STILNOX 10 mg Film-Coated Tablets

Зміст інструкції

1. Stilnox 10 mg film-coated tablets
   1. What is Stilnox and what is it used for
   2. What you need to know before taking Stilnox
2. Stilnox may cause sleepwalking or other unusual behaviors during sleep (such as
3. Stilnox should not be used in children and adolescents under 18 years of age (see
   1. How to take Stilnox
   2. Possible side effects
   3. How to store Stilnox
   4. Contents of the pack and other information

Stilnox 10 mg film-coated tablets

zolpidem tartrate

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Stilnox is and what it is used for
• 2. What you need to know before you take 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 is Stilnox and what is it used for

Stilnox contains zolpidem tartrate which belongs to a class of medicines called
“Benzodiazepine-related drugs”.
Stilnox is indicated for the short-term treatment of sleep disorders (insomnia)
, only in cases where sleep disorders are severe, debilitating or such as to cause
profound discomfort.
It should not be used for long periods. Treatment should be as short as
possible, as the risk of dependence increases with the duration of treatment.

2. What you need to know before taking Stilnox

Do not take Stilnox

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from a disease that causes severe muscle weakness (myasthenia gravis),
• if you have difficulty breathing (acute and/or severe respiratory failure),
• if you suffer from brief pauses in breathing during sleep (sleep apnea syndrome),
• if you suffer from severe liver damage (severe hepatic insufficiency),
• if you are children or adolescents under the age of 18, if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”),

if you have already had episodes of sleepwalking or other unusual behaviors during sleep, while not fully awake, after taking Stilnox or other medicines containing zolpidem (see “Warnings and precautions”),

Warnings and precautions
Talk to your doctor or pharmacist before taking Stilnox.
Before prescribing Stilnox, the doctor must try to clarify and treat the causes of sleep disorders.
If, after a treatment of 7-14 days, sleep disorders do not improve, it is possible that the underlying disease has a psychiatric or physical cause that must be verified.

Psychomotor impairment the next day (see also “Driving and operating machinery”)
Stilnox, like other drugs used to treat anxiety and/or insomnia, has depressive effects on the central nervous system.
The day after taking Stilnox, the risk of psychomotor impairment, including impairment of the ability to drive, may increase if you:

• take this medicine less than 8 hours before performing activities that require mental alertness
• take a higher dose than recommended
• take zolpidem while already taking other medicines with a depressive effect on the central nervous system or other medicines that increase the levels of zolpidem in the blood, or while drinking alcohol, or while taking illicit narcotic substances. Take the single dose immediately at bedtime. Do not take another dose during the same night.

Tolerance:
After repeated use for several weeks, a certain reduction in the effect of this medicine may occur.

Dependence:
The use of Stilnox can lead to the development of abuse and/or physical and psychological dependence (the need to continue taking the medicine). Tell your doctor if you have ever had mental disorders, or have abused or been dependent on alcohol, substances or drugs. The risk of dependence is greater when zolpidem is used for more than 4 weeks. The risk of dependence increases the higher the dose and the longer the treatment. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or abuse of alcohol, illicit substances or drugs. If you have developed physical dependence, abrupt discontinuation of treatment will cause withdrawal symptoms, such as:

• headache,
• muscle pain,
• extreme anxiety,
• tension,
• agitation,
• confusion,
• irritability. In severe cases, the following disorders may occur:
• feeling detached from reality (derealization),
• feeling estranged from one's body (depersonalization),
• hearing disorders (hyperacusis),
• numbness and tingling in the extremities,
• hypersensitivity to light, noise and physical contact,
• hallucinations,
• seizures.

Rebound insomnia
Upon discontinuation of the medicine, a transient syndrome may occur consisting of the reappearance, in an aggravated form, of the disorders that led to treatment with the medicine. It may be accompanied by other reactions such as mood changes, anxiety and agitation, or sleep disorders.
This syndrome is more likely to occur if the medicine is discontinued abruptly; therefore, discontinue treatment with Stilnox gradually.
It is important that you are aware of the possibility of these disorders in order to reduce your anxiety.

Duration of treatment
The duration of treatment should be as short as possible (see “How to take Stilnox”) and should not exceed 4 weeks including the tapering off phase of the medicine.
The duration of treatment should not be prolonged beyond this period without the doctor having reassessed your situation.
At the beginning, the doctor will explain to you that this treatment will be of limited duration and how you should gradually reduce the dose.

Memory disorders (amnesia):
Stilnox can cause memory disorders (anterograde amnesia). In most cases, this effect occurs several hours after taking the medicine.
To reduce the risk, make sure you can sleep uninterruptedly for 8 hours (see “Possible side effects”).

Other psychiatric and “paradoxical” reactions:
During the use of benzodiazepines or medicines similar to Stilnox, the following may occur:

• restlessness,
• worsening of insomnia,
• agitation,
• irritability,
• aggressiveness,
• delusions,
• anger,
• nightmares,
• hallucinations,
• mental disorders (psychosis),
• inappropriate behavior.

If these disorders occur, contact your doctor and stop using Stilnox.
The occurrence of these reactions is more likely in children and the elderly.

Sleep disorders (sleepwalking) and associated behaviors:

Stilnox may cause sleepwalking or other unusual behaviors during sleep (such as

driving, eating, making a phone call, or having sexual intercourse) while not being
fully awake. You may not remember what you did during the night the morning after. If any of the above conditions should occur, immediately stop treatment with Stilnox and contact your doctor as these
sleep behaviors could seriously put you at risk of causing injury to yourself
or others (see “Do not take Stilnox”).
Both drinking alcohol or taking other medicines that make you sleepy together with Stilnox, and using
Stilnox at doses that exceed the maximum recommended dose, increase the risk that these
sleep behaviors will occur. (see “Stilnox with alcohol” and “Possible side effects”).

Serious injuries:
Stilnox can cause drowsiness and reduced level of consciousness, which can lead to
falls and consequently serious injuries

Elderly patients:
If you are an elderly patient, your doctor will prescribe a lower dose (see “How
to take Stilnox”).

Patients with breathing problems
If you suffer from severe breathing problems (chronic respiratory failure), your doctor will
prescribe Stilnox with caution, as it may depress respiratory function (see
“Possible side effects”).

Patients with liver problems
If you suffer from severe liver problems (severe hepatic insufficiency, acute or chronic), Stilnox
is not indicated for you because it may worsen brain damage
(encephalopathy) (see “Do not take Stilnox”, “How to take Stilnox” and “Possible side effects”).

Patients with psychotic illnesses
Stilnox is not recommended as the main treatment for psychotic illnesses.

Patients with depression or anxiety associated with depression
Stilnox should not be used alone for the treatment of depression or anxiety
associated with depression, as it may increase suicidal tendencies.
Stilnox, like other benzodiazepines and similar substances, must be administered with
caution if you have depression or anxiety associated with depression.
If you are depressed, you may have suicidal tendencies and consequently your doctor will prescribe
you the minimum amount of medication: in this regard, it is recommended to strictly follow
your doctor's instructions.
A pre-existing depression may be revealed during the use of Stilnox. Since
insomnia can be a symptom of depression, your doctor will re-evaluate your case if
insomnia persists.

Possibility of suicide
Several studies have shown an increased risk of suicidal ideation, suicide attempts and suicides in patients taking certain sedatives and hypnotics, including this
medicinal product. However, it has not been established whether this is caused by the medicinal product or whether there may be another
reason. If you have suicidal thoughts, contact your doctor as soon as possible for
further consultation.

Patients with a history of alcohol and substance abuse
Stilnox must be used with caution if you have previously abused alcohol or drugs.

Patients with long QT syndrome
If you have a congenital syndrome called long QT syndrome, your doctor will need to
carefully assess whether you can take zolpidem.

Children and adolescents

Stilnox should not be used in children and adolescents under 18 years of age (see

“Do not take Stilnox”).

Other medicines and Stilnox
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine.
When taking zolpidem with the following medicines, increased effects of
drowsiness and psychomotor impairment may occur the next day, including
impairment of the ability to drive (see “Driving and using machines”):

• medicines for some mental health problems (antipsychotics)
• medicines for sleep problems (hypnotics)
• medicines to calm or reduce anxiety
• medicines for depression
• medicines for moderate to severe pain (narcotic analgesics)
• medicines for epilepsy
• medicines used for anesthesia
• medicines for hay fever, skin rashes or other allergies, which can cause drowsiness (sedating antihistamines). While you are taking zolpidem with antidepressant medicines, including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not there (hallucinations).

It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
The effects of Stilnox may also be influenced by or influence the following medicines:

• highly effective painkillers (narcotic analgesics), as an increase in the feeling of euphoria may also occur, which can lead to increased dependence (need to continue taking the medicine);
• inhibitors and stimulators of a protein present in the liver (cytochrome CYP450), as substances that inhibit this protein may increase the activity of benzodiazepines or similar substances, such as Stilnox;
• rifampicin (an antibiotic) as the effect of Stilnox decreases in association with this medicine;
• St John's wort, the effect of Stilnox decreases in association with this medicine;
• itraconazole (for fungal infections); the effect of Stilnox is not affected by this medicine;
• ketoconazole (for fungal infections) because the concomitant administration of Stilnox and ketoconazole (200 mg twice a day) may increase the sedative effects of Stilnox.

Other medicines

• The use of Stilnox together with opioids (strong painkillers, medicines for substitution therapy

and some medicines against cough) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For
this reason, their use together should only be considered when other treatment options are not possible. However, if
your doctor prescribes Stilnox together with opioids, your doctor will limit the dosage and duration
of concomitant treatment.
Tell your doctor if you are taking opioid medicines and carefully follow your doctor's advice on dosage. It is helpful to inform friends and relatives so that they are aware of the
signs and symptoms listed above. Contact your doctor if you experience these symptoms.

• No significant interactions have been observed when Stilnox is administered in association with warfarin (to decrease blood clotting), digoxin (for the treatment of heart failure) or ranitidine (for stomach problems).

Stilnox with alcohol
Do not take Stilnox with alcohol as the calming (sedative) effect may be
increased if the medicine is taken with alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.

Pregnancy
Stilnox should not be taken during pregnancy (see “Do not take Stilnox”).
If you are pregnant, suspect or are planning a pregnancy, ask your doctor for advice.
If used during pregnancy, there is a risk that the child may be harmed. Some
studies have shown that the risk of cleft lip and palate (sometimes called "harelip") may increase in the newborn.
Decreased fetal movement and variability in fetal heart rate may
occur after taking Stilnox during the second and/or third trimester of pregnancy.
If, for absolute medical necessity, Stilnox must be administered at the end of
pregnancy, or during labor, the baby may show:

• muscle weakness,
• lowering of body temperature,
• difficulty feeding,
• breathing problems (respiratory depression).

If this medicine is taken regularly in the late stages of pregnancy, the
child may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn must be carefully
monitored during the postnatal period.
Severe respiratory depression may occur in the newborn when Stilnox has been used
with other medicines with a depressing effect on the Central Nervous System at the end of
pregnancy.

Breastfeeding
Stilnox passes into breast milk, therefore it should not be taken during breastfeeding
(see “Do not take Stilnox”).

Driving and using machines
Stilnox impairs the ability to drive and operate machinery, with the risk of
for example, "falling asleep at the wheel".
The day after taking Stilnox (as with other hypnotic medicines), you should be aware that:

• you may feel drowsy, sleepy, dizzy or confused
• it may take you longer to make decisions
• your vision may be blurred or double
• you may feel less alert A period of at least 8 hours is recommended between taking zolpidem and driving vehicles, operating machinery and working at height, to minimize the effects listed above. Do not drink alcohol or take other psychoactive substances while taking Stilnox, as the effects listed above may be potentiated

Stilnox contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before
taking this medicine.

Stilnox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially ‘sodium-free’.

3. How to take Stilnox

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The duration of treatment should be as short as possible.
Generally, this duration varies from a few days to two weeks, with a maximum of four
weeks including the phase of discontinuing the medicine.
Sometimes the doctor may prolong the maximum treatment period; in this case,
follow the doctor's instructions scrupulously.
The recommended dose is 10 mg (1 tablet) of Stilnox per day. Do not exceed the dose of
10 mg every 24 hours.
A lower dose may be prescribed to certain patients.

Use in elderly or debilitated patients
If you are elderly or debilitated, you may be particularly sensitive to the effects of Stilnox;
the recommended dose is:
half a tablet (5 mg), which will only be exceeded in exceptional cases.

Use in patients with liver problems (hepatic insufficiency) who do not eliminate the

medicine as quickly as normal subjects
The recommended dose is:
half a tablet (5 mg), which will only be exceeded in exceptional cases.
Stilnox should be taken:

• with a single administration,
• just before bedtime. Make sure you have at least 8 hours after taking this medicine before performing activities that require your attention. Do not take another dose of Stilnox during the same night.

Use in children and adolescents
Stilnox should not be used in children and adolescents under 18 years of age (see
“Do not take Stilnox”).

If you take more Stilnox than you should
In case of accidental ingestion/intake of an excessive dose of Stilnox, immediately inform
your doctor or go to the nearest hospital.
In case of taking an excessive dose (overdose) of Stilnox alone or in
association with other medicines or substances that depress the activity of the Central Nervous
System (including alcohol), the following have been reported:

• a reduction in the state of consciousness up to coma;
• serious disturbances that can lead to death.

If you forget to take Stilnox
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
With Stilnox there may be side effects dependent on the dose, in particular affecting the Central Nervous System (CNS).
These effects:

• are of a lesser extent if you take Stilnox immediately before going to bed or when you are already in bed,
• occur more frequently if you are elderly.

Common side effects (may affect up to 1 in 10 people)

• sleepiness,
• headache,
• dizziness,
• increased insomnia,
• cognitive disorders (cognitive impairment) such as memory loss (anterograde amnesia) which may be associated with inappropriate behavior,
• hallucinations,
• agitation,
• nightmares,
• depression (see “Warnings and precautions”),
• fatigue,
• visual disturbances (impaired vision),
• diarrhea,
• nausea,
• vomiting,
• abdominal pain,
• back pain,
• respiratory tract infection (upper and lower).

Uncommon side effects (may affect up to 1 in 100 people)

• altered sensitivity of some parts of the body (paresthesia),
• tremor,
• attention and speech disorders,
• confused state,
• irritability,
• restlessness,
• aggression,
• sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making a phone call or having sexual intercourse) while not fully awake, (see “Do not take Stilnox” and “Warnings and precautions”),
• euphoria,
• double vision (diplopia),
• blurred vision,
• joint pain (arthralgia),
• muscle pain (myalgia),
• involuntary muscle contractions (muscle spasms),
• neck pain,
• muscle weakness,
• skin irritations (rash),
• itching,
• excessive sweating (hyperhidrosis),
• increased values in some blood tests for the liver,
• appetite disorders.

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

• decreased level of consciousness,
• decreased libido,
• altered gait,
• falls (especially in elderly patients and when Stilnox is not taken as prescribed) (see “Warnings and precautions”),
• urticaria,
• liver and bile flow damage (hepatocellular, cholestatic and mixed liver damage) (see “Do not take Stilnox”, “Warnings and precautions” and “How to take Stilnox”).

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

• delirium,
• dependence (after discontinuation of treatment, withdrawal syndrome or rebound effects may occur. See “Warnings and precautions”),
• respiratory depression (see “Warnings and precautions”).

Side effects with unknown frequency (frequency cannot be estimated on the basis of
available data)

• anger,
• abnormal behavior,
• delirium (a sudden and serious change in mental state that causes a person to appear confused or disoriented),
• loss of response (tolerance) to the medicine,
• swelling of the face, throat, limbs, with possible difficulty breathing (angioedema).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Stilnox

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Stilnox contains

• The active ingredient is zolpidem tartrate. One film-coated tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are: lactose monohydrate; microcrystalline cellulose; hypromellose; sodium carboxymethylcellulose (type A); magnesium stearate. Tablet coating: hypromellose; titanium dioxide (E171); macrogol 400.

Description of the appearance of Stilnox and contents of the pack
Stilnox is presented in the form of
Film-coated tablets.

• pack of 14 film-coated tablets containing 10 mg
• pack of 20 film-coated tablets containing 10 mg
• pack of 30 film-coated tablets containing 10 mg. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi S.r.l. – Viale L. Bodio, 37/B – Milan

Manufacturer
Sanofi Winthrop Industrie - 30-36, Avenue Gustave Eiffel - Tours France
Delpharm Dijon - 6, Boulevard de l’Europe - Quetigny France