STILNOX 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
3. Stilnox
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Stilnox and what is it used for
5. Important information before taking Stilnox
   1. Do not take Stilnox if:
   2. Warnings and precautions
   3. Children and adolescents
   4. Stilnox and other medicines
   5. Stilnox with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
   8. Stilnox contains lactose monohydrate
   9. Stilnox contains sodium
6. How to take Stilnox
   1. Overdose of Stilnox
   2. Missed dose of Stilnox
   3. Discontinuation of Stilnox
7. Possible side effects
   1. Reporting side effects
8. How to store Stilnox
9. Package contents and other information
   1. What Stilnox contains
   2. What Stilnox looks like and contents of the package
   3. Marketing authorization holder in Romania, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 632/15

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Stilnox

10 mg, coated tablets
Zolpidem tartrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Stilnox and what is it used for
• 2. Important information before taking Stilnox
• 3. How to take Stilnox
• 4. Possible side effects
• 5. How to store Stilnox
• 6. Package contents and other information

1. What is Stilnox and what is it used for

Stilnox is available in the form of coated tablets and contains the active substance zolpidem.
Zolpidem belongs to a group of sedative and hypnotic medicines.
The medicine facilitates falling asleep, reduces the number of nighttime awakenings, prolongs sleep duration, and improves its quality.
Stilnox is used for short-term treatment of insomnia in patients over 18 years of age when insomnia causes significant impairment or distress for the patient.
Do not use for a long time. Treatment should last as short as possible, as the risk of dependence increases with the duration of treatment.

2. Important information before taking Stilnox

Do not take Stilnox if:

• you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6)
• you have severe liver impairment
• you have sleep apnea syndrome
• you have acute or severe respiratory failure
• you have myasthenia gravis
• you are taking long-term therapy. Treatment should last as short as possible, as the risk of dependence increases with the duration of treatment.
• you have ever experienced sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or having sex, etc.) when you did not wake up completely after taking Stilnox or another medicine containing zolpidem.

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Warnings and precautions

Before starting treatment with Stilnox, discuss it with your doctor or pharmacist.
In each case, try to determine the causes of insomnia and, if possible, eliminate the factors that cause it before the doctor recommends taking a sedative.
Persistent insomnia after 7-14 days of treatment may indicate the existence of primary mental or physical disorders that require diagnosis and evaluation by a doctor at regular intervals.
Respiratory failure:
Since sedatives can inhibit respiratory center activity, caution should be exercised when taking Stilnox in patients with respiratory function disorders (see section 4).
Liver function disorders:
Liver function disorders - see section 3. How to take Stilnox:
In patients with severe liver impairment, Stilnox should not be taken. Taking Stilnox in patients with severe liver impairment may lead to encephalopathy - a disorder of the central nervous system caused by liver failure (see section 2. Important information before taking Stilnox).
Older or weakened patients:
Older or weakened patients should take a lower dose of the medicine, see section 3.
Mental illnesses:
Sedatives, such as Stilnox, are not recommended for initial treatment of mental illnesses.
Psychomotor disorders the next day (see also "Driving and operating machinery"):
Like other sedatives, zolpidem has a central nervous system depressant effect.
The next day after taking Stilnox, the risk of psychomotor disorders, including impaired driving ability, may be increased if:

• The patient took the medicine less than 8 hours before activities that require increased alertness
• The patient took a higher dose than recommended
• The patient took zolpidem while being treated with other central nervous system depressants or other medicines that increase zolpidem levels in the blood, while consuming alcohol, or while taking prohibited substances

Take a single dose directly before bedtime.
Do not take another dose on the same night.
Amnesia:
Sedatives and hypnotics can cause anterograde amnesia. It usually occurs a few hours after taking the medicine. To reduce the risk, the patient should have the opportunity for uninterrupted sleep lasting 8 hours.
Suicidal thoughts, suicide attempts, suicide, and depression:
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been determined whether this is caused by taking the medicine or other factors. If the patient has suicidal thoughts, they should contact their doctor as soon as possible to receive medical advice.
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Although no clinically significant interactions have been found between zolpidem and selective serotonin reuptake inhibitors (see section: Stilnox and other medicines) and other sedatives and hypnotics, caution should be exercised when taking zolpidem as well as other sedatives and hypnotics in patients with symptoms of depression.
In this group of patients, suicidal tendencies may occur, so the doctor should prescribe the smallest dose of the medicine to prevent intentional overdose. Previously existing depression may manifest during zolpidem treatment. Since insomnia can be a symptom of depression, in case of persistent insomnia, the doctor should re-examine the patient.
Other psychic reactions and "paradoxical":
The use of sedatives and hypnotics, such as zolpidem, may be accompanied by other psychic reactions and paradoxical reactions, such as anxiety, increased insomnia, excitement, irritability, aggression, delusions, outbursts of anger, nightmares, hallucinations, inadequate behavior, and other behavioral disorders.
In such cases, treatment should be discontinued. The occurrence of such reactions is more likely in older patients.
Somnambulism and similar behaviors:
Stilnox may cause sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or having sex, etc.) when the patient has not woken up completely. The next morning, the patient may not remember the activities performed during the night. If any of the above behaviors occur in the patient, treatment with Stilnox should be discontinued immediately, and the patient should consult their doctor, as such behaviors during sleep can pose a serious risk of injury to the patient or their environment.
Consuming alcohol or taking other medicines that cause drowsiness at the same time as Stilnox may increase the risk of such behaviors during sleep, as well as taking zolpidem in doses exceeding the maximum recommended dose.
Tolerance:
When taking sedatives and hypnotics containing zolpidem, including Stilnox, for more than a few weeks, the sedative effect may decrease.
Dependence:
Taking Stilnox may lead to drug abuse and/or the development of psychological or physical dependence.
If the patient has ever had mental disorders, abused or been dependent on alcohol, prohibited substances, or medicines, they should inform their doctor. The risk of dependence is higher when Stilnox is taken for more than 4 weeks and in patients with mental disorders and/or a history of alcohol, prohibited substances, or medicine abuse.
In cases where physical dependence has developed, sudden discontinuation of treatment will be accompanied by withdrawal symptoms. These may include headaches and muscle pain, increased anxiety and tension, restlessness, confusion, and irritability. In severe cases, symptoms such as derealization, depersonalization, increased hearing acuity, numbness and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures may occur.
Rebound insomnia (rebound insomnia):
After discontinuing sedative treatment, a transient syndrome may occur, in which the symptoms that led to the initiation of sedative treatment recur in an intensified form.
These symptoms may be accompanied by other reactions, such as mood changes, anxiety, and fear.
It is essential to inform the patient about the possibility of rebound insomnia and take appropriate measures to minimize the risk of anxiety and other symptoms if they occur during treatment discontinuation.
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In the case of short-acting sedatives and hypnotics, the withdrawal syndrome may occur between doses.
Severe injuries:
The medicine may cause drowsiness and impaired consciousness, leading to falls and, consequently, severe injuries.
Patients with a prolonged QT interval syndrome:
The potential consequences of taking zolpidem in patients with a congenital prolonged QT interval syndrome are unknown. As a precaution, the doctor should carefully weigh the benefits and risks of zolpidem treatment in patients with a diagnosed, congenital prolonged QT interval syndrome.

Children and adolescents

Stilnox should not be taken in children and adolescents under 18 years of age, as the safety and efficacy of zolpidem have not been established in this age group.

Stilnox and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Alcohol:
Concomitant use of alcohol is not recommended.
The sedative effect of zolpidem may be enhanced during concomitant alcohol consumption. This may affect the ability to drive and operate machinery.
Medicines with a central nervous system depressant effect:
When taking zolpidem with certain medicines, sedation and psychomotor disorders the next day, including impaired driving ability, may be enhanced. These medicines include:

• Medicines used to treat certain mental health disorders (antipsychotics)
• Medicines used to treat sleep disorders (sedatives)
• Sedatives or anxiolytics
• Medicines used to treat depression
• Medicines used to treat moderate to severe pain (opioid analgesics)
• Medicines used to treat epilepsy
• Medicines used for anesthesia
• Medicines used to treat hay fever, rash, or other allergies that may cause drowsiness in the patient (sedating antihistamines)

When taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not real (visual hallucinations).
Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.
Concomitant use of Stilnox and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and may be fatal. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
However, when the doctor prescribes Stilnox together with opioids, the dose and duration of concomitant use should be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and strictly follow the dosage instructions. It may be helpful to inform your friends and family to be aware of the above signs and symptoms.
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In case of these symptoms, consult your doctor.
Cytochrome P450 inhibitors and inducers:
Certain medicines that inhibit liver enzymes (especially cytochrome P450) may enhance the effect of certain sedatives, such as zolpidem.
Concomitant use of CYP3A4 inducers, such as rifampicin and St. John's Wort, reduces the pharmacodynamic effect of zolpidem.
Concomitant use of St. John's Wort may decrease zolpidem levels in the blood. Concomitant use of zolpidem with St. John's Wort is not recommended.
Concomitant administration of zolpidem with ketoconazole (200 mg twice daily) may enhance its sedative effect.
Other medicines:
No significant pharmacokinetic interactions have been observed when zolpidem is taken with warfarin, digoxin, and ranitidine.

Stilnox with food and drink

Take the medicine directly before going to bed or after lying down.

Pregnancy and breastfeeding

Pregnancy
Stilnox is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine.
Taking Stilnox during pregnancy may affect the baby. Some studies have shown an increased risk of cleft lip and palate (sometimes called "harelip") in newborns.
There may be decreased fetal movement and variable fetal heart rate if the mother takes Stilnox in the second and/or third trimester of pregnancy.
If the patient takes Stilnox in late pregnancy or during childbirth, the baby may experience muscle weakness, low body temperature, feeding difficulties, and breathing difficulties (respiratory depression).
If the patient regularly takes Stilnox in late pregnancy, the baby may develop physical dependence, and withdrawal symptoms may occur, such as excitement or seizures.
In such cases, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Do not take Stilnox during breastfeeding, as a small amount of the medicine passes into breast milk.

Driving and operating machinery

Stilnox has a major impact on the ability to drive and operate machinery and may cause events such as "falling asleep at the wheel". The next day after taking Stilnox (like other sedatives), it may happen that:

• The patient feels drowsy, sleepy, dizzy, or disoriented,
• The patient needs more time to make quick decisions (impaired reflexes),
• The patient may see double or blurred vision,
• The patient may be less alert.

To minimize the risk of the above events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, or working at heights.
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Do not consume alcohol or psychoactive substances while taking Stilnox, as this may enhance the above effects.

Stilnox contains lactose monohydrate

Stilnox contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Stilnox contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Stilnox

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Take the medicine orally.
Stilnox acts quickly, so take it directly before going to bed or after lying down.
Like all sedatives, long-term use of Stilnox is not recommended. The recommended treatment duration should not exceed 4 weeks.
In some cases, it may be necessary to extend the treatment period by the doctor beyond the maximum recommended duration, but this should not be done without re-evaluating the patient's clinical condition by the doctor.
Adults:
The recommended dose of Stilnox is 10 mg (1 tablet) per day (24 hours). Your doctor may prescribe a lower dose for some patients. Stilnox should be taken:

• in a single dose,
• directly before bedtime

The patient must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased concentration.
Do not exceed the dose of 10 mg per 24 hours.
Older patients:
In older or weakened patients who may be particularly sensitive to zolpidem, a dose of 5 mg of Stilnox (half a tablet) is recommended. In this group of patients, the daily dose should not exceed 10 mg.
Patient with liver function disorders:
In patients with liver function disorders, the doctor will reduce the initial dose to 5 mg, exercising particular caution, especially in older patients.
In adults (under 65 years), the doctor may increase the dose to 10 mg if the patient's condition is good and the medicine is well tolerated, but only if the medicine is ineffective at a lower dose.
Children and adolescents:
The safety and efficacy of zolpidem have not been established in children and adolescents under 18 years of age. Therefore, Stilnox should not be taken in this group of patients (see section 2).
If you feel that the effect of Stilnox is too strong or too weak, consult your doctor.

Overdose of Stilnox

In case of overdose, consult your doctor immediately.
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In cases of zolpidem overdose, either alone or in combination with other central nervous system depressants (including alcohol), impaired consciousness of varying severity has been observed, ranging from increased drowsiness to coma, as well as very severe symptoms, including death.
After zolpidem overdose, symptomatic and supportive treatment is recommended; gastric lavage or activated charcoal may be performed to reduce absorption of the medicine from the gastrointestinal tract.
Sedatives should be discontinued, even in case of excitement.
In case of severe symptoms, the doctor will consider administering flumazenil, but flumazenil administration may cause neurological symptoms (seizures).
Zolpidem is not eliminated from the body by hemodialysis.

Missed dose of Stilnox

Take the medicine the next day at the usual time. Do not take two doses of the medicine at the same time or at short intervals.

Discontinuation of Stilnox

Do not stop taking Stilnox abruptly, as this increases the risk of withdrawal symptoms. The doctor will inform the patient about how to stop treatment by gradually reducing the dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Stilnox can cause side effects, although not everybody gets them.
There is evidence that the side effects associated with taking the medicine, especially central nervous system side effects, depend on the dose of the medicine. Side effects are less severe if the medicine is taken directly before going to bed or after lying down (see section 3). They are most commonly observed in older patients.
The following side effects may occur:

• Common (may affect up to 1 in 10 people): drowsiness, headache, dizziness, increased insomnia, anterograde amnesia (amnesia may be associated with unusual behavior)
• hallucinations, excitement, nightmares, depression (see section 2)
• fatigue
• diarrhea, nausea, vomiting, abdominal pain
• upper and lower respiratory tract infections
• back pain

Uncommon (may affect up to 1 in 100 people):

• confusional state, irritability, restlessness, aggression, somnambulism (see section 2), euphoria
• double vision
• paresthesia (tingling, prickling), tremors
• attention disorders, speech disorders
• blurred vision
• increased liver enzyme activity
• rash, itching, excessive sweating
• eating disorders
• joint pain, muscle pain, muscle cramps, neck pain, muscle weakness
• Stilnox may cause sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or having sex, etc.) when the patient has not woken up completely (see section Warnings and precautions).

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

• libido disorders (sex drive)
• consciousness disorders
• liver damage caused by toxic effects of the medicine
• hives
• vision disorders
• gait disorders, falls (especially in older patients and when the medicine is not taken as recommended) - see section 2

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

• delusions, dependence (after stopping treatment, withdrawal symptoms or rebound effect may occur)
• respiratory depression (breathing difficulties) - see section 2

Frequency not known (cannot be estimated from the available data):

• anger, behavioral disorders Most psychic side effects are associated with paradoxical reactions.
• angioedema (severe allergic reaction - edema may involve the face, limbs, mouth, throat, and cause breathing difficulties)
• tolerance to the medicine
• delirium (sudden and severe change in mental state, which causes the person to appear disoriented or confused).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stilnox

There are no special precautions for storage.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Package contents and other information

What Stilnox contains

• The active substance of Stilnox is zolpidem. Each coated tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, hypromellose, sodium carboxymethylcellulose (type A), magnesium stearate. Coating: hypromellose, titanium dioxide (E 171), macrogol 400.

What Stilnox looks like and contents of the package

Stilnox is a coated tablet. The tablet can be divided into two halves.
The package contains 10, 14, 20, or 28 coated tablets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Sanofi Romania SRL
Gara Herăstrău Street, no. 4, Building B, floors 8-9
Sector 2, Bucharest
Romania

Manufacturer:

Sanofi Winthrop Industrie
30-36 Gustave Eiffel, 37100 Tours, France
Chinoin Private Co. Ltd.
Levai utca 5, 2112 Veresegyház, Hungary

Parallel importer:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus Street 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus Street 111
91-222 Łódź
Romanian marketing authorization number, country of export:
1344/2009/01
1344/2009/02
1344/2009/03
1344/2009/04

Parallel import authorization number: 632/15

Date of leaflet approval:18.08.2022
[Information about the trademark]
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