Stilnox

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Stilnox (Stilnoct)
10 mg, coated tablets
Zolpidem tartrate
Stilnox and Stilnoct are different trade names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, 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 identical.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 initiate sleep, reduces the number of nocturnal awakenings, prolongs sleep duration, and improves sleep quality.
Stilnox is used for the 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 long-term. 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 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, because 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), without fully waking up after taking Stilnox or another medicine containing zolpidem.

Warnings and precautions
Before starting Stilnox, discuss this with your doctor or pharmacist.
In all cases, the underlying causes of insomnia should be identified, if possible, and contributing factors eliminated as far as possible before your doctor prescribes a hypnotic medicine.
Persistent insomnia after 7–14 days of treatment may indicate the presence of primary psychiatric or physical disorders requiring diagnosis and evaluation by your doctor at regular intervals.

Respiratory insufficiency:
Since hypnotic medicines may depress respiratory centre function, caution should be exercised when using Stilnox in patients with respiratory disorders (see section 4).

Liver function disorders:
Liver function disorders – see section 3. "How to use 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 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:
Hypnotic 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 hypnotic medicines, zolpidem exerts a depressant effect on the central nervous system. 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 medicines that depress the central nervous system or that increase zolpidem blood levels, or with alcohol or illicit substances.

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

Amnesia:
Sedative and hypnotic medicines may cause anterograde amnesia. This most commonly occurs several hours after taking the medicine. To reduce the risk, patients should ensure they are able to 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 has not been established whether this is due to the medicine or whether there are other causes. If a patient experiences suicidal thoughts, they should contact their 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 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 doctor should re-evaluate the patient if insomnia persists.

Other psychiatric reactions and "paradoxical" reactions:
Treatment with sedative and hypnotic medicines such as zolpidem may be associated with other psychiatric and paradoxical reactions such as: anxiety, increased 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), when the patient has not fully woken up. 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.
Consuming alcohol or taking other sedating 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, a reduction in their hypnotic effect may occur.

Dependence:
Use of Stilnox may lead to drug abuse and/or development of psychological or physical dependence.
If the patient has ever had psychiatric disorders, or has 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 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 convulsions 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 take appropriate measures to minimise the risk of anxiety and other symptoms if they occur during withdrawal.
With 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 prolonged QT interval syndrome:
The potential consequences of using zolpidem in patients with congenital long QT syndrome are unknown. As a precautionary measure, the doctor should carefully weigh the benefits against the risks of treating patients diagnosed with congenital long QT syndrome with zolpidem.

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 any medicines you are currently taking, have recently taken or might take.
Alcohol:
Concomitant use of alcohol is not recommended.
The sedative effect of zolpidem may be enhanced when alcohol is consumed at the same time. This may affect the 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 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
• 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, 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 so they are aware of the above 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 enhance the effect 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 is 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, think 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 "harelip") in newborns.
Reduced foetal movement and variable foetal heart rate may occur if Stilnox is used during the second and/or third trimester of pregnancy.
If you use Stilnox during late 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 during late 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
Stilnox must not be used during breastfeeding, as a small amount of the medicine passes into human milk.

Driving and operating machinery
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 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 have blurred or double vision
• the patient may be less alert.

To minimise the risk of these events, it is recommended to maintain a minimum interval of 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 an intolerance to certain sugars, you should consult your doctor before taking this medicine.

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

3. How to use Stilnox

This medicine should be taken as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The medicine should be taken orally.
Stilnox acts rapidly and therefore 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 treatment period may need to be extended beyond the maximum recommended duration by the physician; however, this must not occur 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). Some patients may be prescribed a lower dose by the doctor. 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 within 24 hours.

Elderly patients:
In elderly patients or weakened 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 have not been established in children and adolescents under 18 years of age. 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 recommended, 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 – ranging from excessive drowsiness to coma – and very severe symptoms, including death.
In case of 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 provoke neurological symptoms (seizures).
Zolpidem is not eliminated from the body by hemodialysis.

Missing a dose of Stilnox
Take the medicine the next day at the usual time. Do not take two doses at once or within a short time interval.

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 medicinal product may 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 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 (memory loss 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
• diplopia (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
• the Stilnox medicine may cause sleepwalking or other unusual sleep-related behaviours (such as driving, eating, 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 hepatotoxic liver damage
• urticaria
• visual disturbances
• gait disturbances, fall (particularly 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 of treatment, 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 involve the face, limbs, oral cavity, larynx, and may cause breathing difficulties)
• tolerance to the medicine
• 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 the medicine.

5. How to store Stilnox

No special storage instructions 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 sewage or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. This 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.

• The other ingredients are: monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (type A), magnesium stearate. Film-coat composition: hypromellose, titanium dioxide (E 171), macrogol 400.

What Stilnox looks like and contents of the pack
Stilnox is a white, elongated coated tablet with a division line and engraved with "SN10". The tablet can be divided into two equal parts.
The pack contains 14 coated tablets.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Ireland, country of export:
Sanofi-aventis Ireland Limited T/A SANOFI
Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Delpharm Dijon
6, Boulevard de l’Europe
21800 Quétigny, France
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Ireland, country of export: PA 540/160/2
Parallel Import Licence Number: 28/22