Zolpidem Zentiva: detailed information

Package leaflet: Information for the patient

Zolpidem Zentiva 10 mg film-coated tablets

Read this leaflet carefully before 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Zolpidem Zentiva is and what it is used for

Zolpidem Zentiva contains zolpidem tartrate, which belongs to a class of medicines called "Benzodiazepine-like drugs".
Zolpidem Zentiva is indicated for short-term treatment of sleep disorders (insomnia) in adults, only in cases where the sleep disturbances are severe, disabling or causing significant distress.
It must not be used for long periods. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.

2. What you should know before taking Zolpidem Zentiva

Do not take Zolpidem Zentiva

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 causing severe muscle weakness (myasthenia gravis),
breathing difficulties (acute and/or severe respiratory insufficiency),
if you suffer from brief episodes of breathing interruption during sleep (sleep apnoea syndrome),
if you have severe liver damage (severe hepatic insufficiency),
if you are a child or adolescent under 18 years of age,
if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Zolpidem Zentiva.
Before prescribing Zolpidem Zentiva, your doctor should try to identify and treat the underlying causes of sleep disturbances.
If sleep disturbances do not improve after 7–14 days of treatment, there may be an underlying psychiatric or physical condition that needs to be investigated.

Next-day psychomotor impairment (see also Driving and use of machinery)
Zolpidem Zentiva, like other medicines used to treat anxiety and/or insomnia, has central nervous system depressant effects.
The day after taking Zolpidem Zentiva, the risk of psychomotor impairment, including impaired ability to drive, may increase if you:

take this medicine less than 8 hours before performing activities requiring mental alertness,
take a higher dose than recommended,
take zolpidem while already taking other medicines with central nervous system depressant effects or other medicines that increase zolpidem blood levels, or while consuming alcohol or illicit psychoactive substances. Take the single dose immediately before going to bed. 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 Zolpidem Zentiva may lead to abuse and/or physical and psychological dependence (need to continue taking the medicine). The risk of dependence is higher when zolpidem is used for more than 4 weeks. The risk increases with higher doses and longer treatment duration. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or alcohol, illicit substances, or drug abuse.
Inform your doctor if you have ever had mental disorders or have abused or been dependent on alcohol, substances, or medicines.
If you have developed physical dependence, abruptly stopping treatment may cause withdrawal symptoms such as:

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

Rebound insomnia
Upon discontinuation of the medicine, a transient syndrome may occur, consisting of a return (in an intensified form) of the symptoms that led to treatment with the medicine. This may be accompanied by other reactions such as mood changes, anxiety, restlessness, or sleep disturbances.
This syndrome is more likely to occur if the medicine is stopped abruptly; therefore, discontinue Zolpidem Zentiva treatment gradually.
It is important that you are aware of the possibility of such disturbances occurring, to help reduce your anxiety.
Duration of treatment
The treatment duration should be as short as possible (see How to take Zolpidem Zentiva) and should not exceed 4 weeks, including the tapering-off phase. The treatment duration should not be extended beyond this period without your doctor re-evaluating your condition.
Initially, your doctor will explain that this treatment will be of limited duration and how you should gradually reduce the dose.
Memory disturbances (amnesia)
Zolpidem Zentiva may cause memory disturbances (anterograde amnesia). This effect most often occurs several hours after taking the medicine.
To reduce the risk, ensure you can sleep uninterrupted for 8 hours (see Possible side effects).
Other psychiatric reactions and "paradoxical" effects
During the use of benzodiazepines or medicines similar to Zolpidem Zentiva, the following may occur:

restlessness,
worsening of insomnia,
agitation,
irritability,
aggressiveness,
delirium,
anger,
nightmares,
hallucinations,
mental disorders (psychosis),
inappropriate behaviour.

If these disturbances occur, contact your doctor and stop using Zolpidem Zentiva.
The occurrence of these reactions is more likely in children and elderly patients.
Sleep disorders (sleepwalking) and associated behaviours
In patients taking zolpidem who were not fully awake, sleep disorders have been reported, characterized by walking during sleep (sleepwalking) and other associated behaviours such as driving while asleep, preparing and eating food, making phone calls, or engaging in sexual activity, without remembering the event.
Both the use of alcohol and other medicines acting on the central nervous system (CNS depressants) together with zolpidem, and the use of zolpidem at doses exceeding the recommended maximum dose, increase the risk of these behaviours (see "Zolpidem Zentiva with alcohol" and "Possible side effects").
If you experience these behaviours, contact your doctor, who may decide to discontinue your treatment with Zolpidem Zentiva.
Serious injuries
Zolpidem Zentiva may cause drowsiness and reduced consciousness, which may lead to falls and consequently to serious injuries.
Elderly patients
If you are elderly, your doctor will prescribe a lower dose (see How to take Zolpidem Zentiva).
Patients with respiratory problems
If you suffer from severe respiratory problems (chronic respiratory insufficiency), your doctor will prescribe Zolpidem Zentiva with caution, as it may depress respiratory function (see Possible side effects).
Patients with liver problems
If you suffer from severe liver problems (severe acute or chronic hepatic insufficiency), Zolpidem Zentiva is not indicated for you, as it may worsen brain damage (encephalopathy) (see Do not take Zolpidem Zentiva, How to take Zolpidem Zentiva, and Possible side effects).
Patients with psychotic disorders
Zolpidem Zentiva is not recommended as the primary treatment for psychotic disorders.
Patients with depression or anxiety associated with depression
Zolpidem Zentiva should not be used alone to treat depression or anxiety associated with depression, as suicidal tendencies may increase.
Zolpidem Zentiva, like other benzodiazepines and similar substances, should be administered with caution if you have depression or anxiety associated with depression.
If you are depressed, you may have suicidal tendencies, and therefore your doctor will prescribe the smallest possible amount of medicine: in this regard, it is recommended that you strictly follow your doctor's instructions.
Pre-existing depression may become apparent during the use of Zolpidem Zentiva.
Since insomnia may be a symptom of depression, your doctor will re-evaluate your condition if insomnia persists.
Possibility of suicide
Several studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicides in patients taking certain sedatives and hypnotics, including this medicine.
However, it has not been established whether this is caused by the medicine 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 or substance abuse
Zolpidem Zentiva should be used with caution if you have previously abused alcohol or illicit substances.
Patients with long QT syndrome
If you have a congenital condition called long QT syndrome, your doctor must carefully assess whether you can take zolpidem.
Children and adolescents
Zolpidem Zentiva must not be used in children and adolescents under 18 years of age (see Do not take Zolpidem Zentiva).
Other medicines and Zolpidem Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When taking zolpidem together with the following medicines, increased drowsiness and next-day psychomotor impairment, including impaired ability to drive, may occur (see Driving and use of machinery):

medicines for certain 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 anaesthesia,
medicines for hay fever, skin rashes, or other allergies that may cause drowsiness (sedating antihistamines). While taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).

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

highly effective painkillers (narcotic analgesics), as an increased sense of euphoria may occur, potentially increasing dependence (need to continue taking the medicine);
inhibitors and inducers of a liver protein (cytochrome CYP450), as substances inhibiting this protein may increase the activity of benzodiazepines or similar substances like Zolpidem Zentiva;
rifampicin (an antibiotic), as the effect of Zolpidem Zentiva decreases when taken with this medicine;
St. John’s wort, as the effect of Zolpidem Zentiva decreases when taken with this herbal remedy;
itraconazole (for fungal infections); the effect of Zolpidem Zentiva is not affected by this medicine;
ketoconazole (for fungal infections), as the concomitant administration of Zolpidem Zentiva and ketoconazole (200 mg twice daily) may increase the sedative effects of Zolpidem Zentiva.

Other medicines
The use of Zolpidem Zentiva together with opioids (strong painkillers, drugs for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, their combined use should only be considered when no other treatment options are available. However, if your doctor prescribes Zolpidem Zentiva together with opioids, your doctor will limit the dosage and duration of concomitant treatment.
Inform your doctor if you are taking opioid medicines and follow your doctor's dosage instructions carefully. It may be helpful to inform friends and family so 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 Zolpidem Zentiva is administered together with warfarin (to reduce blood clotting), digoxin (for heart failure treatment), or ranitidine (for stomach problems).
Zolpidem Zentiva with alcohol
Do not take Zolpidem Zentiva with alcohol, as the calming (sedative) effect may be increased if the medicine is taken together with alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Zolpidem Zentiva must not be taken during pregnancy (see Do not take Zolpidem Zentiva).
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, consult your doctor.
There is a risk that the baby may be harmed if this medicine is used during pregnancy. Some studies have shown an increased risk of cleft lip and palate (sometimes called "harelip") in newborns.
Reduced fetal movement and variability in fetal heart rate may occur after taking Zolpidem Zentiva during the second and/or third trimester of pregnancy.
If, for absolute medical necessity, Zolpidem Zentiva must be administered at the end of pregnancy or during childbirth, the baby may show:

muscle weakness,
lowered body temperature,
feeding difficulties,
breathing problems (respiratory depression).

If this medicine is taken regularly in the late stages of pregnancy, the baby may develop physical dependence and may be at risk of withdrawal symptoms such as agitation or tremors. In such cases, the newborn should be closely monitored during the postnatal period.
Severe respiratory depression may occur in the newborn if Zolpidem Zentiva has been used together with other medicines with central nervous system depressant effects at the end of pregnancy.
Breastfeeding
Zolpidem Zentiva passes into breast milk and therefore must not be taken during breastfeeding (see Do not take Zolpidem Zentiva).
Driving and use of machinery
Zolpidem Zentiva impairs the ability to drive vehicles and operate machinery, with the risk, for example, of "falling asleep at the wheel."
The day after taking Zolpidem Zentiva (as with other hypnotic medicines), you should be aware that:

you may feel drowsy, sleepy, dizzy, or confused,
you may take 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, operating machinery, or working at heights, to minimize the previously listed effects.

Do not drink alcohol or take other psychoactive substances while taking Zolpidem Zentiva, as the effects listed above may be intensified.
Zolpidem Zentiva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Zolpidem Zentiva

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

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

Use in patients with liver problems (hepatic insufficiency) who do not eliminate the
medicine as rapidly as normal subjects
the recommended dose is:
half a tablet (5 mg), which should only be exceeded in exceptional cases.

Zolpidem Zentiva should be taken:

as a single dose,
just before going to bed. Make sure you have at least an 8-hour period after taking this medicine before carrying out any activities requiring your alertness. Do not take another dose of Zolpidem Zentiva during the same night.

Use in children and adolescents
Zolpidem Zentiva must not be used in children and adolescents under 18
years of age (see "Do not take Zolpidem Zentiva").

If you take more Zolpidem Zentiva than you should
If you accidentally take or ingest an excessive dose of Zolpidem Zentiva,
contact your doctor immediately or go to the nearest hospital.
In cases of overdose (overdose) of Zolpidem Zentiva taken alone or in
combination with other medicines or substances that depress the activity of the Central Nervous
System (including alcohol), the following have been reported:

reduced level of consciousness up to coma;
severe disturbances that may lead to death.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
With Zolpidem Zentiva, dose-dependent side effects may occur, particularly affecting the Central Nervous System (CNS).
These effects:

are less pronounced if you take Zolpidem Zentiva immediately before going to bed or when you are already lying down,
occur more frequently if you are elderly.

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

drowsiness,
headache,
dizziness,
worsening of insomnia,
cognitive disturbances such as memory loss (anterograde amnesia), which may be associated with inappropriate behaviour,
hallucinations,
agitation,
nightmares,
depression (see "Warnings and precautions"),
fatigue,
vision problems (impaired vision),
diarrhoea,
nausea,
vomiting,
abdominal pain,
back pain,
respiratory tract infections (upper and lower).

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

altered sensation in parts of the body (paraesthesia),
tremor,
attention and speech disturbances,
confusion,
irritability,
restlessness,
aggression,
sleep disorders (sleepwalking – see "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 levels in liver blood tests,
appetite disturbances.

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

decreased level of consciousness,
changes in sexual desire,
disturbances in gait,
falls (especially in elderly patients and when Stilnox is not taken as prescribed) (see "Warnings and precautions"),
urticaria,
liver damage and bile flow impairment (hepatocellular, cholestatic and mixed liver injury) (see "Do not take Zolpidem Zentiva", "Warnings and precautions" and "How to take Zolpidem Zentiva").

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 from the available data)

anger,
abnormal behaviour,
loss of response (tolerance) to the medicine,
swelling of the face, throat or limbs, possibly with breathing difficulties (angioneurotic oedema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zolpidem Zentiva

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zolpidem Zentiva contains

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

Description of the appearance of Zolpidem Zentiva and package contents
Zolpidem Zentiva is available as
film-coated tablets.

Pack of 20 film-coated tablets of 10 mg
Pack of 30 film-coated tablets of 10 mg.

Marketing Authorization Holder
Zentiva Italia S.r.l. – Viale L. Bodio, 37/B – Milan
Manufacturer
Sanofi Winthrop Industrie - 30-36, Avenue Gustave Eiffel - Tours, France (pack of 30
tablets)
Delpharm Dijon - 6, Boulevard de l’Europe - Quetigny, France (packs of 20 and 30
tablets)