Package Insert: Information for the User

Stilnox 10 mg Film-Coated Tablets

Zolpidem tartrate

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

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

6. Contents of the pack and additional information

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

Stilnox is used for the short-term treatment of insomnia in 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.

Stilnox 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 Stilnox

• If you are allergic to zolpidem or any other benzodiazepine or to any of the other ingredients in this medication (listed 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, as 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 Stilnox or other medications containing zolpidem.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Stilnox.

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

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

• If you have ever had any mental disorder or problems with substance abuse or dependence.

• Risk of dependence: The use of zolpidem may lead to the development of physical and psychological dependence. The risk of dependence is higher when Stilnox 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 substance abuse.

• To minimize the risk of dependence, consider the following precautions:

• The medication should be taken only under medical prescription (never because it has worked for other patients) and should not be recommended to others.
• Do not increase the prescribed doses or prolong the treatment longer than recommended.
• Consult your doctor regularly to decide if the treatment should continue.

Once physical dependence has developed, abrupt discontinuation of treatment will be accompanied by a withdrawal syndrome that may include 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, 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 discontinuing treatment, a transient syndrome may occur in which the symptoms that led to starting treatment reappear, but in an 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 caused by the appearance of these effects when discontinuing treatment. In the case of short-acting hypnotics/sedatives, the withdrawal syndrome may occur 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 your 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.

• Stilnox 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, discontinue Stilnox treatment immediately and contact your doctor or healthcare provider, as these sleep behaviors can put you and others at risk of serious injury.

Drinking alcohol or taking other sedating medications with Stilnox 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 discontinuing treatment in these cases, as the risk may be significant for both you and others.

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

• After repeated use for several weeks, some tolerance to the product may develop, resulting in a decrease in the effectiveness of the hypnotic effects.

• If you have a history of substance abuse or alcohol dependence, do not take Stilnox unless your doctor advises 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 disorders (psychosis), it is not recommended to use this medication as primary treatment.

• If you have suicidal tendencies and depression, use with extreme caution. Consult your doctor before using this medication, as it may unmask an existing depression.

Some studies have shown an increased 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 Stilnox or not.

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

• Do not take Stilnox at the same time as opioids (pain medications such as morphine or codeine) unless your doctor prescribes it, as there may be a risk of sedation, respiratory depression, coma, or even death (see "Use of Stilnox with other medications"). If your doctor eventually prescribes zolpidem with opioids, they should prescribe the minimum effective dose and for the shortest duration of concomitant use. Your doctor will monitor 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 old.

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

Like other hypnotics/sedatives, zolpidem has depressant effects on the central nervous system.

The next day after taking Stilnox, 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 alert mental.
• You take a higher dose than recommended.
• You take zolpidem with 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.

Do not take another dose during the same night.

Use of Stilnox 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 multiple medications may increase or decrease their effect.

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

• If you take zolpidem with the following medications, you may experience potentiated effects 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 for anxiety reduction
• 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 produce an increase in euphoria that could lead to an increase in psychological dependence.
• Opioid medications: The use of Stilnox with opioids (powerful pain medications, medication for substance substitution, and some medications for cough) increases the risk of sedation, 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 Stilnox with opioids, the dose and duration of concomitant use should be limited by your doctor.

Inform your doctor about all opioid medications you are taking and follow your doctor's recommended dosage. 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.
• The concomitant administration with ketoconazole (used to treat fungal infections) may increase sedative effects.
• The concomitant administration with rifampicin (used to treat infections) and with St. John's Wort may decrease the effect of zolpidem.
• Do not use St. John's Wort with zolpidem, as it may decrease blood levels of zolpidem.
• Do not use concomitantly with medications containing alcohol. It may increase sedative effects.

Use of Stilnox with food, drinks, and alcohol

During treatment, avoid drinking alcohol. 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, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Using Stilnox during pregnancy may pose 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 Stilnox during the second and/or third trimester of pregnancy.

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

If Stilnox is taken regularly near 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.

Breastfeeding

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

Driving and operating machines

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

Stilnox has a significant effect on the ability to drive and operate machinery, such as "driving in a somnolent state". The days you take Stilnox (as happens with other hypnotics) you should be aware of the following:

?You may feel drowsy, somnolent, 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, operating machinery, or any work that is performed at height.

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

Stilnox contains lactose

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

This medication contains less than 23 mg of sodium (1 mmol) 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 Stilnox every 24 hours. A lower dose may be prescribed for some patients. Stilnox should be taken:

• Once a day; and
• Just before going to bed.

Make sure to leave a minimum of 8 hours between taking the medication and performing activities that require mental alertness.

Do not take more than 10 mg every 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.

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

Under normal conditions, it should not take more than 20 minutes to fall asleep after taking Stilnox, 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 may not remember what happened while you were awake.

In most cases, only a short-term treatment with Stilnox 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 reevaluating 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 Stilnox abruptly, especially if you have been taking it for a long time.

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

If you take more Stilnox than you should

If you have taken more Stilnox 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 includediscoordination 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.

If you forgot to take Stilnox

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

If you interrupt treatment with Stilnox

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 doubts about the use of this medication, ask your doctor or pharmacist.

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

Most patients tolerate Stilnox 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 than1 in 10 patients

Common: may affect up to1 in 10 patients

Uncommon: may affect up to1 in 100 patients

Rare: may affect up to1 in 1,000 patients

Very rare: may affect up to1 in 10,000 patients

Unknown frequency: cannot be estimated from available data.

There is a demonstrated relationship between adverse effects and dose. These effects should be less if zolpidem is administered immediately before bedtime.

These effects are more frequent in elderly patients.

Immune system disorders

Unknown frequency: allergic inflammation that can be located infeet, hands, throat, lips, and respiratory tract (angioneurotic edema).

Mental health disorders

Common: hallucinations, agitation, nightmares, depression.

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

Rare: changes in sexual desire.

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

Unknown frequency: anger attacks, psychosis, abnormal behavior,delirium (a sudden and severe change in mental state that makes a person appear confused or disoriented).

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: tingling sensation, numbness (paresthesia), tremor, attention alteration, 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 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 infection (upper and lower respiratory tract infection).

General disorders and administration site conditions

Common: fatigue.

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

Unknown frequency: tolerance to the product.

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 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 theSpanish System for 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 medication.

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

No special storage conditions are required.

Expiration Date

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Stilnox 10 mg coated tablets

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

Appearance of the product and contents of the packaging

Stilnox is presented in the form of coated tablets, oblong, white, scored, with the inscription SN 10. The score is for dividing the tablet into two equal doses.

Packaging with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Responsible for manufacturing

Delpharm Dijon

6, Boulevard de l’Europe

21800 Quetigny (France)

or

Sanofi Winthrop Industrie

Avenue Gustave Eiffel, 30-36

37100 Tours (France)

Last review date of this leaflet: February 2022

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/