Product Information for the User

Zolpidem Normon 5 mg Film-Coated Tablets EFG

zolpidem tartrate

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

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

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

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

3. How to take Zolpidem Normon

4. Possible side effects

5. Storage of Zolpidem Normon

6. Contents of the pack and additional information

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

Zolpidem is only prescribed for severe, debilitating, or extremely distressing sleep disturbances.

Do not take Zolpidem Normon

• If you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• 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 medicines containing zolpidem. If you have severe muscle weakness (myasthenia gravis).
• If your breathing is interrupted for short periods while sleeping (sleep apnea syndrome).
• If you have severe respiratory weakness (in which the lungs cannot take in enough oxygen) (respiratory insufficiency).
• If you have severe liver damage (liver insufficiency).

Children and young people under 18 years should not take zolpidem.

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

Warnings and precautions

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

• if you are elderly or weak: 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 subsequent hip fractures when getting up from bed at night.
• if you have kidney problems. You may take longer to eliminate zolpidem. Although no dose adjustment is required, caution is needed. Contact your doctor.
• if you have chronic respiratory problems (long-term). Your problems may worsen.
• if you have ever had heart problems, including slow or irregular heartbeats.
• if you have ever had a mental disorder or have abused or been dependent on alcohol or drugs. You should be carefully 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 (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 have had another mental illness in the past.
• if you have or have ever had thoughts of harming yourself or attempting suicide. Some studies have shown a higher risk of suicidal ideation, suicide attempts, 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 taken zolpidem or other similar medicines for more than four weeks recently.

Zolpidem may cause drowsiness and decrease your level of alertness. This could cause a fall and, in some cases, cause serious injuries.

General

Before starting treatment with this medicine:

• the cause of the sleep disturbance should be clear.
• underlying diseases should be treated.

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

Altered psychomotor function the next day (see also “Driving and operating machines”)

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

• You take this medicine with less than 8 hours of margin before performing activities that require a state of mental alertness.
• You take a higher dose than recommended.
• You take zolpidem at the same time as another central nervous system depressant or another medicine that increases the concentration of zolpidem in your blood, combined with alcohol or with illicit substances.

Take the dose once and 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 the dose and duration of treatment and is high in patients with a history of mental disorders, alcoholism, illicit substances, or drug use. If physical dependence has developed, abrupt discontinuation of treatment is accompanied by withdrawal syndrome.

Memory alterations (amnesia)

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

Psychiatric and “paradoxical” reactions

It is known that reactions such as nervousness, restlessness, irritability, aggression, delirium (psychosis), anger, nightmares, hallucinations, sleepwalking, inappropriate behavior, increased sleep disturbances, and other adverse effects on behavior may occur.

If this occurs, you should discontinue taking zolpidem and contact your doctor. It is more likely that these reactions will occur in elderly patients.

Sleepwalking and associated behaviors

Sleepwalking and associated behaviors such as “driving asleep”, preparing food and eating, making phone calls, or having sex, without remembering the episode in patients who had taken zolpidem and were not fully awake have been reported. The use of alcohol and other central nervous system depressants with zolpidem appears to increase the risk of these behaviors, or if you exceed the maximum recommended dose. If you experience any of these events, inform your doctor immediately as these sleep behaviors can put you and others at risk of serious injuries. Your doctor may recommend discontinuing treatment.

Other medicines and Zolpidem Normon

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

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

If you take zolpidem with the following medicines, you may see potentiated effects such as drowsiness or altered psychomotor function the next day, including altered ability to drive:

• Medicines for some mental disorders (antipsychotics).
• Medicines for sleep disorders (hypnotics).
• Medicines to relieve or reduce anxiety.
• Muscle relaxants (e.g. baclofen), as it may increase its muscle-relaxing effect.
• Medicines for depression.

• Medicines for moderate to severe pain (narcotic analgesics).
• Medicines for epilepsy.
• Anesthetics.
• Medicines for seasonal allergic rhinitis, skin eruptions, or other allergies that may cause drowsiness (sedating antihistamines).

Zolpidem may interact with medicines to treat a variety of fungal infections such as itraconazole and ketoconazole. Taking ketoconazole with zolpidem may increase the sedative effect.

The concomitant use of zolpidem and opioids (strong analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma and may put your life at risk. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

Inform your doctor about all the opioid medicines you are taking and follow your doctor's recommended dose strictly. It may be helpful to inform friends or family members to alert them to 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).

Zolpidem should not be taken with fluvoxamine or ciprofloxacin.

Medicines that significantly increase the activity of certain liver enzymes may reduce the effect of zolpidem, such as rifampicin (an antibiotic used to treat infections), carbamazepine, and phenytoin (medicines used to treat seizures), and St. John's Wort (a plant-based medicine for mood changes and depression). Concomitant use is not recommended.

Taking Zolpidem Normon with alcohol

You should not drink alcohol during treatment. Alcohol may increase the effects of zolpidem and make you sleep deeply, so you may not breathe properly or have difficulty waking up.

Drinking alcohol during treatment may affect your ability to drive or operate machines.

Pregnancy and breastfeeding

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

Zolpidem should not be taken during pregnancy and breastfeeding,especially during the first three months of pregnancy because there is not enough information available to guarantee the safety of this medicine during pregnancy and breastfeeding.

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 show muscle weakness, decreased body temperature, difficulty feeding, and respiratory problems (respiratory depression).

However, if the benefit to the mother is greater than the risk to the baby, your doctor may decide to treat you with zolpidem. If zolpidem is taken for a longer 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 baby should be closely monitored during the postnatal period.

Zolpidem passes into breast milk in small amounts, so you should not take zolpidem during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Zolpidem has a significant effect on your ability to drive and operate machines. The days you take zolpidem (as 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 or double vision.
• Your level of alertness may be decreased.

To reduce the effects mentioned above, it is recommended to have a minimum of 8 hours between taking zolpidem and driving, operating machines, 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.

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

Zolpidem Normon contains lactose

This medicine contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medicine.

Zolpidem Normon contains sodium

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

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

Zolpidem should be taken:

• as a single dose;
• just before going to bed;
• make sure to have a period of at least 8 hours after taking this medication before performing activities that require being alert;
• do not exceed 10 mg per 24 hours;
• administer the medication orally;
• swallow the tablet with a glass of water.

The recommended dose is:

Adults

The recommended dose is 10 mg per 24 hours. A lower dose may be prescribed for some patients.

Older patients, weakened patients or patients with liver insufficiency

A lower dose of 5 mg per day is recommended at the beginning of treatment (one 5 mg film-coated tablet). Your doctor may increase your dose to 10 mg (2 film-coated tablets of 5 mg Zolpidem tartrate) if the effect is insufficient and the medication is well tolerated.

Use in children and adolescents

Zolpidem should not be used in children or adolescents under 18 years of age.

Maximum dose

Do not take more than 10 mg (2 film-coated tablets of 5 mg zolpidem or 1 film-coated tablet of 10 mg zolpidem) per 24 hours. There are 10 mg zolpidem tartrate tablets available.

Treatment duration

The hypnotic effect may be reduced after repeated treatment for several weeks.

The treatment duration should be as short as possible. It may range from a few days to 2 weeks, and should not exceed 4 weeks.

In certain situations, zolpidem may need to be taken for a longer period. Your doctor will inform you when and how to interrupt 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Do not go to the hospital alone, ask someone to accompany you. Bring this leaflet with you and any remaining tablets to show them to your doctor.

This is so that 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 suffering a fatal coma.

If you forgot to take Zolpidem Normon

Do not take a double dose to compensate for the missed doses. Take the tablet if you will be able to sleep 8 hours. If this is not possible, do not take the tablet until the next night.

If you interrupt treatment with Zolpidem Normon

Continue taking zolpidem until your doctor tells you to stop. Do not stop taking zolpidem suddenly, but inform your doctor if you want to stop. Your doctor should reduce your dose and discontinue your tablets for a period of time.

If you stop taking zolpidem suddenly, your sleep problems may recur and you may experience withdrawal symptoms. If this happens, you may experience some of the following effects.

Consult a doctor immediately if you experience any of the following effects:

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.

These side effects seem to be related to individual sensitivity and seem to be more frequent after the first hour of taking the tablet if you do not go to bed or sleep immediately.

Side effects occur more frequently in elderly patients.

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

Other side effects are:

Frequent(may affect up to 1 in 10 people):

• perception of things that are not real (hallucinations), agitation, nightmares;
• depression;
• daytime drowsiness, emotional numbness, reduced alertness, attention alteration, fatigue, headache, dizziness, difficulty remembering things, which may be associated with inappropriate behavior, (see section 2, Warnings and precautions), memory deterioration, inability to remember 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 of discomfort (nausea), vomiting, stomach pain;
• back pain;
• fatigue.

Rare(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 alteration, tremor;
• double vision, blurred vision;
• change in appetite (appetite disorder);
• increase in liver enzymes;
• unusual sensation or tingling in the skin, skin itching or rash, excessive sweating;
• joint or muscle pain, muscle spasms, weak muscles, neck pain.

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

• change in sexual desire (libido);
• liver damage (hepatocellular, cholestatic, or mixed);
• rash;
• abnormal gait (abnormal gait).

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

• vision impairment (visual disability);
• physical or psychological dependence. If you stop taking zolpidem 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(the frequency cannot be estimated from the available data)

• rapid inflammation under the skin in areas such as the face, throat, arms, and legs that can be life-threatening if the throat inflammation blocks the airways (angioedema);
• a drug effect that is contrary to what is normally expected (paradoxical reaction), abnormal behavior, mental disorders (psychosis), anger, these reactions are more likely in the elderly;
• abuse of zolpidem by drug addicts, being less aware of your surroundings;
• tolerance to drugs, falls (mainly in elderly patients and when zolpidem was not taken as prescribed);
• delirium (a sudden and severe change in mental state that makes a person appear confused or disoriented.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Zolpidem Normon

• The active ingredient is zolpidem tartrate. Each tablet contains 5 mg of zolpidem as zolpidem tartrate.
• The other components (excipients) are:

Tablet core:monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethylcellulose type A (from potato), magnesium stearate.

Coating of the tablets with a film: hypromellose, talc, and macrogol 6000.

Appearance of the product and contents of the packaging

Zolpidem Normon is presented in the form of film-coated tablets, round, biconvex, white, with a diameter of 5.1 mm, and marked with “Z” on one face and anonymous on the other.

Zolpidem Normon is available in packaging containing 30 tablets in aluminum/PVC blisters.

Holder of the marketing authorization and responsible for manufacturing.

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:August 2024

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