Sonirem

Package leaflet: Information for the user

SONIREM 10 mg/ml oral drops, solution

Zolpidem tartrate
Equivalent medicine
Please read all of 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. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Sonirem is and what it is used for

Sonirem contains zolpidem tartrate, which belongs to a class of medicines called "benzodiazepine-like drugs".
Sonirem is indicated for short-term treatment of sleep disorders (insomnia) in adults, only in cases where 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 Sonirem

Do not take Sonirem

• 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 breathing interruptions 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 Sonirem or other medicines containing zolpidem (see "Warnings and precautions").

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

Impairment of psychomotor function the following day (see also "Driving and use of machines")
Sonirem, like other medicines used to treat anxiety and/or insomnia, has central nervous system depressant effects.
The day after taking Sonirem, the risk of impaired psychomotor function, 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 medicines that increase zolpidem blood levels, or while consuming alcohol or illicit psychoactive substances.
  Take a 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 Sonirem may lead to the development of 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, substances, 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 duration of 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 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 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 (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 Sonirem treatment gradually.
It is important that you are aware of the possibility of such symptoms occurring, so that you can reduce your anxiety.

Duration of treatment:
The treatment duration should be as short as possible (see "How to take Sonirem") 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.
Initially, your doctor will explain that this treatment will be of limited duration and how you should gradually reduce the dose.

Memory disturbances (amnesia):
Sonirem 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" reactions:
During the use of benzodiazepines or medicines similar to Sonirem, the following may occur:

• restlessness,
• worsening of insomnia,
• agitation,
• irritability,
• aggression,
• delirium,
• anger,
• nightmares,
• hallucinations,
• mental disorders (psychosis),
• inappropriate behaviour.
  If these disturbances occur, contact your doctor and stop taking Sonirem. These reactions are more likely to occur in children and elderly patients.

Sleep disorders (sleepwalking) and associated behaviours:
Sonirem 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 Sonirem immediately and contact your doctor, as these sleep-related behaviours may seriously risk causing injury to yourself or others (see "Do not take Sonirem").
Both consuming alcohol or taking other sedative medicines together with Sonirem, and using Sonirem at doses exceeding the maximum recommended dose, increase the risk of these sleep-related behaviours occurring (see "Sonirem with alcohol" and "Possible side effects").

Severe injuries:
Sonirem may cause drowsiness and reduced consciousness, which may lead to falls and consequently to serious injuries.

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

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

Patients with psychotic disorders:
Sonirem is not recommended as primary treatment for psychotic disorders.

Patients with depression or anxiety associated with depression:
Sonirem should not be used alone to treat depression or anxiety associated with depression, as suicidal tendencies may increase.
Sonirem, 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 Sonirem. 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 if 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 substance abuse:
Sonirem 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
Sonirem must not be used in children and adolescents under 18 years of age (see "Do not take Sonirem").

Other medicines and Sonirem
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When taking Sonirem together with the following medicines, increased effects of drowsiness and impaired psychomotor function the following day may occur, including impaired ability to drive (see "Driving and use of machines"):

• medicines for certain mental health conditions (antipsychotics),
• medicines for sleep problems (hypnotics),
• medicines to calm or reduce anxiety,
• medicines for depression (antidepressants),
• medicines for moderate to severe pain (narcotic analgesics),
• medicines for epilepsy (anticonvulsants),
• medicines used for anaesthesia,
• medicines for hay fever, skin rashes (rash), or other allergies that may cause drowsiness (sedative antihistamines).
  While 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 Sonirem with fluvoxamine or ciprofloxacin.
The effects of Sonirem may also be influenced by, or may influence, the following medicines:

• highly effective painkillers (narcotic analgesics), as an increased sense of euphoria may occur, which could lead to increased 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 Sonirem;
• rifampicin (an antibiotic), as the effect of Sonirem decreases when taken with this medicine;
• St. John’s wort, as the effect of Sonirem decreases when taken with this herbal remedy;
• itraconazole (for fungal infections); the effect of Sonirem is not affected by this medicine;
• ketoconazole (for fungal infections), as concomitant administration of Sonirem and ketoconazole (200 mg twice daily) may increase the sedative effects of Sonirem.

Other medicines

• The use of Sonirem together with 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. Therefore, their combined use should only be considered when no other treatment options are available. However, if your doctor prescribes Sonirem 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 advice 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 such symptoms.
• No significant interactions have been observed when Sonirem is taken with warfarin (to reduce blood clotting), digoxin (for treatment of heart failure), or ranitidine (for stomach problems).

Sonirem with alcohol
Do not take Sonirem 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, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Sonirem must not be taken during pregnancy (see "Do not take Sonirem").
If you are pregnant, think you may be pregnant, or are planning a pregnancy, consult your doctor.
There is a risk that the baby may be affected if this medicine is used during pregnancy. Some studies have shown that the risk of cleft lip and palate (sometimes called "harelip") may increase in the newborn.
Reduced fetal movement and variability in fetal heart rate may occur after taking Sonirem during the second and/or third trimester of pregnancy.
If, for absolute medical necessity, Sonirem must be administered at the end of pregnancy or during delivery, the baby may show:

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

If this medicine is taken regularly during the final stages of pregnancy, the baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as restlessness or tremors. In such cases, the newborn must be closely monitored during the postnatal period.
Severe respiratory depression in the newborn may occur when Sonirem is used together with other medicines that depress the Central Nervous System at the end of pregnancy.

Breastfeeding
Sonirem passes into breast milk; therefore, it must not be taken during breastfeeding (see "Do not take Sonirem").

Driving and use of machines
Sonirem significantly impairs the ability to drive vehicles and operate machinery, for example, with the risk of "falling asleep at the wheel".
The day after taking Sonirem (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.

To minimize the above effects, a period of at least 8 hours is recommended between taking zolpidem and driving, operating machinery, or working at heights.
Do not drink alcohol or take other psychoactive substances while taking Sonirem, as these substances may increase the effects listed above.

Sonirem 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 Sonirem

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment should be as short as possible.
Generally, treatment lasts from a few days up to two weeks, with a maximum of four weeks including the phase of discontinuation of the medicine.
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 Sonirem per day. Do not exceed the dose of 10 mg (25 drops) every 24 hours.
To dispense the prescribed dose of 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 flow of medicine by turning the bottle back with the opening facing upwards. If the liquid does not come out of the bottle (small air or liquid bubbles may block the passage through the dropper), wait a few moments without shaking the bottle. To facilitate the flow of liquid, close the bottle, turn it upside down several times or tap it gently with a finger, and repeat the dispensing as described above.
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 Sonirem; the recommended dose is 5 mg (12–13 drops), 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 5 mg (12–13 drops), which should only be exceeded in exceptional cases.

Sonirem should be taken:

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

Ensure you allow at least 8 hours after taking this medicine before performing activities requiring your alertness.
Do not take another dose of Sonirem during the same night.

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

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 is recommended to take Sonirem just before going to bed.

If you take more Sonirem than you should
If you accidentally ingest/overdose on Sonirem, contact your doctor immediately or go to the nearest hospital.
In cases of overdose (overdosing) with Sonirem 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 Sonirem
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 Sonirem, dose-dependent side effects may occur, particularly affecting the
Central Nervous System (CNS).
These effects:

• are less pronounced if you take Sonirem 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,
• 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 certain parts of the body (paraesthesia),
• tremor,
• disturbances in attention and speech,
• confusion,
• irritability,
• restlessness,
• aggression,
• sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or having sexual intercourse) while not fully awake (see “Do not take Sonirem” 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,
• disturbances in gait,
• falls (especially in elderly patients and when Sonirem is not taken as prescribed) (see “Warnings and precautions”),
• urticaria,
• liver damage and bile flow impairment (hepatic hepatocellular, cholestatic, and mixed liver injury) (see “Do not take Sonirem”, “Warnings and precautions”, and “How to take Sonirem”).

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 state causing confusion or disorientation),
• loss of response to the medicine (tolerance),
• facial, throat, or limb swelling with possible breathing difficulty (angioedema).

Reporting of side effects
If you experience any side effect, 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 Sonirem

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the bottle and on the cardboard 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 medicines 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 Sonirem 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 Sonirem and contents of the pack
Sonirem 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
Marketing Authorisation Holder
Italfarmaco S.p.A.
Viale F. Testi, 330
20126 Milan
Italy
Manufacturer
Italfarmaco S.A.,
San Rafael, 3 Polig. Industrial Alcobendas
28108 Alcobendas (Madrid)
Spain

This medicinal product is authorised in EEA Member States under the following names:
Italy: Sonirem 10 mg/ml oral drops, solution
Greece: Oniria 10 mg/ml, πόσιμες σταγόνες διάλυμα
February 2026