Stilnox

Leaflet attached to the packaging: information for the user

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

Stilnox

10 mg,coated tablets
Zolpidem tartrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 or pharmacist. 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. Contents of the pack 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 nocturnal awakenings, prolongs the duration of sleep, and improves its quality.
Stilnox is used for the short-term treatment of insomnia in patients over 18 years of age, when insomnia causes the patient disabling weakness or severe suffering.
Do not take continuously. 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 and/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.

Warnings and precautions

Before starting treatment with Stilnox, you should discuss it with your doctor or pharmacist.
In each case, you should determine, if possible, the causes of insomnia and, if possible, eliminate the factors that cause it, before the doctor recommends taking a sleeping medicine.
Persistence of 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
Due to the fact that sedative and hypnotic medicines can inhibit the activity of the respiratory center, 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").
Elderly or weakened patients
Elderly or weakened patients should take a lower dose of the medicine, see section 3.
Mental illnesses
Sedative and hypnotic medicines, such as Stilnox, are not recommended for the initial treatment of mental illnesses.
Psychomotor disorders the next day (see also "Driving and operating machinery")
Like other sedative and hypnotic medicines, 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 medicines that have a central nervous system depressant effect or other medicines that increase the concentration of zolpidem in the blood, while consuming alcohol or taking prohibited substances. A single dose should be taken directly before sleep. Do not take another dose on the same night.

Amnesia:
Sedative and hypnotic medicines 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 sedative and hypnotic medicines, including this medicine. However, it has not been established 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.
Although no clinically significant interactions have been found between zolpidem and selective serotonin reuptake inhibitors (see section: Stilnox and other medicines) and other sedative and hypnotic medicines, caution should be exercised when taking zolpidem as well as other sedative and hypnotic medicines 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 occurring depression may become apparent when taking zolpidem. Since insomnia can be a symptom of depression, in case of persistent insomnia, the doctor should re-examine the patient.
Other psychological reactions and "paradoxical":
The use of sedative and hypnotic medicines, such as zolpidem, may be accompanied by other psychological reactions and paradoxical reactions, such as: anxiety, increased insomnia, agitation, 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 elderly 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 doctor should be consulted, 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:
In the case of long-term use of sedative and hypnotic medicines containing zolpidem, including Stilnox, for more than a few weeks, a decrease in their sedative effect may occur.
Dependence:
Taking Stilnox may lead to abuse and/or 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 tell 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. Headaches and muscle pain, increased anxiety and tension, restlessness, confusion, and irritability may occur. 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 sleep medicine, a transient syndrome may occur, in which the symptoms that led to the initiation of sedative and hypnotic 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 possibility of anxiety and other symptoms if they occur during treatment discontinuation.
In the case of short-acting sedative and hypnotic medicines, the withdrawal syndrome may occur between doses.
Severe injuries:
The medicine may cause drowsiness and impaired consciousness, which can lead to falls and, consequently, severe injuries.
Patients with a prolonged QT interval:
The potential consequences of taking zolpidem in patients with a congenital prolonged QT interval are unknown. As a precaution, the doctor should carefully consider the benefit-risk ratio of zolpidem treatment in patients with a diagnosed, congenital prolonged QT interval.

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.
Zolpidem's sedative effect 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 (sedative and hypnotic medicines)
• Sedative or anxiolytic medicines
• 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, skin rash, or other allergies that may cause drowsiness in the patient (sedating antihistamines). When taking zolpidem with antidepressant medicines, 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 sedation, breathing difficulties (respiratory failure), coma, and can be fatal. Therefore, concomitant use of these medicines should only be considered when other treatment methods 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.
Tell your doctor about all opioid medicines you are taking and strictly follow the dosage instructions. It may be helpful to inform your friends and relatives to be aware of the above signs and symptoms.
If these symptoms occur, you should contact your doctor.
Cytochrome P450 inhibitors and inducers:
Certain medicines that inhibit liver enzymes (especially cytochrome P450) may enhance the effect of certain sedative and hypnotic medicines, such as zolpidem.
Concomitant use of CYP3A4 inducers, such as rifampicin and St. John's wort, reduces the pharmacodynamic effect of zolpidem.
When concomitantly used with St. John's wort, the concentration of zolpidem in the blood may decrease. Concomitant use of zolpidem with St. John's wort is not recommended.
Concomitant administration of zolpidem with ketoconazole (at a dose of 200 mg twice daily) may enhance its sedative effect.
Other medicines:
No significant pharmacokinetic interactions have been observed when zolpidem is concomitantly used with warfarin, digoxin, and ranitidine.

Stilnox with food and drink

The medicine should be taken 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, you should consult your doctor before taking this medicine.
The medicine used 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 labor, the baby may show muscle weakness, lowered 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 experience withdrawal symptoms, such as agitation or seizures. In such a case, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Stilnox should not be taken 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 sedative and hypnotic medicines), 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.

In order 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.
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, you should 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

This medicine should be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
The medicine should be taken orally.
Stilnox acts quickly, so it should be taken directly before going to bed or after lying down.
Like all sedative and hypnotic medicines, 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 sleep.

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.
Elderly or weakened patients:
In elderly 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.
Patients with liver function disorders:
In patients with liver function disorders, the doctor will reduce the initial dose to 5 mg, while exercising particular caution, especially in elderly patients.
In adults (under 65 years of age), 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 in 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, you should consult your doctor.

Taking a higher dose of Stilnox than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately consult your doctor.
In cases of zolpidem overdose, either alone or in combination with other central nervous system depressants (including alcohol), impaired consciousness of varying degrees has been observed, from increased drowsiness to coma, as well as very severe symptoms, including death.
After an overdose of zolpidem, symptomatic and supportive treatment is recommended; gastric lavage or activated charcoal may be performed to reduce the absorption of the medicine from the gastrointestinal tract.
Sedative medicines should be discontinued, even in the case of occurring agitation.
In the event of severe symptoms, the doctor will consider administering flumazenil, but the use of flumazenil may cause neurological symptoms (seizures). Zolpidem is not eliminated from the body by hemodialysis.

Missing a dose of Stilnox

You should 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.

Stopping treatment with Stilnox

Do not suddenly stop taking Stilnox, as this increases the risk of withdrawal symptoms.
The doctor will inform the patient about how to end the treatment by gradually reducing the dose.
If you have any further doubts about taking this medicine, you should 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-related 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 elderly 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, agitation, nightmares, depression (see section 2)
• fatigue
• diarrhea, nausea, vomiting, abdominal pain
• infections of the upper and lower respiratory tract
• 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
• appetite disorders
• joint pain, muscle pain, muscle spasms, 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 the toxic effect of the medicine
• hives
• vision disorders
• gait disorders, falls (especially in elderly 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 phenomenon may occur)
• respiratory depression (breathing difficulties) - see section 2
• Frequency not known (frequency cannot be estimated from the available data):
• anger, behavioral disorders. Most psychological side effects are associated with paradoxical reactions.
• angioedema (severe allergic reaction - edema may affect the face, limbs, mouth, and 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Stilnox

There are no special precautions for storage.
The medicine should be stored 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Stilnox contains

• The active substance of Stilnox is zolpidem (in the form of zolpidem tartrate). 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 pack

Stilnox is a white, oval, coated tablet with "STILNOX" written on one side and a middle line on the other side. The tablet can be divided into equal doses.
The pack contains 14 coated tablets.
For more detailed information, you should consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Sanofi Romania SRL, Str. Gara Herăstrău, nr. 4, Clădirea B, etajele 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:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Romania, the country of export:1344/2009/04

Parallel import authorization number: 285/22 Date of leaflet approval: 13.07.2022

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