Zolpidem EG: detailed information

Package leaflet: Information for the user

ZOLPIDEM EG 10 mg Film-coated tablets

Generic medicine
Please 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if
their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What ZOLPIDEM EG is and what it is used for

Zolpidem belongs to a group of medicines called benzodiazepine-like drugs.
ZOLPIDEM EG is a hypnotic medicine (sleeping pill) that acts on the brain to induce sleepiness. It is
used for the short-term treatment of insomnia in adults, only in cases where sleep disturbances are
severe, disabling or causing significant distress.

2. What you need to know before taking ZOLPIDEM EG

Do not take ZOLPIDEM EG
if you are allergic (hypersensitive) to zolpidem tartrate or to any of the other ingredients of
this medicine (listed in section 6 below). Signs of an allergic reaction include:
skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue;
if you have ever experienced sleepwalking or other unusual sleep-related behaviors (such as
driving, eating, making phone calls or having sex, etc.) while not fully awake after taking ZOLPIDEM EG or other medicines containing zolpidem;
if you suffer from certain forms of pathological muscle weakness (myasthenia gravis);
if you have brief episodes of breathing cessation during sleep (sleep apnoea syndrome);
if you have acute and/or severe respiratory problems (respiratory failure);
if you have severe liver problems (hepatic insufficiency).
Do not take this medicine if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking ZOLPIDEM EG if:
you have liver problems
you have kidney problems
you have respiratory problems (respiratory failure)
you suffer from depression or have had another mental illness, anxiety or psychotic disorder in
the past. Zolpidem may mask or worsen symptoms
you have or have previously had thoughts of self-harm or suicide
Some studies have shown an increased risk of suicidal ideation, suicide attempts and suicide in patients taking certain sedatives and hypnotics, including this medicine. If you have suicidal thoughts, contact your doctor as soon as possible for further advice
you have recently taken ZOLPIDEM EG or similar medicines for more than 4 weeks
you are elderly or frail. If you get up at night, be cautious. ZOLPIDEM EG may relax your muscles.
This, together with its sedative effect, increases the risk of falls and consequently of hip fractures. Your doctor may prescribe a lower dose (see section 3 “How to take ZOLPIDEM EG”)
you have ever had heart problems, including slow or irregular heartbeat
you have ever had a mental disorder or have abused or been dependent on alcohol or drugs.

Next-day psychomotor impairment (see also Driving and use of machines)
The day after taking ZOLPIDEM EG, 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;
you take a higher dose than recommended;
you take zolpidem while already taking other medicines with central nervous system depressant effects or other medicines that increase zolpidem blood levels, or while drinking alcohol, or while using illicit substances.

Take a single dose immediately at bedtime.
Do not take another dose during the same night.

Other considerations

Tolerance – if after a few weeks you notice that the tablets are no longer working as effectively as when you started treatment, consult your doctor.
Dependence – when taking medicines of this type, there is a risk of developing abuse and dependence, which increases with dosage and duration of treatment. The risk is higher if you have a history of psychiatric disorders or substance dependence, or alcohol, drug or medication abuse. However, dependence may also occur at normal therapeutic doses or in the absence of risk factors such as prior alcohol or drug abuse.
Discontinuation – treatment should be stopped gradually. Upon discontinuation, a short-term syndrome may occur, whereby the symptoms that led to
treatment with ZOLPIDEM EG reappear in an intensified form (withdrawal phenomenon).
It may be accompanied by other reactions such as mood changes, anxiety and agitation.
These symptoms may occur between doses of this medicine, especially when the dosage is high.
Amnesia – This medicine may cause memory loss. To reduce this risk, you should ensure you can have an uninterrupted 8-hour sleep period.
Psychiatric reactions and “paradoxical” reactions – ZOLPIDEM EG may cause undesirable behavioral effects such as restlessness, agitation, irritability, aggression, delusions (false beliefs), anger outbursts, nightmares, hallucinations (seeing, hearing or perceiving things that are not there), psychosis, inappropriate behavior, worsening of insomnia.
Sleepwalking and other related behaviors – This medicine may cause people to perform actions while asleep that they do not remember upon waking. This includes sleepwalking, driving while asleep, preparing and eating food, making phone calls or having sex without being fully awake. Stop taking this medicine and contact your doctor as soon as possible if such behaviors occur. Alcohol, certain medicines used to treat depression or anxiety, or taking ZOLPIDEM EG at doses above the maximum recommended dose may increase the risk of these adverse effects.
Risk of falls and serious injuries – This medicine may cause drowsiness and reduced consciousness, which may increase the risk of falling and consequently of sustaining serious injuries (see also section 4 “Possible side effects”).

If your insomnia symptoms persist after a treatment course of 7–14 days, contact your doctor so that treatment can be reassessed.
If you are unsure whether any of the above cases apply to you, consult your doctor or pharmacist before taking ZOLPIDEM EG.

Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.

Other medicines and ZOLPIDEM EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines without a prescription, including herbal products. This is because ZOLPIDEM EG may affect how some other medicines work. In addition, some medicines may affect how ZOLPIDEM EG works.
The combination of ZOLPIDEM EG with other medicines having central nervous system depressant effects must be used with caution (see section 2 “What you need to know before taking ZOLPIDEM EG”).
Concomitant use of ZOLPIDEM EG and opioids (strong painkillers, medicines 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, concomitant use should only be considered when no other therapeutic options are possible.
However, if your doctor prescribes ZOLPIDEM EG together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if such symptoms occur.
Inform your doctor if you are taking any of the following medicines:
When taking ZOLPIDEM EG together with the following medicines, increased drowsiness and next-day psychomotor impairment, including impaired ability to drive, may occur:

Medicines for certain mental health conditions (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 may cause drowsiness (sedating antihistamines)

When taking ZOLPIDEM EG with antidepressants, including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not there (hallucinations).
The concomitant use of ZOLPIDEM EG with fluvoxamine or ciprofloxacin is not recommended.
The following medicines may increase the likelihood of adverse effects when taken with ZOLPIDEM EG:

Medicines that inhibit liver enzymes. Ask your doctor or pharmacist which medicines have this effect (e.g., ketoconazole, a medicine used to treat fungal infections). To reduce this risk, your doctor may decide to reduce the dose of ZOLPIDEM EG.

The following medicines may reduce the effectiveness of ZOLPIDEM EG:

Rifampicin (an antibiotic) – for infections
St. John’s wort (a herbal medicine) – for mood swings and depression – concomitant use of ZOLPIDEM EG and St. John’s wort is not recommended.

ZOLPIDEM EG with food, drinks and alcohol
Do not drink alcohol during treatment with ZOLPIDEM EG. Alcohol may enhance the effects of ZOLPIDEM EG, causing you to sleep so deeply that you cannot breathe properly or have difficulty waking up.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning a pregnancy, consult your doctor.
The use of ZOLPIDEM EG is not recommended during pregnancy.
Reduced fetal movement and decreased variability in fetal heart rate may occur after taking ZOLPIDEM EG during the second and/or third trimester of pregnancy.
If ZOLPIDEM EG is taken towards the end of pregnancy or during childbirth, the baby may show muscle weakness, low body temperature, feeding difficulties and 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 developing withdrawal symptoms such as agitation or tremors. In this case, the newborn must be closely monitored during the postnatal period.
Do not take ZOLPIDEM EG if you are breastfeeding. This is because small amounts may pass into breast milk.

Driving and use of machines
ZOLPIDEM EG impairs the ability to drive vehicles and operate machinery, including the risk of "falling asleep at the wheel." On the day following the intake of ZOLPIDEM EG (as with other hypnotic medicines), you should be aware that:

you may feel drowsy, sleepy, dizzy or confused
you may need more time to make decisions
your vision may be blurred or double
you may feel less alert
An interval of at least 8 hours is recommended between taking zolpidem and driving, operating machinery or working at heights, in order to minimize the previously listed effects. Do not drink alcohol or take other psychoactive substances while taking ZOLPIDEM EG, as the effects listed above may be intensified.

For further information on possible side effects that may affect driving, see section 4 of this leaflet.

ZOLPIDEM EG contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take ZOLPIDEM EG

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults:
The recommended dose every 24 hours is 10 mg of ZOLPIDEM EG. A lower dose may be prescribed for certain patients.
ZOLPIDEM EG 10 mg tablets can be divided into equal doses (5 mg each) along the score line.
Do not exceed 10 mg every 24 hours.

Elderly and debilitated patients:
The usual dose is 5 mg of zolpidem tartrate, taken immediately before bedtime.

Patients with liver problems:
The usual initial dose is 5 mg of zolpidem tartrate taken immediately before bedtime. Your doctor may decide to increase it to 10 mg of zolpidem tartrate if considered safe.

Maximum dose:
Under no circumstances should the daily dose of 10 mg of zolpidem tartrate be exceeded.

Use in children and adolescents:
ZOLPIDEM EG is not recommended for children and adolescents under 18 years of age.

Method of administration:
The film-coated tablet must be taken with liquid immediately before going to bed.
ZOLPIDEM EG should be taken:

as a single dose
shortly before bedtime

Ensure you have a period of at least 8 hours after taking this medicine before engaging in any activities requiring alertness.

How long should ZOLPIDEM EG be taken?
The duration of treatment should be as short as possible. Generally, it ranges from a few days to 2 weeks, with a maximum of 4 weeks including the gradual withdrawal phase of the drug.
Sometimes it may be necessary to extend the maximum treatment period. Your doctor will decide on this only after re-evaluating your condition.

If you take more ZOLPIDEM EG than you should
If you take an excessive dose of ZOLPIDEM EG, inform your doctor immediately or go to the nearest hospital. Take the packaging with you so that the doctor knows what you have taken. Have someone accompany you when going to the doctor.
Taking an excessive dose of ZOLPIDEM EG can be very dangerous. The following effects may occur:

Drowsiness, confusion, deep sleep, and risk of entering a fatal coma

If you forget to take ZOLPIDEM EG
ZOLPIDEM EG should only be taken at bedtime. If you forget to take the tablet before going to bed, do not take it at any other time, otherwise you may feel sleepy, drowsy, and confused during the day. Take the missed dose only if you are still able to have 8 hours of uninterrupted sleep. If this is not possible, take the next dose at bedtime the following evening. Do not take a double dose to make up for the missed dose.

If you stop taking ZOLPIDEM EG
Treatment should be discontinued gradually, as the symptoms for which you are being treated may return more intensely (rebound insomnia). In addition, anxiety, restlessness, and mood disturbances may occur. These effects will disappear over time.
If you have become dependent on ZOLPIDEM EG, abruptly stopping treatment may cause adverse effects such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, and insomnia. In severe cases, other effects may occur, such as hypersensitivity to light, noise, and physical touch, abnormally increased auditory acuity and painful perception of sound, hallucinations, numbness and tingling in the extremities, derealization (feeling that the surrounding world is not real), depersonalization (feeling that the mind seems detached from the body), or seizures (violent attacks or convulsions). These symptoms may occur between doses, especially if the dosage is high.

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.
These effects appear to be related to individual sensitivity and seem to occur more frequently within one hour after taking the tablet if you do not lie down or fall asleep immediately.
Such effects occur more frequently in elderly patients.
Stop taking ZOLPIDEM EG and contact a doctor immediately or go to hospital if:

you have an allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue (angioedema). The frequency of this side effect is not known (frequency cannot be estimated from the available data).

Common (may affect up to 1 in 10 people)

Memory disturbances such as poor memory (amnesia), impaired memory, inability to recall recent events (anterograde amnesia). This is more likely to occur in the hours following administration of this medicine. If you get 8 hours of sleep after taking ZOLPIDEM EG, it is less likely to cause problems.
Worsening of sleep problems after taking this medicine.
Seeing or hearing things that are not really there (hallucinations)
Drowsiness or strong desire to sleep (may also occur the next day)
Dizziness
Blurred vision or double vision
Diarrhoea
Feeling unwell (nausea) or illness (vomiting)
Abdominal pain
Lung and main airway infections (respiratory tract infections)
Headache
Feeling of tiredness
Feeling of restlessness
Nightmares
Depression
Back pain
Reduced alertness
Movement disorders (ataxia)
Sensation of spinning (vertigo)

Uncommon (may affect up to 1 in 100 people)

Changes in appetite (appetite disturbance)
Sleep-driving and other unusual behaviours (sleep-walking, having sex while asleep)
Feeling of intense euphoria or self-confidence (euphoria)
Gait disturbances and falls, especially in the elderly
Feeling confused or irritable
Feeling restless or angry
Attention disturbance
Difficulty speaking
Joint or muscle pain, muscle spasms
Neck pain
Unusual sensation or tingling of the skin (paraesthesia)
Tremors
Changes in liver enzyme levels (increase) – shown in blood test results
Itchy skin or rash
Excessive sweating
Muscle weakness

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

Decreased ability to see (visual impairment)
Reduced awareness of the surrounding environment
Changes in sexual desire (libido)
Hives (urticaria)
Liver damage (of hepatocellular, cholestatic or mixed type)

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

Dependence on ZOLPIDEM EG, leading to a perceived need to take the medicine to feel normal (see section 2 "Warnings and precautions")
Difficulty breathing (respiratory depression)
Believing things that are not true (delusion)

Not known (frequency cannot be estimated from the available data)

Feeling angry or displaying unusual behaviour
ZOLPIDEM EG has less than normal effect (tolerance, see section 2 “Warnings and precautions”).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 ZOLPIDEM EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister.
The first two digits indicate the month and the last four digits the year. The expiry date refers to
the last day of that month.
Store in the original packaging.
Do not dispose of any medicine 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 EG contains
The active substance is zolpidem tartrate.
One film-coated tablet contains 10 mg of zolpidem tartrate.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch (type A), hypromellose, and magnesium stearate.
Film coating: titanium dioxide (E171), hypromellose, and macrogol 400.

Description of the appearance of ZOLPIDEM EG and contents of the pack
ZOLPIDEM EG 10 mg film-coated tablets are white to almost white, oval, biconvex, with a score line on both sides and engraved with "ZIM" and "10" on one side. The tablet can be divided into equal doses.
ZOLPIDEM EG film-coated tablets are available in:

Boxes containing 10, 14, 15, 20, 28, 30, 50, 100 tablets in blisters.
Containers containing 30, 100 or 500 tablets, sealed with child-resistant closure.

Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy

Manufacturers
Synthon Hispania Poligono Las Salinas 08830 Sant Boi de Llobregat – Spain
Centrafarm Services B.V., Nieuwe Donk 9, 4879 Ac Etten-Leur - The Netherlands
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel - Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany Zolpidem AL 5/10 mg Film Tablets
Italy Zolpidem EG 10 mg film-coated tablets
The Netherlands Zolpidemtartrate CF 5/10 mg, film-coated tablets