STILNOX 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. STILNOX, 10 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Stilnox is and what it is used for
4. Before you take Stilnox
   1. Do not take Stilnox:
   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 using machines
   8. Stilnox contains lactose
   9. Stilnox contains sodium
5. How to take Stilnox
   1. Overdose of Stilnox
   2. Missed dose of Stilnox
   3. Discontinuation of Stilnox
6. Possible side effects
   1. Reporting of side effects
7. How to store Stilnox
8. Contents of the pack and other information
   1. What Stilnox contains
   2. What Stilnox looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

STILNOX, 10 mg, film-coated tablets

Zolpidem tartrate

Read all of this leaflet carefully before 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Stilnox is and what it is used for
• 2. Before you take 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 film-coated tablet containing the active substance zolpidem.
Zolpidem belongs to a group of medicines called sedative-hypnotics.
It helps you to fall asleep, reduces the number of times you wake up during the night, increases the duration of sleep and improves the quality of sleep.
Stilnox is used for the short-term treatment of insomnia in adults aged 18 years and above when insomnia is causing the patient significant distress or impairment of social and occupational functioning.
Do not take Stilnox for more than 4 weeks. Treatment should be as short as possible because the risk of dependence increases with the duration of treatment.

2. Before you take Stilnox

Do not take Stilnox:

• if you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver impairment
• if you have sleep apnea syndrome
• if you have severe respiratory impairment
• if you have myasthenia gravis
• if you have been prescribed this medicine for long-term treatment. Treatment should be as short as possible because the risk of dependence increases with the duration of treatment.
• if you have ever experienced sleepwalking or other unusual behaviors during sleep (such as driving, eating, talking on the phone, or having sex, etc.) when you have not been fully awake after taking Stilnox or another medicine containing zolpidem.

Warnings and precautions

Before taking Stilnox, discuss with your doctor or pharmacist.
In each case, try to identify and eliminate the underlying causes of insomnia before your doctor prescribes a hypnotic.
Persistence of insomnia after 7-14 days of treatment may indicate the presence of underlying psychological or physical disorders that require evaluation and treatment by your doctor at regular intervals.
Respiratory impairment:
Because sedative-hypnotics can suppress the activity of the respiratory center, caution should be exercised when administering Stilnox to patients with respiratory impairment (see section 4).
Liver impairment:
Liver impairment - see section 3: "How to take Stilnox":
Stilnox should not be used in patients with severe liver impairment. Use of Stilnox in patients with severe liver impairment may lead to encephalopathy - a disorder of brain function caused by liver impairment (see section 2: "Before you take Stilnox").
Elderly or debilitated patients:
Elderly or debilitated patients should use a lower dose, see section 3.
Psychiatric disorders:
Sedative-hypnotics, such as Stilnox, are not recommended for the primary treatment of psychiatric disorders.
Psychomotor retardation the next day (see also "Driving and using machines")
Like other sedative-hypnotics, zolpidem has a sedative effect on the central nervous system.
The next day after taking Stilnox, the risk of psychomotor impairment, 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 during treatment with other medicines that have a sedative effect on the central nervous system or other medicines that increase the concentration of zolpidem in the blood, while consuming alcohol or taking illicit substances

Take a single dose immediately before bedtime.
Do not take another dose during the same night.
Anterograde amnesia:
Sedative-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 of 8 hours.
Suicidal thoughts, suicide attempts, and depression:
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedative-hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or other factors. If the patient has suicidal thoughts, they should contact their doctor immediately for 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-hypnotics, caution should be exercised when using zolpidem as well as other sedative-hypnotics in patients with symptoms of depression.
In this patient group, suicidal tendencies may occur, so the doctor should prescribe the lowest dose of the medicine to prevent intentional overdose. Pre-existing depression may become apparent during treatment with zolpidem. Since insomnia can be a symptom of depression, if insomnia persists, the doctor should re-examine the patient.
Other psychiatric reactions and "paradoxical" reactions:
The use of sedative-hypnotics, such as zolpidem, can be associated with other psychiatric reactions and paradoxical reactions, such as anxiety, increased insomnia, agitation, aggression, delusions, rage, nightmares, hallucinations, inappropriate 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 can cause sleepwalking or other unusual behaviors during sleep (such as driving, eating, talking on the phone, or having sex, etc.) when the patient has not been fully awake. 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-hypnotics containing zolpidem, including Stilnox, for more than a few weeks, a decrease in their sedative effect may occur.
Dependence:
Taking Stilnox can lead to abuse and/or the development of psychological or physical dependence.
If the patient has ever had mental disorders, abused or been dependent on alcohol, illicit substances, or medicines, they should inform their doctor. The risk of dependence is higher when Stilnox is used for more than 4 weeks and in patients with a history of mental disorders and/or abuse of alcohol, illicit substances, or medicines.
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 depersonalization, derealization, increased sensitivity to sound, numbness and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures may occur.
Rebound insomnia (rebound insomnia):
After discontinuation of hypnotic treatment, a transient syndrome may occur, in which the symptoms that led to the initiation of hypnotic treatment recur in an intensified form. These symptoms may be accompanied by other reactions, such as mood changes, anxiety, and restlessness.
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.
In the case of short-acting sedative-hypnotics, withdrawal syndrome may occur between doses.
Severe injuries:
The medicine can cause drowsiness and impaired consciousness, which can lead to falls and, consequently, to severe injuries.
Patients with a prolonged QT interval:
The potential consequences of using zolpidem in patients with a congenital prolonged QT interval are unknown. As a precaution, the doctor should carefully weigh the benefits and risks of treating with zolpidem in patients with a diagnosed, congenital prolonged QT interval.

Children and adolescents

Stilnox should not be used 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 might take.
Alcohol:
Concomitant use of alcohol is not recommended.
The sedative effect of zolpidem may be enhanced during concomitant consumption of alcohol. This may affect the ability to drive and use machines.
Medicines with a sedative effect on the central nervous system:
When using zolpidem with certain medicines, sedation and psychomotor impairment the next day, including impaired driving ability, may be increased. These medicines include:

• Medicines used to treat certain mental health disorders (antipsychotics)
• Medicines used to treat sleep disorders (sedative-hypnotics)
• 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 in anesthesia
• Medicines used to treat hay fever, allergies, or other conditions that may cause drowsiness (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, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be fatal. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
However, if the doctor prescribes Stilnox with opioids, the dose and duration of concomitant use should be limited by the doctor.
The patient should inform the doctor about all opioid medicines they are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends and family members about the above signs and symptoms.
In case of their occurrence, the patient should contact their doctor.
Cytochrome P450 inhibitors and inducers:
Certain medicines that inhibit liver enzymes (especially cytochrome P450) may enhance the effect of certain sedative-hypnotics, such as zolpidem.
Concomitant use of CYP3A4 inducers, such as rifampicin and St. John's Wort, may decrease the pharmacodynamic effect of zolpidem.
Concomitant use of St. John's Wort may decrease the concentration of zolpidem 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 during concomitant use of zolpidem and warfarin, digoxin, and ranitidine.

Stilnox with food and drink

The medicine should be taken immediately before bedtime or after going to bed.

Pregnancy and breastfeeding

Pregnancy
Stilnox is not recommended during pregnancy. If the patient is pregnant, thinks she may be pregnant, or plans to have a baby, she should consult her doctor before taking this medicine.
The use of Stilnox during pregnancy may affect the baby. Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.
Decreased fetal movement and variable fetal heart rate may occur 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, her baby may show weakness, low body temperature, feeding difficulties, and breathing difficulties (respiratory depression).
If the patient takes Stilnox regularly in late pregnancy, her baby may develop physical dependence and experience withdrawal symptoms, such as agitation or convulsions. In such cases, the newborn should be closely monitored during the postnatal period.
Breastfeeding
Stilnox should not be used during breastfeeding, as a small amount of the medicine passes into breast milk.

Driving and using machines

Stilnox has a major influence on the ability to drive and use machines, and may cause events such as "falling asleep at the wheel". The next day after taking Stilnox (like other sedative-hypnotics), 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 an interval of at least 8 hours between taking zolpidem and driving, using machines, or working at heights.
Do not consume alcohol or psychoactive substances while taking Stilnox, as this may enhance the above effects.

Stilnox contains lactose

Stilnox contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Stilnox contains sodium

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

3. How to take Stilnox

Take this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
The medicine should be taken orally.
Stilnox acts quickly, so it should be taken immediately before bedtime or after going to bed.
Like all sedative-hypnotics, 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). Some patients may be prescribed a lower dose by their doctor. Stilnox should be taken:

• as a single dose
• immediately before bedtime

The patient must maintain an interval of at least 8 hours between taking the medicine and engaging in activities that require increased alertness.
Do not exceed the dose of 10 mg per 24 hours.
Elderly or debilitated patients:
In elderly or debilitated patients who may be particularly sensitive to zolpidem, a dose of 5 mg of Stilnox (half a tablet) is recommended. In this patient group, the daily dose should not exceed 10 mg.
Patients with liver impairment:
In patients with liver impairment, the doctor will reduce the initial dose to 5 mg, 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 in children and adolescents under 18 years of age have not been established. Therefore, Stilnox should not be used in this patient group (see section 2).
If you feel that the effect of Stilnox is too strong or too weak, consult your doctor.

Overdose of Stilnox

If you have taken more than the recommended dose of Stilnox, contact your doctor immediately.
In cases of overdose of zolpidem alone or concomitantly with other medicines that have a sedative effect on the central nervous system (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 administered to reduce the absorption of the medicine from the gastrointestinal tract.
Sedatives should be discontinued, even in the case of existing agitation.
In the event of severe symptoms, the doctor will consider the administration of flumazenil, but the use of flumazenil may cause neurological symptoms (seizures).
Zolpidem is not eliminated from the body by hemodialysis.

Missed dose of Stilnox

Take the next dose at the usual time. Do not take two doses at the same time or in a short interval.

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.
In case of any further doubts about the use of 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 side effects associated with the use of 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 immediately before bedtime or after going to bed (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 enzymes
• 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, talking on the phone, or having sex, etc.) when the patient has not been fully awake (see section 2: "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 effect may occur)
• respiratory depression (breathing difficulties) - see section 2

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

• anger, behavioral disorders Most psychiatric side effects are associated with paradoxical reactions
• angioedema (severe allergic reaction - edema may involve the face, limbs, oral cavity, 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 of side effects

If you experience any side effects, including those 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, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
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 storage requirements.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Stilnox contains

• The active substance is zolpidem. Each film-coated tablet contains 10 mg of zolpidem (as zolpidem tartrate).
• The other ingredients are: lactose, microcrystalline cellulose, hypromellose, sodium carboxymethylcellulose, magnesium stearate. The coating contains: hypromellose, titanium dioxide, macrogol 400.

What Stilnox looks like and contents of the pack

Stilnox is a film-coated tablet. The tablet can be divided into two halves.
The pack contains 7, 14, or 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France
Manufacturer:
Sanofi-Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warszawa
Phone: +48 22 280 00 00

Date of last revision of the leaflet: