Stilnox

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Stilnox
10 mg, coated tablets
Zolpidem tartrate
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Stilnox is and what it is 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 Stilnox is and what it is used for

Stilnox is available as coated tablets and contains the active substance zolpidem.
Zolpidem belongs to a group of medicines known as hypnotics and sedatives.
The medicine helps you fall asleep, reduces the number of night-time awakenings, prolongs sleep duration, and improves sleep quality.
Stilnox is indicated for short-term treatment of insomnia in patients over 18 years of age, in cases where insomnia causes the patient significant distress or impairment in daily functioning.
Do not use for prolonged periods. Treatment should be as short as possible, since 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 insufficiency
• you have sleep apnoea syndrome
• you have acute and/or severe respiratory insufficiency
• you have myasthenia gravis
• you require long-term treatment. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment
• you have ever experienced sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls or having sexual intercourse) while not fully awake after taking Stilnox or another medicine containing zolpidem.

Warnings and precautions
Before taking Stilnox, discuss this with your doctor or pharmacist.

In all cases, possible causes of insomnia should be identified and, if possible, eliminated before a doctor prescribes a sleeping medicine.
Persistent insomnia after 7–14 days of treatment may indicate underlying psychological or physical disorders requiring diagnosis and evaluation by a doctor at regular intervals.

Respiratory insufficiency
Since sleeping medicines may depress respiratory centre function, caution should be exercised when administering Stilnox to patients with respiratory disorders (see section 4).

Liver function disorders
Liver function disorders – see section 3. "How to take Stilnox".
Stilnox must not be used in patients with severe liver insufficiency. Administration of Stilnox in patients with severe liver insufficiency may lead to encephalopathy – a disorder of central nervous system function caused by liver failure (see section 2. "Important information before taking Stilnox").

Elderly or debilitated patients
Elderly or debilitated patients should use a lower dose of the medicine; see section 3.

Psychiatric disorders
Sleeping medicines such as Stilnox are not recommended for initial treatment of psychiatric disorders.

Next-day psychomotor impairment (see also “Driving and using machines”)
Like other sleeping medicines, zolpidem has a central nervous system depressant effect. The risk of next-day psychomotor impairment, including reduced ability to drive, may be increased the day after taking Stilnox if:

• the medicine is taken less than 8 hours before activities requiring full alertness
• a higher than recommended dose is taken
• zolpidem is taken concomitantly with other medicines that depress the central nervous system or other medicines that increase zolpidem blood levels, or with alcohol or illicit substances.

A single dose should be taken immediately before bedtime. Do not take another dose during the same night.

Amnesia:
Sedative and hypnotic medicines may cause anterograde amnesia. This usually occurs several hours after taking the medicine. To reduce the risk, the patient should ensure an uninterrupted 8-hour sleep period.

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 is not known whether this is caused by the medicine or whether other factors are involved. If you have suicidal thoughts, contact your doctor as soon as possible for medical advice.

Although clinically significant interactions between zolpidem and selective serotonin reuptake inhibitors (see section: Stilnox and other medicines) and other sedative and hypnotic medicines have not been observed, caution should be exercised when using zolpidem or other sedative and hypnotic medicines in patients with symptoms of depression.
Suicidal tendencies may occur in this patient group; therefore, the doctor should prescribe the lowest effective dose to prevent intentional overdose. Pre-existing depression may become apparent during zolpidem treatment. Since insomnia may be a symptom of depression, the doctor should re-evaluate the patient if insomnia persists.

Other psychiatric reactions and “paradoxical” reactions:
Sedative and hypnotic medicines such as zolpidem may be associated with other psychiatric and paradoxical reactions such as: anxiety, worsened insomnia, agitation, irritability, aggression, hallucinations, rage attacks, nightmares, illusions, inappropriate behaviour and other behavioural disturbances.
In such cases, treatment should be discontinued. The occurrence of such reactions is more likely in elderly patients.

Somnambulism and similar behaviours:
Stilnox may cause sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls or having sexual intercourse) while the patient is not fully awake. The patient may not remember these activities the following morning. If any of these behaviours occur, treatment with Stilnox should be stopped immediately and the patient should contact their doctor, as such sleep-related behaviours may pose a serious risk of injury to the patient or others.

Consumption of alcohol or taking other medicines causing drowsiness together with Stilnox may increase the risk of such sleep-related behaviours, as may using zolpidem at doses exceeding the maximum recommended dose.

Tolerance:
When sedative and hypnotic medicines containing zolpidem, including Stilnox, are used for longer than a few weeks, their hypnotic effect may decrease.

Dependence:
Use of Stilnox may lead to drug abuse and/or development of psychological or physical dependence.
If you have ever had psychiatric disorders, or abused or been dependent on alcohol, illicit substances or medicines, you should inform your doctor. The risk of dependence is greater when Stilnox is used for longer than 4 weeks and in patients with psychiatric disorders and/or a history of alcohol, illicit substance or medicine abuse.

In cases where physical dependence has developed, abrupt discontinuation of treatment may lead to withdrawal symptoms. These may include headache and muscle pain, increased anxiety and mental tension, restlessness, confusion and irritability. In severe cases, symptoms such as derealisation, depersonalisation, increased auditory sensitivity, numbness and tingling in the extremities, hypersensitivity to light, noise and touch, hallucinations and seizures may occur.

Rebound insomnia (rebound insomnia):
After stopping hypnotic treatment, a transient syndrome may occur in which the symptoms that led to the initiation of sedative and hypnotic treatment return in an intensified form. These may be accompanied by other reactions such as mood changes, restlessness and anxiety.
It is important to inform the patient about the possibility of rebound insomnia and to take appropriate measures to minimise the risk of anxiety and other symptoms if they occur during discontinuation of the medicine.
In the case of short-acting sedative and hypnotic medicines, withdrawal symptoms may occur between doses.

Serious injuries:
The medicine may cause drowsiness and impaired consciousness, which may lead to falls and consequently to serious injuries.

Patients with QT prolongation syndrome:
The potential consequences of using zolpidem in patients with congenital QT prolongation syndrome are unknown. As a precaution, the doctor should carefully consider the benefit-risk ratio of zolpidem treatment in patients diagnosed with congenital QT prolongation syndrome.

Children and adolescents
Stilnox must 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 currently taking, have recently taken or plan to take.

Alcohol:
Concomitant use of alcohol is not recommended.
The sedative effect of zolpidem may be intensified by alcohol consumption.
This may affect your ability to drive and operate machinery.

Medicines acting on the central nervous system:
When zolpidem is used with certain medicines, drowsiness and next-day psychomotor impairment, including impaired driving ability, may be intensified. These medicines include:

• Medicines used to treat certain mental disorders (antipsychotics)
• Medicines used to treat sleep problems (hypnotics)
• Sedatives or medicines reducing anxiety
• Medicines used to treat depression
• Medicines used to treat moderate to severe pain (opioid analgesics)
• Medicines used to treat epilepsy
• Medicines used in anaesthesia
• Medicines used to treat hay fever, rashes or other allergies, which may cause drowsiness (sedating antihistamines).

When zolpidem is taken with antidepressants such as 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, medicines used in substitution therapy and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory insufficiency), coma and may be fatal. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
However, if your 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 dosing instructions. It may be helpful to inform your friends and family so they are aware of the above signs and symptoms.
Contact your doctor if any of these symptoms occur.

Cytochrome P450 inhibitors and inducers:
Some medicines that inhibit liver enzymes (especially cytochrome P450) may enhance the effects of certain hypnotic medicines such as zolpidem.
Concomitant use of CYP3A4 inducers such as rifampicin and St John’s wort (Hypericum perforatum) reduces the pharmacodynamic effect of zolpidem.
Concomitant use of St John’s wort may reduce zolpidem blood levels. 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 was used concomitantly with warfarin, digoxin or ranitidine.

Stilnox with food and drink
The medicine should be taken immediately before going to bed or after lying down.

Pregnancy and breastfeeding
Pregnancy
Stilnox is not recommended during pregnancy. If you are pregnant, suspect you may be pregnant or are planning to become pregnant, you should consult your doctor before taking this medicine.
The medicine may affect the unborn child. Some studies have shown an increased risk of cleft lip and palate (sometimes called "harelip") in newborns.
Reduced foetal movement and variable foetal heart rate may occur if the mother takes Stilnox during the second and/or third trimester of pregnancy.
If you take Stilnox late in pregnancy or during labour, your baby may have muscle weakness, low body temperature, feeding difficulties and breathing problems (respiratory depression).
If you regularly take Stilnox late in pregnancy, your baby may develop physical dependence and withdrawal symptoms such as agitation or seizures may occur. In such cases, the newborn should be closely monitored in the postnatal period.

Breastfeeding
Stilnox must 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 while driving". The day after taking Stilnox (as with other hypnotic medicines), it may happen that:

• you feel drowsy, sleepy, dizzy or disoriented
• you need more time to make quick decisions (impaired reflexes)
• you may have blurred or double vision
• you may be less alert.

To minimise the risk of these events, it is recommended to allow at least 8 hours between taking zolpidem and driving, operating machinery or working at heights.
Do not consume alcohol or psychoactive substances while taking Stilnox, as this may intensify the effects mentioned above.

Stilnox contains lactose monohydrate
Stilnox contains lactose monohydrate. If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

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

3. How to use Stilnox

This medicine should be taken as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
The medicine should be taken orally.
Stilnox acts rapidly; therefore, it should be taken immediately before going to
bed or after lying down.
As with all sleep medicines, prolonged use of Stilnox is not recommended.
The recommended duration of treatment with this medicine should not exceed 4 weeks.
In some cases, the doctor may need to extend the treatment period beyond
the maximum recommended time; however, this must not be done without a renewed assessment of the patient's clinical condition by the doctor.

Adults
The recommended dose of Stilnox is 10 mg (1 tablet) per day (24 hours). The doctor may prescribe a lower dose for some patients. Stilnox should be taken:

• as a single dose,
• immediately before sleep.

The patient must ensure an interval of at least 8 hours between taking the medicine and engaging in activities requiring increased concentration.
Do not exceed the dose of 10 mg in 24 hours.

Elderly 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 hepatic impairment:
In patients with impaired liver function, 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 lower dose proves ineffective.

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.

Taking more Stilnox than prescribed
If you take more Stilnox than prescribed, contact your doctor immediately.
In cases of overdose with zolpidem alone or in combination with other central nervous system depressants (including alcohol), disturbances of consciousness of varying severity have been observed – from increased drowsiness to coma – and very severe symptoms, including death.
After a zolpidem overdose, symptomatic and supportive treatment is recommended; gastric lavage or activated charcoal may be administered to reduce drug absorption from the gastrointestinal tract.
Sedatives should be discontinued, even if agitation occurs.
In cases of severe symptoms, the doctor may consider administering flumazenil; however, the use of flumazenil 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 at once or in quick succession.

Stopping Stilnox
Do not stop taking Stilnox abruptly, as this increases the risk of withdrawal symptoms.
Your doctor will advise you on how to discontinue treatment by gradually reducing the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
There is evidence that adverse reactions associated with the use of this medicine, particularly adverse effects on the central nervous system, are dose-dependent. Adverse reactions are less pronounced if the medicine is taken immediately before going to bed or after lying down (see section 3). They are most commonly observed in elderly patients.
The following adverse reactions may occur:

Common (may occur in up to 1 in 10 people):

• drowsiness, headache, dizziness, worsening of insomnia, anterograde amnesia (amnesia may be associated with unusual behaviour)
• hallucinations, agitation, nightmares, depression (see section 2)
• fatigue
• diarrhoea, nausea, vomiting, abdominal pain
• upper and lower respiratory tract infections
• back pain

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

• confusion, irritability, restlessness, aggression, somnambulism (see section 2), euphoria
• double vision
• paraesthesia (tingling, pricking)
• tremor
• attention disturbances, speech disorders
• blurred vision
• increased liver enzyme activity
• rash, itching, excessive sweating
• appetite disturbances
• joint pain, muscle pain, muscle cramps, neck pain, muscle weakness
• Stilnox may cause sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or engaging in sexual activity) while the patient is not fully awake (see section: Warnings and precautions).

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

• libido disorders
• disturbances of consciousness
• drug-induced liver injury due to toxic effects of the medicine
• urticaria
• visual disturbances
• gait disturbances, falls (especially in elderly patients and when the medicine is not taken as directed) – see section 2.

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

• delusions, dependence (after discontinuation, withdrawal symptoms or rebound phenomena may occur)
• respiratory depression (difficulty breathing) – see section 2.

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

• anger, behavioural disturbances. Most psychiatric adverse reactions are related to paradoxical reactions.
• angioedema (a severe allergic reaction – swelling may affect the face, limbs, oral cavity, larynx, and may cause breathing difficulties)
• drug tolerance
• delirium (sudden and severe change in mental state causing disorientation or confusion).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Stilnox

No special storage instructions are required.
Keep this 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Stilnox contains

• The active substance is zolpidem (in the form of zolpidem tartrate). Each film-coated tablet contains 10 mg of zolpidem tartrate.
• Other ingredients are: lactose monohydrate, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (type A), magnesium stearate.
  Coating ingredients: hypromellose, titanium dioxide (E 171), macrogol 400.

What Stilnox looks like and contents of the pack
Stilnox is a white, oval film-coated tablet marked with "STILNOX" on one side and a central break line on the other. The tablet can be divided into equal doses. The pack contains 14 film-coated tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Sanofi Romania SRL, Str. Gara Herăstrău, no. 4, Clădirea 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:
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
Marketing authorisation number in Romania, country of export: 1344/2009/04
Parallel import authorisation number: 285/22