Stilnox

Package leaflet: Information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 film-coated tablets and contains the active substance zolpidem.
Zolpidem belongs to a group of medicines known as hypnotics and sedatives.
The medicine helps to initiate sleep, 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 of 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 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 behaviours during sleep (such as driving, eating, making phone calls or having sexual intercourse) after taking Stilnox or another medicine containing zolpidem, without fully waking up.

Warnings and precautions
Before starting to use Stilnox, discuss this with your doctor or pharmacist.
Whenever possible, the underlying causes of insomnia should be identified and, if possible, eliminated before your doctor prescribes a sleeping medicine.
If insomnia persists after 7–14 days of treatment, this may indicate the presence of underlying psychiatric or physical disorders, which require diagnosis and evaluation by a doctor at regular intervals.

Respiratory insufficiency:
Since sleeping medicines may depress respiratory 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 failure. The use 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 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 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 impaired 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 together with other medicines that depress the central nervous system, or with other medicines that increase blood levels of zolpidem, while consuming alcohol or while using 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 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 taking the medicine or whether other factors are involved. 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 and 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 group of patients; 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, your doctor should re-evaluate you if insomnia persists.

Other psychiatric reactions and "paradoxical" reactions:
The use of 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 episodes, 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) when the patient has not fully woken up. The patient may not remember these activities the next morning. If any of these behaviours occur, treatment with Stilnox should be stopped immediately and you should contact your doctor, as such sleep-related behaviours may pose a serious risk of injury to the patient or others.
Consuming alcohol or taking other medicines that cause 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:
The use of Stilnox may lead to drug abuse and/or the development of psychological or physical dependence.
If you have ever had psychiatric disorders, or have 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 (insomnia rebound):
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 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 discontinuation.
When short-acting sedative and hypnotic medicines are used, withdrawal symptoms may occur between doses.

Severe injuries:
The medicine may cause drowsiness and impaired consciousness, which may lead to falls and consequently to severe 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 precautionary measure, 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 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 when alcohol is consumed at the same time. 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 (sleeping pills)
• 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, the patient may see things that are not real (visual hallucinations).
The concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.
The 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. Because of this, 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 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 to be aware of the above-mentioned signs and symptoms.
If any of 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 sleeping medicines such as zolpidem.
Concomitant use of CYP3A4 inducers such as rifampicin and St John’s wort may reduce the pharmacodynamic effect of zolpidem.
When St John’s wort is used concomitantly, it may reduce the blood concentration of zolpidem. The 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 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, think you may be pregnant or are planning to become pregnant, you should consult your doctor before using this medicine.
The 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 uses Stilnox during the second and/or third trimester of pregnancy.
If you use Stilnox in late pregnancy or during delivery, 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 may occur.
In such cases, the newborn should be closely monitored during 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 sleeping 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 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 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
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Stilnox

This medicine should be taken exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine is for oral use only.
Stilnox works 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, your doctor may extend the treatment period beyond the maximum recommended duration; however, this must not be done without a re-evaluation of the patient's clinical condition by the doctor.

Adults
The recommended dose of Stilnox is 10 mg (1 tablet) once daily (every 24 hours). Your 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 performing any activities requiring increased concentration.
Do not exceed the dose of 10 mg within 24 hours.

Elderly patients
For 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 is 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 zolpidem overdose, either 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 – 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 trigger neurological symptoms (seizures).
Zolpidem is not eliminated from the body by hemodialysis.

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

Stopping Stilnox treatment
Do not stop taking Stilnox suddenly, as this increases the risk of withdrawal symptoms. Your doctor will advise you on how to discontinue treatment gradually by reducing the dose step by step.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
There is evidence that adverse reactions associated with the use of the medicine, especially 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 (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
• double vision
• paraesthesia (tingling, pricking sensations), tremor
• disturbances in attention, 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, eating, making phone calls, or engaging in sexual activity, etc.) when the patient is not fully awake (see section Warnings and precautions)

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

• libido disorders (sexual drive)
• disturbances in 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 recommended) – see section 2

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

• delusions, dependence (withdrawal symptoms or a "rebound" phenomenon may occur after discontinuation of treatment)
• 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 (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, tell your doctor, pharmacist, or nurse. Adverse reactions can also 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 provide more information on the safety of the 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. Such practices help protect the environment.

6. Contents of the pack and other information

What Stilnox contains

• The active substance is zolpidem. Each coated tablet contains 10 mg of zolpidem (as zolpidem tartrate).
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (type A), magnesium stearate. Film-coat ingredients: hypromellose, titanium dioxide (E 171), polyethylene glycol 400.

What Stilnox looks like and contents of the pack
Stilnox is a coated tablet. The tablet can be divided into halves.
Pack contains 14 or 28 coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Irish licence number, country of export: PA 540/160/2
Parallel import licence number: 264/22