Stilnox 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Stilnox 10 mg film-coated tablets

Zolpidem tartrate

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

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

Contents of this leaflet:

1. What Stilnox is and what it is used for

2. What you need to know before taking Stilnox

3. How to take Stilnox

4. Possible side effects

5. How to store Stilnox

6. Contents of the pack and other information

1. What Stilnox is and what it is used for

Stilnox is a hypnotic medicine belonging to a group of medicines known as benzodiazepine analogues.

Stilnox is used for the short-term treatment of insomnia in patients over 18 years of age, in situations where insomnia is disabling or causing severe anxiety.

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

Stilnox is indicated for sleep-rhythm disorders and for all forms of insomnia, particularly when there are difficulties in falling asleep, either initially or after early awakening.

2. What you need to know before taking Stilnox

Do not take Stilnox

• If you are allergic to zolpidem or to benzodiazepines in general, or to any of the other ingredients of this medicine (listed in section 6).

• If you have acute and/or severe breathing difficulties.

• If you suffer from breathing problems during sleep (sleep apnea syndrome).

• If you have muscle weakness or fatigue (myasthenia gravis).

• If you have severe liver problems (hepatic impairment).

• As a long-term treatment. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.

• If you have previously experienced sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or engaging in sexual activity) while not fully awake, after taking Stilnox or other medications containing zolpidem.

Warnings and precautions

Talk to your doctor or pharmacist before taking Stilnox.

• Your doctor should identify the underlying causes of insomnia whenever possible and address any contributing factors before prescribing zolpidem.

• After taking Stilnox, ensure that you can have an uninterrupted 8-hour sleep period to reduce the risk of anterograde amnesia (not remembering events that occurred while you were awake).

• If you have ever had a mental disorder or a history of alcohol or drug abuse or dependence.

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

• To minimize the risk of dependence, the following precautions should be observed:

• These medicines should only be taken under medical prescription (never because they worked for someone else), and should never be recommended to others.

• Do not increase the prescribed dose or extend treatment beyond the recommended duration.

• Consult your doctor regularly so they can determine whether treatment should continue.

Once physical dependence has developed, abruptly stopping treatment may lead to withdrawal symptoms such as restlessness, anxiety, headache, muscle pain, confusion, irritability, and tension. Therefore, it is recommended to gradually reduce the dose according to your doctor's instructions.

In severe cases, the following symptoms may occur: altered perception of reality, depersonalization, reduced tolerance to usual sounds (hyperacusis), 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 more intensely. These may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. It is important to be aware that this rebound phenomenon may occur, in order to minimize anxiety related to the emergence of these effects when stopping treatment. For short-acting hypnotic/sedative drugs, withdrawal symptoms may appear within the dosing interval. The likelihood of rebound insomnia is higher with abrupt discontinuation. Therefore, it is recommended to gradually reduce the dose, according to your doctor's instructions.

• Other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggressiveness, delirium, rage attacks, nightmares, psychosis, hallucinations, abnormal behavior, and other behavioral disturbances have been reported with zolpidem. Treatment should be discontinued if these reactions occur. These reactions are more likely to occur in elderly patients.

• Stilnox may cause sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or engaging in sexual activity) while not fully awake, some of which have been associated with serious injuries or even death. The following morning, you may not remember anything you did during the night. If you experience any of these symptoms, stop taking Stilnox immediately and contact your doctor or healthcare provider, as these sleep-related behaviors may pose a serious risk of injury to yourself and others.

Drinking alcohol or taking other medicines that cause drowsiness together with Stilnox may increase the risk of these sleep-related behaviors.

Using zolpidem with alcohol or other medicines that act on the central nervous system, or taking higher than the recommended dose, may increase the risk of these behaviors. Your doctor should consider discontinuing treatment in such cases due to the potential risk to you and others.

• This medicine may cause drowsiness and reduced consciousness, which may lead to falls and consequently cause serious injuries.

• After repeated use over several weeks, tolerance to the product may develop, leading to a reduction in the hypnotic effect.

• If you have a history of drug or alcohol dependence, you should not take Stilnox unless specifically instructed by your doctor.

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

• In patients with mental illnesses (psychosis), its use is not recommended as primary treatment.

• If you have suicidal tendencies or depression, zolpidem should be used with extreme caution. Consult your doctor before using this medicine, as it may unmask pre-existing depression.

Some studies have shown an increased risk of suicidal ideation, suicide attempts, and suicide in patients taking certain sedative and hypnotic medicines, including this one. However, it has not been established whether this is caused by the medicine or whether there may be other reasons. If you experience suicidal thoughts, contact your doctor as soon as possible for further medical advice.

- If you have any liver disorder or respiratory problems, your doctor will decide whether it is appropriate for you to take a lower dose of Stilnox or not to take it at all.

• In patients with severe hepatic insufficiency, Stilnox should not be taken, as it may contribute to the development of encephalopathy (brain disease).

• Do not take Stilnox concomitantly with opioids (medicines used to relieve severe pain, such as morphine or codeine) unless prescribed by your doctor, due to the potential risk of sedation, respiratory depression, coma, or even death (see "Use of Stilnox with other medicines"). If your doctor does prescribe zolpidem together with opioids, the lowest effective dose should be prescribed for the shortest possible duration of concomitant use. Your doctor will monitor you for signs and symptoms of respiratory depression and sedation.

• In elderly patients, the dose should be reduced. See section 3, "How to take Stilnox".

• Children and adolescents: Stilnox is not recommended for children and adolescents under 18 years of age.

Next-day psychomotor impairment (see also “Driving and use of machines”)

Like other hypnotic/sedative medicines, zolpidem has central nervous system depressant effects.

The risk of next-day psychomotor impairment, including impaired driving ability, may be increased the day after taking Stilnox if:

• You take this medicine with less than 8 hours' time before engaging in activities requiring mental alertness
• You take a higher dose than the recommended dose
• You take zolpidem together with another central nervous system depressant or another medicine that increases zolpidem blood levels, 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.

Taking Stilnox with other medicines

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

This is extremely important because taking more than one medicine at the same time may increase or decrease its effect.

Therefore, you should not take other medicines together with Stilnox unless your doctor is aware and has approved it in advance.

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

• Medicines for certain mental disorders (antipsychotics)

• Medicines for sleep disorders (hypnotics)

• Medicines to relieve or reduce anxiety

• 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)

• 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.

• If you take zolpidem with narcotic analgesics, increased euphoria may occur, which could lead to increased psychological dependence.

• Opioid medicines: Using Stilnox together with opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Stilnox together 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 closely follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

• Some medicines that inhibit/induce certain liver enzymes (CYP450) may affect the action of zolpidem.
• Concomitant administration with ketoconazole (used to treat fungal infections) may increase sedative effects.
• Concomitant administration with rifampicin (used to treat infections) and St. John’s wort may reduce the effect of zolpidem.
• Concurrent use of zolpidem with St. John’s wort is not recommended, as it may reduce zolpidem blood levels.
• Concomitant use with medicines containing alcohol is not recommended. This may increase the sedative effect.

Taking Stilnox with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which could affect your ability to drive or operate machinery. If you need further information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Use of Stilnox during pregnancy is not recommended. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor.

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

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

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

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

Breastfeeding

This medicine passes into breast milk; therefore, Stilnox should not be taken during breastfeeding.

Driving and use of machines

Stilnox is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or notice that your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased.

Stilnox has a significant effect on the ability to drive and operate machinery, such as "driving while drowsy." On days when you take Stilnox (as with other hypnotics), you should consider the following:

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

? It may take you longer to make decisions

? You may experience blurred or double vision

? Your level of alertness may be reduced.

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

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

Stilnox contains lactose

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

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

3. How to take Stilnox

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

• The recommended dose is 10 mg of Stilnox every 24 hours. A lower dose may be prescribed for some patients. Stilnox should be taken:

• as a single dose; and

• immediately before going to bed.

You must ensure that you allow a minimum of 8 hours between taking the medicine and engaging in activities requiring mental alertness.

Do not take more than 10 mg every 24 hours.

• In elderly patients, weakened patients, and patients with liver disorders, your doctor will prescribe a lower dose.

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

• Children (under 18 years): use is not recommended.

Treatment should be started with the lowest dose. The maximum dose must not be exceeded.

Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless your doctor prescribes a higher dose.

Take Stilnox immediately before going to bed, swallowing the tablet whole with water or another non-alcoholic drink.

Under normal circumstances, you should fall asleep within 20 minutes after taking Stilnox, and it is advisable to ensure you can rest undisturbed for at least 8 hours. Otherwise, although this occurs only rarely, you may not remember events that occurred while you were awake.

In most cases, only short-term treatment with Stilnox is needed (generally no longer than two weeks). The maximum duration of treatment is four weeks, including gradual withdrawal. Treatment extension should not occur without re-evaluation of your condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

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

If you feel that the effect of Stilnox is too strong or too weak, tell your doctor or pharmacist.

If you take more Stilnox than you should

If you have taken more Stilnox than you should, contact your doctor or pharmacist immediately.

In overdose cases involving zolpidem alone or in combination with other central nervous system depressants (including alcohol), reports have ranged from altered consciousness to coma and more severe symptoms, including death.

In moderate cases, symptoms include: drowsiness, mental confusion, and feelings of tiredness, exhaustion (lethargy). In more severe cases, symptoms may include lack of coordination in movement (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, impaired consciousness progressing to coma, and more severe symptoms including fatal outcomes.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Stilnox

Do not take a double dose to make up for missed doses.

If you stop treatment with Stilnox

Abrupt discontinuation of treatment may cause withdrawal syndrome, manifested by headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see section “Warnings and precautions”).

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

4. Possible adverse effects

Like all medicines, Stilnox may cause adverse effects, although not everyone experiences them.

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

The following classification has been used for 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.

A dose-dependent relationship with adverse effects has been established. These effects should be minimized if zolpidem is taken immediately before going to bed.

These effects are more frequent in elderly patients.

Immune system disorders

Frequency not known: allergic inflammation that may occur in the feet, hands, throat, lips, and respiratory tract (angioedema).

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.
Uncommon: confusional state, irritability, restlessness, aggression, sleepwalking, euphoric mood. Stilnox may cause sleepwalking or other unusual behaviors while asleep (such as driving, eating, making phone calls, or engaging in sexual activity) while not fully awake—see section “Warnings and precautions”.
Rare: changes in sexual desire.
Very rare: delirium, dependence (stopping treatment may lead to withdrawal symptoms or rebound effects).
Frequency not known: rage attacks, psychosis, abnormal behavior, delirium (a sudden and severe change in mental state causing confusion or disorientation).

Nervous system disorders

Common: drowsiness, headache, dizziness, worsening of insomnia, cognitive disorders such as anterograde amnesia (inability to remember events that occurred after taking the medicine). Amnesia may be associated with inappropriate behavior.
Uncommon: tingling sensation, numbness (paresthesia), tremor, attention disturbance, speech disorder.
Rare: decreased level of consciousness.

Eye disorders

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

Respiratory, thoracic and mediastinal disorders

Very rare: breathing 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 disturbance.

Skin and subcutaneous tissue disorders

Uncommon: itching, 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 infection (upper and lower respiratory tract infection).

General disorders and administration site conditions

Common: fatigue.
Rare: gait disturbance, falls (predominantly in elderly patients and when physician recommendations have not been followed).
Frequency not known: tolerance to the product.

Depression

Use of this medicine may unmask an underlying depression. Since insomnia may be a symptom of depression, if insomnia persists, inform your doctor so your condition can be evaluated.

Reporting of adverse effects

If you experience any 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 Stilnox

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Expiry

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Stilnox 10 mg film-coated tablets

• The active substance is zolpidem tartrate. Each tablet contains 10 mg of zolpidem as zolpidem tartrate.
• The other components are: monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (Type A) from potato, magnesium stearate, titanium dioxide (E-171), macrogol 400.

Appearance of the product and contents of the pack

Stilnox is presented as film-coated, oblong, white tablets, scored, with the imprint SN 10. The score is intended to facilitate breaking the tablet into two equal parts.

Pack containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder sanofi-aventis, S.A. C/ Rosselló i Porcel, 21 08016 Barcelona Spain

Manufacturer

Delpharm Dijon
6, Boulevard de l’Europe
21800 Quetigny (France)

or

Sanofi Winthrop Industrie
Avenue Gustave Eiffel, 30-36
37100 Tours (France)

Date of the most recent review of this leaflet: February 2022

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