Zolpidem Normon 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Zolpidem Normon 10 mg film-coated tablets EFG

zolpidem tartrate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet Contents

1. What Zolpidem Normon is and what it is used for
2. What you need to know before taking Zolpidem Normon
3. How to take Zolpidem Normon
4. Possible adverse effects
5. How to store Zolpidem Normon
6. Contents of the pack and other information

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

Zolpidem Normon is a compound belonging to a group of medicines known as benzodiazepine-related drugs. It is used for the short-term treatment of sleep disorders in adults.

Zolpidem Normon is prescribed only for sleep disturbances that are severe, disabling, or causing the individual extreme distress.

2. What you need to know before taking Zolpidem Normon

Do not take Zolpidem Normon

• If you are allergic to zolpidem or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have experienced sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or engaging in sexual activity, etc.) while not fully awake after taking zolpidem or other medicines containing zolpidem.
• If you have severe muscle weakness (myasthenia gravis).
• If you experience interruptions in breathing for short periods while sleeping (sleep apnoea syndrome).
• If you have severe respiratory weakness (in which the lungs cannot take in enough oxygen) (respiratory insufficiency).
• If you have severe liver damage (hepatic insufficiency).

Children and young people under 18 years of age must not take zolpidem.

Do not take this medicine if any of the above situations apply to you. If you are unsure, speak with your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

- if you are an elderly or debilitated patient: you should take a lower dose (see section 3, how to take Zolpidem Normon). Zolpidem has a muscle-relaxing effect. For this reason, elderly patients, in particular, are at risk of falls and consequently of fractures when getting up from bed at night.

- if you have renal impairment. It may take longer to eliminate zolpidem from your body. Although dose adjustment is not required, caution is needed. Contact your doctor.

• if you have chronic respiratory problems (long-term). Your condition could worsen.
• if you have ever had heart problems, including slow or irregular heartbeat
• if you have ever had a mental disorder or have abused or been dependent on alcohol or drugs. You must be closely monitored by your doctor, as there is a risk of habituation and psychological dependence during treatment with zolpidem.
• if you have severe liver disease. You should not use zolpidem, as there is a risk of brain damage (hepatic encephalopathy). Contact your doctor.
• if you have delirium (psychosis), depression, or anxiety related to depression, zolpidem should not be the only treatment you receive.
• if you had another mental illness in the past.
• if you have or have ever had thoughts of harming yourself or of suicide. Some studies have shown an increased risk of suicidal ideation, suicide attempt, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.
• if you have recently taken zolpidem or other similar medicines for more than four weeks.

Zolpidem may cause drowsiness and reduce your level of alertness. This could lead to falls and, in some cases, result in serious injuries.

General

Before starting treatment with this medicine:

• The cause of the sleep disturbance must be clearly identified.
• Underlying medical conditions must be treated.

If treatment does not improve the sleep problem after 7–14 days of treatment, it may be due to a physical or psychiatric illness that needs to be evaluated. You should consult your doctor.

Psychomotor impairment the following day (see also “Driving and use of machines”)

The risk of psychomotor impairment the day after taking zolpidem, including impaired ability to drive, may be increased if:

• You take this medicine with less than 8 hours' gap before engaging in activities requiring mental alertness.
• You take a higher dose than recommended.
• You take zolpidem together with another central nervous system depressant or another medicine that increases the concentration of zolpidem in your blood, combined with alcohol or with illegal substances.

Take the dose as a single dose immediately before going to bed at night. Do not take another dose during the same night.

Abuse and/or physical or psychological dependence

Physical or psychological dependence may develop.

The risk increases with dose and duration of treatment, and is high in patients with a history of mental disorders, alcoholism, illicit substance use, or drug abuse. If physical dependence has developed, abrupt discontinuation of treatment is accompanied by withdrawal syndrome.

Memory disturbances (amnesia)

Zolpidem may cause memory loss (amnesia). This usually occurs several hours after taking zolpidem. To minimize this risk, you must ensure uninterrupted sleep for at least 8 hours (see section 4, Possible side effects).

Psychiatric and "paradoxical" reactions

Reactions such as nervousness, restlessness, irritability, aggressiveness, delirium (psychosis), rage, nightmares, hallucinations, sleepwalking, inappropriate behavior, increased sleep disturbances, and other adverse effects on behavior may occur.

If this happens, you must stop taking zolpidem and contact your doctor. These reactions are more likely to occur in elderly patients.

Sleepwalking and associated behaviors

Sleepwalking and associated behaviors have been reported, such as "sleep-driving," preparing food and eating, making telephone calls, or engaging in sexual activity, without memory of the episode, in patients who had taken zolpidem and were not fully awake. The use of alcohol and other central nervous system depressants together with zolpidem appears to increase the risk of these behaviors, as does exceeding the maximum recommended dose. If you experience any of these events, inform your doctor immediately, as these sleep-related behaviors may place you and others at serious risk of injury. Your doctor may recommend discontinuation of treatment.

Other medicines and Zolpidem Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription, including herbal medicines.

Zolpidem may affect other medicines. Conversely, these medicines may affect the action of zolpidem.

If you take zolpidem with the following medicines, effects such as drowsiness or psychomotor impairment the following day—including impaired driving ability—may be enhanced:

• Medicines for certain mental disorders (antipsychotics).
• Medicines for sleep problems (hypnotics).
• Medicines to relieve or reduce anxiety.
• Muscle relaxants (e.g., baclofen), as they may increase their muscle-relaxing effect.
• Medicines for depression.
• Medicines for moderate to severe pain (narcotic analgesics).
• Medicines for epilepsy.
• Anaesthetic medicines.
• Medicines for seasonal allergic rhinitis, skin rashes, or other allergies that may cause drowsiness (sedating antihistamines).

Zolpidem may interact with medicines used to treat various fungal infections, such as itraconazole and ketoconazole. Taking ketoconazole with zolpidem may increase the sedative effect.

Concomitant use of zolpidem and opioids (strong analgesics, medicines for substitution therapy, 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 no other treatment options are possible.

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

Inform your doctor about all opioid medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform friends or family members so they can be alert for the signs and symptoms described above. Contact your doctor if you experience these symptoms.

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

Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.

Medicines that strongly increase the activity of certain liver enzymes may possibly reduce the effect of zolpidem, e.g., rifampicin (an antibiotic used to treat infections), carbamazepine and phenytoin (medicines used to treat seizures), and St. John’s wort (a herbal medicine used for mood changes and depression). Concomitant use is not recommended.

Taking Zolpidem Normon with alcohol

You must not drink alcohol during treatment. Alcohol may enhance the effects of zolpidem, causing you to sleep so deeply that you do not breathe properly or have difficulty waking up.

Drinking alcohol during treatment may impair your ability to drive or operate machinery.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Zolpidem Normon must not be taken during pregnancy and breastfeeding, especially during the first three months of pregnancy, because there is insufficient information available to ensure the safety of this medicine during pregnancy and breastfeeding.

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

If zolpidem is taken towards the end of pregnancy or during childbirth, your baby may show muscle weakness, lowered body temperature, feeding difficulties, and breathing problems (respiratory depression).

However, if the benefit to the mother outweighs the risk to the baby, your doctor may decide to treat you with zolpidem. If zolpidem is taken over a prolonged period during the last months of pregnancy, your baby may develop physical dependence and may be at risk of withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.

Zolpidem passes into breast milk in small amounts; therefore, zolpidem should not be taken during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Zolpidem has a significant effect on the ability to drive and use machines. On days when you take zolpidem (as with other hypnotics), you should consider the following:

• You may feel drowsy, sleepy, dizzy, or confused.
• You may take longer to make decisions.
• You may experience blurred or double vision.
• Your alertness may be reduced.

To reduce the aforementioned effects, a minimum interval of 8 hours between administration of zolpidem and driving, operating machinery, or performing any work at heights is recommended.

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

For more information on possible adverse effects that could affect your ability to drive, see section 4 of this leaflet.

Zolpidem Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; thus, it is essentially “sodium-free.”

3. How to take Zolpidem Normon

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Zolpidem should be taken:

• as a single dose;
• just before going to bed;
• ensure you have a period of at least 8 hours after taking this medicine before carrying out activities requiring alertness;
• do not exceed 10 mg in 24 hours;
• administer the medicine orally;
• swallow the tablet with a glass of water.

The recommended dose is:

Adults

The recommended dose is one 10 mg zolpidem tartrate tablet every 24 hours. A lower dose may be prescribed for some patients.

Elderly patients, debilitated patients, or patients with hepatic impairment

A lower dose is recommended, starting at 5 mg per day (half a 10 mg zolpidem tablet). Your doctor may increase your dose to 10 mg if the effect is insufficient and if the medicine is well tolerated.

Use in children and adolescents

Zolpidem must not be used in children and adolescents under 18 years of age.

Maximum dose

Do not take more than 10 mg (2 film-coated tablets of Zolpidem Normon 5 mg or 1 film-coated tablet of Zolpidem Normon 10 mg) every 24 hours.

Zolpidem tartrate 5 mg tablets are also available.

Duration of treatment

The sleep-promoting (hypnotic) effect may be reduced after repeated treatment over several weeks.

The duration of treatment should be as short as possible. It may range from a few days to 2 weeks, and should not exceed four weeks.

In certain situations, taking zolpidem for a longer period may be required. Your doctor will inform you when and how to stop the treatment.

If you take more Zolpidem Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested. Do not go to the hospital alone; ask someone else to accompany you. Bring this leaflet with you and any remaining tablets to show to the doctor.

This is so the doctor knows what you have taken. Taking too much zolpidem can be very dangerous. The following effects may occur: feeling drowsy, confused, sleeping deeply, and possibly falling into a fatal coma.

If you forget to take Zolpidem Normon

Do not take a double dose to make up for missed doses. Take the tablet only if you will be able to sleep for 8 hours. If this is not possible, do not take the tablet until you go to bed the following day.

If you stop taking Zolpidem Normon

Keep taking zolpidem until your doctor tells you to stop. Do not stop taking zolpidem suddenly, but inform your doctor if you wish to discontinue it. Your doctor should gradually reduce your dose and discontinue your tablets over a period of time.

If you stop taking zolpidem suddenly, your sleep problems may return and you may experience a "withdrawal effect." If this happens, you may suffer some of the following effects:

• Feeling anxious, restless, irritable, or confused.
• Headache.
• Faster or irregular heartbeat (palpitations).
• Nightmares, seeing or hearing things that are not real (hallucinations).
• Becoming more sensitive than normal to light, noise, and touch.
• Loss of contact with reality.
• Feeling detached from your body or feeling "like a puppet."
• Numbness and tingling in hands and feet.
• Muscle pain.
• Stomach problems.
• Sleep difficulties returning worse than before.
• In rare cases, seizures (fits) may also occur.

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

4. Possible adverse effects

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

These effects appear to be related to individual sensitivity and seem to occur more frequently within the first hour after taking the tablet if the person does not go to bed or fall asleep immediately.

Adverse effects occur more frequently in elderly patients.

Stop taking zolpidem and consult a doctor or go to the hospital immediately if:

• You have an allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

Other adverse effects are:

Frequent (may affect up to 1 in 10 people)

• perception of things that are not real (hallucinations), agitation, nightmares,
• depression,
• drowsiness the following day, emotional blunting, reduced alertness, attention disturbance, fatigue, headache, dizziness, difficulty remembering things, which may be associated with inappropriate behavior (see section 2, Warnings and precautions), memory impairment, inability to recall recent events (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia,
• sensation of dizziness with loss of balance (vertigo),
• lung or respiratory tract infection (respiratory infection),
• diarrhea, feeling unwell (nausea), vomiting, stomach pain,
• back pain,
• fatigue.

Uncommon (may affect up to 1 in 100 people)

• confusion, irritability,
• sleepwalking, feeling of intense euphoria or confidence (euphoria), feeling restless or angry,
• difficulty speaking, attention disturbance, tremor,
• double vision, blurred vision,
• change in appetite (appetite disorder),
• increased liver enzymes,
• unusual sensation or tingling of the skin, skin itching or rash, excessive sweating,
• joint or muscle pain, muscle spasms, weak muscles, neck pain.

Rare (may affect up to 1 in 1,000 people)

• change in sexual desire (libido),
• liver injury (hepatocellular, cholestatic or mixed),
• hives,
• abnormal walking posture (abnormal gait).

Very rare (may affect up to 1 in 10,000 people)

• decreased ability to see (visual impairment),
• physical or psychological dependence. If you stop taking Zolpidem Normon suddenly, you may experience withdrawal symptoms (see section 2, Warnings and precautions),
• thinking things that are not true (delusions),
• slower breathing (respiratory depression).

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

• rapid swelling beneath the skin in areas such as the face, throat, arms and legs, which may be life-threatening if swelling of the throat blocks the airways (angioedema),
• a drug effect that is opposite to what is normally expected (paradoxical reaction), abnormal behavior, mental disorders (psychosis), anger; these reactions are more likely in elderly patients,
• misuse of zolpidem has been reported by drug abusers, reduced awareness of surroundings,
• drug tolerance, falls (mainly in elderly patients and when zolpidem is not taken as prescribed),
• delirium (a sudden and severe change in mental state causing confusion or disorientation).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolpidem Normon

This medicine does not require any special storage conditions. Store in the original packaging.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolpidem Normon

• The active substance is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
• The other components (excipients) are:
• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylstarch type A (from potato), hypromellose, and magnesium stearate.
• Film coating: hypromellose, titanium dioxide (E 171), talc, and macrogol 6000.

Appearance of the product and contents of the pack

Zolpidem Normon 10 mg are white or almost white, round, biconvex, film-coated tablets, with "Z" printed on one side and scored on the other. They are available in packs containing 28, 30 and 500 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the most recent review of this leaflet: September 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.