Zolprem

Patient Information Leaflet

ZOLPREM 10 mg/ml oral drops, solution

Zolpidem tartrate
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine, as 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. Never give it to other people, even if their symptoms are the same as yours, as it could 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:

1. What Zolprem is and what it is used for
2. What you need to know before taking Zolprem
3. How to take Zolprem
4. Possible side effects
5. How to store Zolprem
6. Contents of the pack and other information

1. What Zolprem is and what it is used for

Zolprem contains the active substance zolpidem tartrate, which belongs to a class of medicines called
"benzodiazepine-like drugs".
Zolprem is indicated for short-term treatment of sleep disorders (insomnia) in adults, only
in cases where the sleep disturbances are severe, disabling or causing marked 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 Zolprem

Do not take Zolprem

• if you are allergic to zolpidem tartrate 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),
• if you have breathing difficulties (acute and/or severe respiratory insufficiency),
• if you suffer from brief episodes of breathing cessation 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"),
• if you have previously experienced episodes of sleepwalking or other unusual behaviours during sleep while not fully awake, after taking Zolprem or other medicines containing zolpidem (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before taking Zolprem.

Before prescribing Zolprem, your doctor should try to identify and treat the underlying causes of sleep disorders.
If your sleep problems 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 machines”)
Zolprem, like other medicines used to treat anxiety and/or insomnia, has central nervous system depressant effects.
The day after taking Zolprem, the risk of psychomotor impairment, including impaired ability to drive, may increase if you:

• take this medicine less than 8 hours before performing tasks requiring mental alertness,
• take a higher dose than recommended,
• take zolpidem together with other medicines that depress the central nervous system or other medicines that increase zolpidem blood levels, or while drinking alcohol, or while using 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 Zolprem may lead to abuse and/or physical and psychological dependence (need to continue taking the medicine).
Inform your doctor if you have ever had mental health disorders or have abused or been dependent on alcohol, drugs, or medicines. The risk of dependence is higher when zolpidem is used for more than 4 weeks. The risk of dependence increases with higher doses and longer treatment duration. The risk of abuse and dependence is greater in patients with a history of mental health disorders and/or abuse of alcohol, illicit substances, or medicines. If physical dependence has developed, 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 disorders (hyperacusis),
• numbness and tingling in the extremities,
• hypersensitivity to light, noise, and physical contact,
• hallucinations,
• epileptic seizures.

Rebound insomnia
When stopping the medicine, a transient syndrome may occur, consisting of a return of the symptoms that led to treatment, often in a more intense form. 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 Zolprem treatment gradually.
It is important that you are aware of the possibility of such symptoms occurring, to help reduce your anxiety.

Duration of treatment
The treatment duration should be as short as possible (see "How to take Zolprem") and should not exceed 4 weeks, including the tapering-off phase. The treatment should not be extended beyond this period without your doctor re-evaluating your condition.
At the beginning, your doctor will explain that this treatment will be of limited duration and how you should gradually reduce the dose.

Memory disturbances (amnesia)
Zolprem 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 Zolprem, the following may occur:

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

If any of these occur, contact your doctor and stop using Zolprem.
These reactions are more likely to occur in children and elderly patients.

Sleep disorders (sleepwalking) and associated behaviours:
Zolprem may cause sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or having sexual intercourse) while not fully awake. The next morning, you may not remember what you did during the night. If any of the above conditions occur, stop treatment with Zolprem immediately and contact your doctor, as these sleep-related behaviours may seriously increase your risk of causing injury to yourself or others (see "Do not take Zolprem").
Both drinking alcohol or taking other sedating medicines together with Zolprem, and using Zolprem at doses exceeding the maximum recommended dose, increase the risk of these sleep-related behaviours occurring (see "Zolprem with alcohol" and "Possible side effects").

Serious injuries
Zolpidem may cause drowsiness and reduced consciousness, which may 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 Zolprem").

Patients with respiratory problems
If you suffer from severe respiratory problems (chronic respiratory insufficiency), your doctor will prescribe Zolprem cautiously, 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), Zolprem is not recommended for you, as it may worsen brain damage (encephalopathy) (see "Do not take Zolprem", "How to take Zolprem", and "Possible side effects").

Patients with psychotic disorders
Zolprem is not recommended as the primary treatment for psychotic disorders.

Patients with depression or anxiety associated with depression
Zolprem should not be used alone to treat depression or anxiety associated with depression, as it may increase suicidal tendencies.
Zolprem, 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 necessary 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 Zolprem.
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 suicide 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 evaluation.

Patients with a history of alcohol or drug abuse
Zolprem should be used with caution if you have previously abused alcohol or drugs.

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

Other medicines and Zolprem
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 machines"):

• medicines for certain mental health conditions (antipsychotics),
• medicines for sleep problems (hypnotics),
• medicines to calm or reduce anxiety,
• antidepressants,
• 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).

When taking zolpidem together 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 Zolprem 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 the risk of dependence (need to continue taking the medicine);
• inhibitors and inducers of a liver protein (cytochrome CYP450), as substances that inhibit this protein may increase the activity of benzodiazepines or similar substances like Zolprem;
• rifampicin (an antibiotic), as the effect of Zolprem decreases when taken with this medicine;
• St. John’s wort, as the effect of Zolprem decreases when taken with this herbal remedy;
• itraconazole (for fungal infections); the effect of Zolprem is not affected by this medicine;
• ketoconazole (for fungal infections), as concomitant administration of Zolprem and ketoconazole (200 mg twice daily) may increase the sedative effects of Zolprem.

Other medicines

• The use of Zolprem together with opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Zolprem together with opioids, they will limit the dose and duration of concomitant treatment. Inform your doctor if you are taking opioid medicines and follow their dosage instructions carefully. It may be helpful to inform family and friends so they are aware of the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
• No significant interactions have been observed when Zolprem is taken with warfarin (to reduce blood clotting), digoxin (for heart failure treatment), or ranitidine (for stomach problems).

Zolprem with food, drinks, and alcohol
Do not take Zolprem with alcohol, as the calming (sedative) effect may be increased when the medicine is taken with alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Zolprem must not be taken during pregnancy (see "Do not take Zolprem").
If you are pregnant, think you may be pregnant, or are planning a pregnancy, consult your doctor.
There is a risk to the unborn baby if Zolprem is used during pregnancy. Some studies have shown an increased risk of cleft lip and palate (sometimes called "harelip") in the newborn.
Reduced fetal movement and changes in fetal heart rate variability may occur after taking Zolprem during the second and/or third trimester of pregnancy.
If, for essential medical reasons, Zolprem must be administered towards the end of pregnancy or during delivery, the baby may show:

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

If this medicine is taken regularly during the late stages of pregnancy, the baby may develop physical dependence and may be at risk of withdrawal symptoms such as restlessness or tremors. In such cases, the newborn should be closely monitored during the postnatal period.
Severe respiratory depression in the newborn may occur when Zolprem is used together with other central nervous system depressant medicines towards the end of pregnancy.

Breastfeeding
Zolprem passes into breast milk and therefore must not be taken during breastfeeding (see "Do not take Zolprem").

Driving and use of machines
Zolprem impairs the ability to drive and use machinery, with a risk, for example, of "falling asleep at the wheel".
On the day after taking Zolprem (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.

A minimum of 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 Zolprem, as the effects listed above may be intensified.

Zolprem contains Sodium Benzoate
This medicine contains 0.25 mg of Sodium Benzoate per ml.
This medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e., essentially "sodium-free".

3. How to take Zolprem

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment should be as short as possible.
Usually, this duration ranges from a few days to two weeks, with a maximum of four weeks including the medication withdrawal phase.
Sometimes your doctor may extend the maximum treatment period; in such cases, follow your doctor's instructions precisely.
The recommended dose is 10 mg (25 drops) of Zolprem per day. Do not exceed the dose of 10 mg (25 drops) every 24 hours.
To dispense the prescribed dose of the medicine, hold the bottle in an upright position with the opening facing downwards.
After dispensing the number of drops corresponding to the prescribed dose, stop the administration of the medicine by returning the bottle with the opening facing upwards. If the liquid does not come out of the bottle (small air bubbles or liquid may block the passage through the dropper), wait a few moments without shaking the bottle. To facilitate the release of the liquid, close the bottle, turn it upside down several times, or gently tap it with a finger, then repeat the dispensing as described above.
The recommended dose is 10 mg (25 drops) of Zolprem per day.
Do not exceed the dose of 10 mg (25 drops) in 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 Zolprem; the recommended dose is 5 mg (12–13 drops), which should be exceeded only 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 5 mg (12–13 drops), which should be exceeded only in exceptional cases.

Zolprem should be taken:

• as a single administration,
• just before going to bed.

Ensure you allow at least 8 hours after taking this medicine before performing any activities requiring your attention and vigilance.
Do not take another dose of Zolprem during the same night.

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

25 drops contain 10 mg of zolpidem tartrate and correspond to 1 ml of solution.
Pour the required number of drops into a glass of water and drink it.
It is recommended to take Zolprem immediately before going to bed.

If you take more Zolprem than you should
In case of accidental ingestion/overdose of Zolprem, contact your doctor immediately or go to the nearest hospital.
In cases of overdose (overdosing) of Zolprem, either 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 Zolprem
Do not take a double dose to make up for the forgotten dose. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• are less pronounced if you take Zolprem immediately before going to bed or while already lying down,
• occur more frequently if you are elderly.

Common side effects (may affect up to 1 in 10 people):
drowsiness, headache, dizziness, increased 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, visual 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 certain body parts (paraesthesia),
• tremor,
• attention and speech disorders,
• confusion,
• irritability,
• restlessness,
• aggression,
• sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls or engaging in sexual activity) while not fully awake (see "Do not take Zolprem" 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 levels in certain 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,
• gait disturbances,
• falls (especially in elderly patients and when Zolpidem 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 Zolprem", "Warnings and precautions" and "How to take Zolprem")

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,
• delirium (a sudden and severe change in mental status causing a person to appear confused or disoriented),
• loss of response to the medicine (tolerance),
• swelling of the face, throat or limbs, possibly with breathing difficulty (angioneurotic oedema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may 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 Zolprem

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the bottle and outer carton after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage temperature.
• Store in the original packaging to protect the medicine from light.
• Discard the bottle 60 days after opening, even if some solution remains.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zolprem contains

• The active substance is zolpidem tartrate. Each ml (25 drops) contains 10 mg of zolpidem tartrate, equivalent to 8.03 mg of zolpidem.
• The other excipients are: citric acid monohydrate, sodium benzoate E211, purified water, sodium hydroxide (for pH adjustment), and concentrated hydrochloric acid 37% (for pH adjustment).

Description of the appearance of Zolprem and contents of the pack
Zolprem 10 mg/ml oral drops, solution, is a clear, colourless or slightly yellowish solution.
It is supplied in a bottle containing 30 ml of solution with a dropper for administration of the medicine.

Marketing Authorisation Holder and Manufacturer
Lifepharma S.p.A.
Via Dei Lavoratori, 54
20092 Cinisello Balsamo (Milan)
Italy
Marketing authorisation holder: POLIFARMA S.p.A. Viale dell’Arte 69, 00144 Rome, Italy

Manufacturer
Italfarmaco S.A.,
San Rafael, 3 Polig. Industrial Alcobendas
28108 Alcobendas (Madrid)
Spain

This medicinal product is authorised in the EEA Member States under the following names:
Italy: Zolprem 10 mg/ml oral drops, solution
February 2026