Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Stilnox
10 mg, film-coated tablets
Zolpidemi tartras
Please read the entire 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. This medicine may harm someone else, 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

What Stilnox is and what it is used for
What you need to know before taking Stilnox
How to take Stilnox
Possible side effects
How to store Stilnox
Contents of the pack and other information

1. What Stilnox is and what it is used for

Stilnox is available as film-coated tablets and contains the active substance: zolpidem tartrate.
Zolpidem belongs to a group of medicines known as hypnotics and sedatives.
The medicine helps you fall asleep, reduces the number of nocturnal 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 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 using Stilnox

Do not use Stilnox if:

you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6)
you have severe liver failure
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, etc.) 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, the underlying 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 the presence of primary psychiatric or physical disorders requiring diagnosis and ongoing medical evaluation.

Respiratory insufficiency:
Since sleeping medicines may depress respiratory function, caution is required 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 failure. Administration of Stilnox in patients with severe liver failure may lead to encephalopathy – a disorder of central nervous system function caused by liver failure (see section 2. "Important information before using 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 initial treatment of psychiatric disorders.

Next-day psychomotor impairments (see also "Driving and operating machinery"):
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 if:

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

A single dose should be taken immediately before going to bed.
Do not take another dose the same night.

Amnesia:
Sedative and hypnotic medicines may cause anterograde amnesia. This most commonly occurs several hours after taking the medicine. To reduce this risk, patients should ensure they can have an uninterrupted sleep of 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 is not known whether this is caused by the medicine or other factors. If you have suicidal thoughts, contact your doctor as soon as possible 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 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 group of patients; therefore, the doctor should prescribe the smallest effective dose to prevent intentional overdose. Depression previously present may emerge 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.

Sleepwalking and similar behaviours:
Stilnox may cause sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls or having sexual intercourse, etc.) while the patient is not fully awake. The patient may not remember these activities the next 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 tension, restlessness, confusion and irritability. In severe cases, symptoms such as derealisation, depersonalisation, increased auditory acuity, numbness and tingling of extremities, hypersensitivity to light, noise and touch, hallucinations and seizures may occur.

Rebound insomnia (insomnia rebound):
After stopping hypnotic treatment, a transient syndrome may occur in which the symptoms that led to 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.
With short-acting sedative and hypnotic medicines, withdrawal syndrome 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 long QT syndrome are unknown. As a precaution, your doctor should carefully consider the benefit-risk ratio of zolpidem treatment in patients diagnosed with congenital long QT 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 or have recently taken, as well as any you 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 with central nervous system depressant effects:
When zolpidem is taken together with certain medicines, drowsiness and next-day psychomotor impairments, including impaired driving ability, may be intensified. These include:

Medicines used to treat certain mental disorders (antipsychotics)
Medicines used to treat sleep problems (sleeping medicines)
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 anaesthesia
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, patients 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 depression), 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 strictly 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 about the signs and symptoms listed above.
If any of these symptoms occur, contact your doctor.

Inhibitors and inducers of cytochrome P450:
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, zolpidem blood levels may be reduced. 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 intensify its sedative effect.

Other medicines:
No significant pharmacokinetic interactions have been 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 lying down.

Pregnancy and breastfeeding

Pregnancy
Stilnox is not recommended during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, you should consult your doctor before using this medicine.
Use of this medicine during pregnancy 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 delivery, 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 during the postnatal period.

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

Driving and operating machinery
Stilnox has a major effect 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 sleeping medicines), you may:

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

To minimise the risk of such 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 listed above.

Stilnox contains lactose monohydrate
Stilnox contains lactose monohydrate. If you have been previously diagnosed with an 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 should not exceed 4 weeks.
In certain cases, the doctor may consider it necessary to extend the treatment period beyond the maximum recommended duration; 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 an interval of at least 8 hours between taking the medicine and engaging in activities requiring increased concentration.
The dose of 10 mg within 24 hours must not be exceeded.

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 recommended
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 – as well as very severe symptoms, including death.
After a 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 in quick succession.

Stopping Stilnox treatment
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 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 when 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, restlessness, aggression, somnambulism (see section 2.), euphoria
double vision
paraesthesia (tingling, pricking sensations), 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
the Stilnox medicine may cause sleepwalking or other unusual behaviours during sleep (such as driving a vehicle, eating food, making phone calls or engaging in sexual activity, etc.) 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 due to toxic effects of the medicine
urticaria
visual disturbances
gait disturbances, falls (especially in elderly patients and when the medicine has not been taken as recommended) – see section 2.

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

delusions, dependence (after discontinuation of treatment, 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 the person to appear confused or disoriented).

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

5. How to store Stilnox

No special storage conditions are required.
Keep the medicine out of the 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. These measures will help protect
the environment.

6. Contents of the pack and other information

What Stilnox contains

The active substance is zolpidem tartrate. Each coated tablet contains 10 mg of zolpidem tartrate.
Other ingredients: monohydrate lactose, 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
Oval, white coated tablets marked with the word "STILNOX" on one side and a division line on the other side. The tablet can be divided into equal doses.
The pack contains 10, 14, 20 or 28 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

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation numbers in Romania, country of export:
1344/2009/04
1344/2009/03
1344/2009/02
1344/2009/01

Parallel Import Authorisation number: 632/15