Stilnox

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
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 with falling 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 when insomnia causes significant impairment or distress 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 impairment
• you have sleep apnoea syndrome
• you have acute and/or severe respiratory insufficiency
• you have myasthenia gravis
• you are undergoing 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 sleep-related behaviours (such as driving, eating, making phone calls or engaging in sexual activity, etc.) while not fully awake after taking Stilnox or another medicine containing zolpidem.

Warnings and precautions
Talk to your doctor or pharmacist before taking Stilnox.
In all cases, the underlying causes of insomnia should be identified, if possible, and contributing factors eliminated before your doctor prescribes a sleeping medicine.
Persistent insomnia after 7–14 days of treatment may indicate the presence of underlying psychiatric or physical disorders requiring diagnosis and regular medical evaluation.

Respiratory insufficiency:
Since sleeping medicines may depress respiratory centre function, caution is advised when using Stilnox in 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 impairment. Administration of Stilnox in patients with severe liver impairment may lead to encephalopathy – a disturbance 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, see section 3.

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

Next-day psychomotor impairments (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 impaired ability to drive, may be increased if:

• the medicine is taken less than 8 hours before activities requiring full alertness,
• a higher than recommended dose is taken,
• zolpidem is taken together with other centrally acting depressant medicines or other drugs that increase zolpidem blood levels, while consuming alcohol, or while using 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 one. However, it is not known whether this is caused by the medicine or other factors. If you experience suicidal thoughts, contact your doctor immediately for medical advice.
Although no clinically significant interactions between zolpidem and selective serotonin reuptake inhibitors (see section: "Stilnox with other medicines") or other sedative and hypnotic medicines have been established, 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 smallest effective dose to prevent intentional overdose. Pre-existing depression may become apparent during treatment with zolpidem. Since insomnia may be a symptom of depression, the patient should be re-evaluated 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, anger outbursts, nightmares, illusions, inappropriate behaviour and other behavioural disturbances.
In such cases, treatment should be discontinued. These reactions are more likely to occur in elderly patients.

Sleepwalking and similar behaviours:
Stilnox may cause sleepwalking or other unusual sleep-related behaviours (such as driving, eating, making phone calls or engaging in sexual activity, etc.) while the patient is not fully awake. The patient may not remember these activities the next morning. If any of these behaviours occur, Stilnox treatment must 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.
Consuming alcohol or taking other sedative medicines 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 higher 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 tension, restlessness, confusion and irritability. In severe cases, symptoms such as derealisation, depersonalisation, increased auditory sensitivity, numbness and tingling of limbs, hypersensitivity to light, noise and touch, illusions 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 sedative and hypnotic treatment return in an intensified form.
These symptoms 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 apply appropriate measures to minimise the risk of anxiety and other symptoms if they occur during discontinuation.
When short-acting sedative and hypnotic medicines are used, 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 prolonged QT interval syndrome:
The potential consequences of using zolpidem in patients with congenital prolonged QT interval syndrome are unknown. As a precaution, your doctor should carefully consider the benefit-risk ratio of zolpidem treatment in patients diagnosed with congenital prolonged QT interval 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 with 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 when alcohol is consumed simultaneously. This may affect your ability to drive and operate machinery.

Medicines with central nervous system depressant effects:
When zolpidem is used together with certain medicines, drowsiness and next-day psychomotor impairments, including impaired driving ability, may be intensified. These medicines include:

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

When zolpidem is taken together with antidepressants such as bupropion, desipramine, fluoxetine, sertraline and venlafaxine, the patient may see unreal things (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 depression), coma and may be fatal. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
However, when 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 members to make them aware of the above-mentioned signs and symptoms.
If these symptoms occur, contact your doctor.

Cytochrome P450 inhibitors and inducers:
Some medicines that inhibit liver enzymes (especially cytochrome P450) may intensify the effects of certain hypnotics such as zolpidem.
Concomitant use of CYP3A4 inducers such as rifampicin and St John’s wort (Hypericum perforatum) reduces the pharmacodynamic effect of zolpidem.
When St John’s wort is used concomitantly, it 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 intensify its sedative effect.

Other medicines:
No significant pharmacokinetic interactions were observed when zolpidem was used concomitantly with warfarin, digoxin and ranitidine.

Stilnox with food and drink
Take the medicine immediately before going to bed or after going to bed.

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 using this medicine.
The medicine may affect the unborn child when used during pregnancy. Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.
Reduced foetal movement and variable foetal heart rate may occur if the mother uses Stilnox during the second and/or third trimester of pregnancy.
If you use 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 use Stilnox late in pregnancy, your baby may develop physical dependence and withdrawal symptoms such as agitation or seizures. In such cases, the newborn should be closely monitored in the postnatal period.

Breastfeeding
Do not use Stilnox during breastfeeding, as small amounts of the medicine pass into human milk.

Driving and using machines
Stilnox has a major influence on the ability to drive and operate machinery and may cause events such as "falling asleep at the wheel". The day after taking Stilnox (as with other hypnotics), 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 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 intensify the effects mentioned above.

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

Stilnox contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning 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 hypnotic medicines, prolonged use of Stilnox is not recommended. The recommended duration of treatment should not exceed 4 weeks.
In certain cases, the treatment period may need to be extended beyond the maximum recommended duration by the doctor; however, this must not occur without a re-evaluation 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 a period of at least 8 hours between taking the medicine and engaging in activities requiring increased concentration.
Do not exceed the dose of 10 mg within 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. For this reason, Stilnox should not be used in this patient group (see section 2).

If you feel the effect of Stilnox is too strong or too weak, consult your doctor.

Taking more Stilnox than prescribed
If you take more than the prescribed dose, seek medical advice immediately.
In cases of overdose with zolpidem alone or in combination with other centrally acting nervous system depressants (including alcohol), disturbances of consciousness of varying severity have been observed – 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 administration of activated charcoal may be performed 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 provoke neurological symptoms (seizures).
Zolpidem is not eliminated from the body by hemodialysis.

Missed dose of Stilnox
Take the next dose at the usual time the following day. Do not take a double dose or two doses close together.

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 gradually by tapering 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 everybody 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 affect 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 affect up to 1 in 100 people):

• confusion, irritability, anxiety, aggression, somnambulism (see section 2), euphoria
• double vision
• paraesthesia (tingling, pricking sensations), tremor
• attention disorders, 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 having sexual intercourse) when the patient has not fully awakened (see section "Warnings and precautions")

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

• libido disorders (sexual drive)
• disturbances of consciousness
• drug-induced liver injury
• urticaria
• visual disturbances
• gait disturbances, 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 discontinuation, withdrawal symptoms or "rebound" phenomena may occur)
• respiratory depression (difficulty breathing) – see section 2

Frequency not known (frequency cannot be estimated from the 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 difficulty in breathing)
• drug tolerance
• delirium (sudden and severe change in mental state causing the person to appear confused or disoriented)

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

5. How to store Stilnox

No special storage instructions are required.
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 stated month.
Medicines must 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.

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 tartrate.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (type A), magnesium stearate. Film-coat composition: 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 equal parts.
The pack contains 14 film-coated tablets.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing Authorisation Number in Romania, the country of export: 1344/2009/04
Parallel Import Licence Number: 246/23