpidem is used for more than 4 weeks. The risk of abuse and dependence is higher in patients with a history of mental disorders and/or abuse of alcohol, illicit substances, or drugs.

-To minimize the risk of dependence, consider these precautions:

-The taking of these medications will be done only under medical prescription (never because they have given results in other patients) and never advise other people,

-Do not increase the prescribed doses at all, or prolong the treatment more than recommended,

-Consult your doctor regularly to decide if you should continue treatment.

Once physical dependence has developed, abrupt discontinuation of treatment will be accompanied by a withdrawal syndrome that may consist of restlessness, anxiety, headache, muscle pain, confusion, irritability, and tension. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.

In severe cases, the following symptoms may appear: alteration of the perception of reality, depersonalization, decreased tolerance to usual sounds (hyperacusia), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.

-Rebound insomnia: In some cases, after stopping treatment, a transient syndrome may occur in which the symptoms that led to starting treatment reappear but in increased form. They may be accompanied by other reactions such as mood changes, anxiety, sleep disorders, and restlessness. It is essential to know that there is a possibility of this rebound phenomenon occurring to minimize the anxiety that may cause the appearance of these effects when stopping treatment. In the case of short-acting hypnotic/sedative medications, the withdrawal syndrome may appear within the dose interval. The probability of rebound insomnia is higher with abrupt withdrawal. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.

-It is known that other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggression, delirium, anger attacks, nightmares, psychosis, hallucinations, abnormal behavior, and other conduct alterations occur with zolpidem. Treatment should be suspended when these reactions appear. These reactions are more likely to occur in elderly patients.

- Zolpidem may cause sleepwalking or other unusual behaviors while sleeping (such as driving, eating, calling, or having sex, etc.) without being fully awake, some of which have been associated with severe injuries or even death. The next morning, you may not remember anything that happened during the night. If you experience any of the above symptoms, stop treatment with zolpidem immediately and contact your doctor or healthcare professional, as these sleep behaviors may put you and others at risk of serious injury.

Drinking alcohol or taking other sedating medications with zolpidem may increase the risk of these sleep behaviors.

The use of zolpidem with alcohol and other central nervous system depressants, or taking higher doses than recommended may increase the risk of these behaviors. Your doctor should consider stopping treatment in these cases, as it may pose a risk to you and others.

- This medication may cause drowsiness and a decrease in consciousness, which may cause falls and consequently cause serious injuries.

- After repeated use for several weeks, some tolerance to the product may appear, so you may lose some of the hypnotic effects.

-If you have a history of drug or alcohol dependence, do not take zolpidem unless your doctor tells you to.

- If you have congenital long QT syndrome, your doctor should carefully consider the benefit-risk ratio before starting treatment with zolpidem.

-In patients with mental illnesses (psychosis), it is not recommended to use it as primary treatment.

- If you have suicidal tendencies and depression, use it with extreme caution. Consult your doctor before using this medication, as it may unmask an existing depression. Some studies have shown an increase in the risk of suicidal ideation, attempt, and suicide in patients taking certain sedatives and hypnotics, including this medication. However, it has not been established whether this is caused by the medication or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for additional medical advice.

-If you have any liver disorder or respiratory problems, your doctor will decide whether you should take a lower dose of zolpidem or not take it.

-In patients with severe liver failure, zolpidem should not be taken, as it may contribute to the development of encephalopathy (brain disease).

- Do not take zolpidem at the same time as opioids (medications used to relieve intense pain, such as morphine or codeine) unless your doctor prescribes it, due to the possible risk of sedation, respiratory depression, coma, or even death (see "Zolpidem Stada use with other medications"). If your doctor finally prescribes zolpidem concomitantly with opioids, they should prescribe the minimum effective dose and for the shortest duration of concomitant use. Your doctor will monitor the appearance of signs and symptoms of respiratory depression and sedation.

-In elderly patients, the dose should be reduced. See section 3.How to take Zolpidem Stada.

-Zolpidem is not recommended in children and adolescents under 18 years old.

Altered psychomotor function the next day (see also "Driving and using machines")

Like other hypnotic/sedative medications, zolpidem has a depressive effect on the central nervous system.

The next day after taking zolpidem, there may be an increased risk of altered psychomotor function, including impaired ability to drive, if:

•You take this medication with less than 8 hours of margin before performing activities that require a state of mental alertness

•You take a higher dose than the recommended dose

•You take zolpidem at the same time as another central nervous system depressant or another medication that increases the concentration of zolpidem in your blood, combined with alcohol or illicit substances.

Take the dose once and immediately before going to bed at night.

Do not take another dose during the same night.

Use of Zolpidem Stada with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This is extremely important, as the simultaneous use of more than one medication may increase or decrease its effect.

Therefore, do not use other medications at the same time as zolpidem unless your doctor is informed and approves it in advance.

If you take zolpidem with the following medications, the effects may be potentiated, such as drowsiness or altered psychomotor function the next day, including impaired ability to drive.

•Medications for some mental disorders (antipsychotics)

•Medications for sleep disorders (hypnotics)

•Medications to relieve or reduce anxiety

•Medications for depression

•Medications for moderate to severe pain (narcotic analgesics)

•Medications for epilepsy

•Anesthetic medications

•Medications for seasonal allergic rhinitis, skin eruptions, or other allergies that may cause drowsiness (sedating antihistamines)

- If you take zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).

- Do not take zolpidem with fluvoxamine or ciprofloxacin.

- If you take zolpidem with narcotic analgesics, it may cause an increase in euphoria that may lead to an increase in psychological dependence.

- Opioid medications: The use of zolpidem at the same time as opioids (potent analgesics, substitution therapy medications, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal.Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes zolpidem along with opioids,the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all the opioid medications you are taking and follow your doctor's recommended dosing closely. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

- Some medications that inhibit/induce certain liver enzymes (CYP450) may affect the action of zolpidem.

- Concurrent administration with ketoconazole (used to treat fungal infections) may increase sedative effects.

- Concurrent administration with rifampicin (used to treat infections) and St. John's Wort may decrease the effect of zolpidem.

- Do not use zolpidem concomitantly with St. John's Wort, as it may decrease zolpidem blood levels.

- Do not use zolpidem concomitantly with medications containing alcohol. It may increase sedative effects.

Use of Zolpidem Stada with food, drinks, and alcohol

Avoid drinking alcoholic beverages during treatment. The effect of alcohol may potentiate sedation, and this may affect your ability to drive or use machinery. If you need additional information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Zolpidem is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor.

If used during pregnancy, there may be a risk to the fetus. Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.

Reduced fetal movement and variability in fetal heart rate may occur after taking zolpidem during the second and/or third trimester of pregnancy.

If zolpidem is taken at the end of pregnancy or during delivery, your baby may experience muscle weakness, decreased body temperature, difficulty feeding, and respiratory problems (respiratory depression).

If zolpidem is taken regularly at the end of pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.

Lactation

This medication passes into breast milk, so zolpidem should not be taken during breastfeeding.

Driving and using machines

Zolpidem is a medication that causes sleep. Do not drive or use machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Zolpidem has a significant effect on the ability to drive and use machinery, such as "driving while drowsy." The days you take zolpidem (as happens with other hypnotics) you should be aware of the following:

•You may feel drowsy, sleepy, dizzy, or confused

•You may take longer to make decisions

•You may experience blurred vision or double vision

•Your state of alertness may be reduced

To reduce the effects mentioned above, it is recommended to have a minimum of 8 hours between the administration of zolpidem and driving, using machinery, or any work that is performed at height.

Do not consume alcohol or any other psychoactive substance while taking zolpidem, as this may increase the effects mentioned above.

Zolpidem Stada contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Zolpidem Stada contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

-The recommended dose is 10 mg of zolpidem per 24 hours. A lower dose may be prescribed for some patients. Zolpidem should be taken:

•once; and

•just before going to bed.

Ensure that you leave a minimum of 8 hours between taking the medication and performing activities that require mental alertness.

Do not take more than 10 mg per 24 hours.

-In elderly patients, in debilitated patients, and in patients with liver disorders, the doctor will prescribe a lower dose.

The recommended daily dose is half a tablet, that is 5 mg of zolpidem.

-Children (under 18 years): not recommended for use

The treatment should start with the lowest dose. Do not exceed the maximum dose.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Take zolpidem just before going to bed and swallow the tablet without chewing it, with water or another non-alcoholic beverage.

Under normal conditions, it will not take more than 20 minutes to fall asleep after taking zolpidem, and it is advisable to ensure that you can rest without being woken up for at least 8 hours. Otherwise, although this occurs in rare cases, it is possible that you will not remember what happened while you were awake.

In most cases, only a short-term treatment with zolpidem is needed (usually not exceeding two weeks). The maximum duration of treatment is four weeks if the gradual withdrawal of the medication is included. Prolonging treatment will not be done without a reevaluation of your condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

To avoid withdrawal symptoms, do not stop taking zolpidem abruptly, especially if you have been taking it for a long time.

If you estimate that the effect of zolpidem is too strong or too weak, inform your doctor or pharmacist.

If you take more Zolpidem Stada than you should

If you have taken more zolpidem than you should, consult your doctor or pharmacist immediately.

In cases of overdose involving zolpidem alone or with other central nervous system depressants (including alcohol), cases have been reported ranging from altered consciousness to coma and more severe symptoms, including death.

In moderate cases, symptoms include: drowsiness, mental confusion, and a feeling of fatigue, exhaustion (lethargy). In more severe cases, symptoms may include: loss of coordination in movement (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of impaired consciousness up to coma, and more severe symptoms including a fatal outcome.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Zolpidem Stada

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Zolpidem Stada

Abruptly stopping treatment may produce withdrawal syndrome, which manifests as headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see section “Warnings and precautions”).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Most patients tolerate zolpidem well, but some, especially at the beginning of treatment, may feel a bit tired or drowsy during the day.

The following criterion has been used to classify the frequency of adverse reactions:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known: cannot be estimated from available data.

The relationship between side effects and dose has been demonstrated. These effects should be less if zolpidem is administered immediately before going to bed.

These effects are more frequent in elderly patients.

Immune system disorders

Frequency not known: allergic inflammation that can be located in feet, hands, throat, lips, and respiratory tracts (angioneuritic edema).

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.

Uncommon: confusional state, irritability, restlessness, aggression, somnambulism, euphoric mood. Zolpidem may cause somnambulism or other unusual behaviors while sleeping (such as driving, eating, calling, or having sex, etc.), without being fully awake, see "Warnings and precautions".

Rare: changes in sexual desire.

Very rare: delirium, dependence (stopping treatment may cause withdrawal symptoms or rebound effects).

Frequency not known: outbursts of anger, psychosis, abnormal behavior.

Nervous system disorders

Common: drowsiness, headache, dizziness, worsening of insomnia, cognitive disorders such as anterograde amnesia (does not remember what happened while awake after taking the medication). Amnesia may be associated with inappropriate behavior.

Uncommon: sensation of tingling, numbness (paresthesia), tremor, alteration of attention, speech disorder.

Rare: decreased level of consciousness.

Eye disorders

Uncommon: double vision, blurred vision. Rare: visual impairment.

Respiratory, thoracic, and mediastinal disorders

Very rare: respiratory difficulty (respiratory depression).

Gastrointestinal disorders

Common: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

Uncommon: increased liver enzymes.

Rare: liver damage (hepatocellular, cholestatic, or mixed injury).

Metabolism and nutrition disorders

Uncommon: appetite disorder.

Skin and subcutaneous tissue disorders

Uncommon: itching, skin rash, excessive sweating. Rare: urticaria.

Musculoskeletal and connective tissue disorders

Common: back pain.

Uncommon: joint pain (arthralgia), muscle pain (myalgia), muscle spasms, neck pain, muscle weakness

Infections and infestations

Common: respiratory tract infections (upper and lower respiratory tract infections).

General disorders and administration site conditions

Common: fatigue.

Rare: gait disturbances, falls (predominantly in elderly patients and when not following the doctor's recommendations).

Frequency not known: product tolerance.

Depression

The use of the medication may unmask an existing depression. Since insomnia can be a symptom of depression, if insomnia persists, inform your doctor to evaluate your situation.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zolpidem Stada

−The active ingredient is zolpidem tartrate. Each tablet contains 10 mg of zolpidem, as zolpidem tartrate.

−The other components are cellulose, lactose monohydrate, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide (E171), polyethylene glycol, polysorbate 80, and natural wax emulsion in aqueous base.

Appearance of the product and content of the packaging

Zolpidem Stada 10 mg are film-coated tablets, white, oblong, with rounded edges and scored on one face.

The score is only for breaking the tablet if it is difficult to swallow whole.

Each package contains 30 or 500 (clinical package) film-coated tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)
Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Last review date of thisleaflet:June 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/