Sanval

Package Leaflet: Information for the Patient

Sanval, 10 mg, Film-Coated Tablets

Zolpidem Tartrate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What Sanval is and What it is Used For
• 2. Important Information Before Taking Sanval
• 3. How to Take Sanval
• 4. Possible Side Effects
• 5. How to Store Sanval
• 6. Contents of the Package and Other Information

1. What Sanval is and What it is Used For

Sanval is a sleeping pill that contains zolpidem tartrate as the active substance. The medication accelerates falling asleep, reduces the number of awakenings, prolongs sleep duration, and improves its quality.
Sanval is used for short-term treatment of insomnia in adults.

2. Important Information Before Taking Sanval

When Not to Take Sanval

if the patient is allergic to zolpidem or any of the other ingredients of this medication (listed in section 6);
if the patient has been diagnosed with sleep apnea syndrome;
if the patient suffers from myasthenia gravis;
if the patient has severe liver impairment;
if the patient has acute and/or severe respiratory failure;
if the patient has been diagnosed with poisoning with neuroleptic or antidepressant medications;
if the patient has a history of complex behaviors during sleep after taking zolpidem;
in children and adolescents under 18 years of age.

Warnings and Precautions

Before starting treatment with Sanval, the patient should discuss it with their doctor or pharmacist.
If possible, before prescribing a sleeping pill, the doctor should, based on the patient's medical history and examination, determine the cause of insomnia and, if possible, help the patient eliminate it.
Sanval may exacerbate symptoms of certain diseases.
Before taking the medication, the patient should inform their doctor about any current or past:
depression,
abuse or dependence on medications, drugs, or alcohol,
psychotic disorders,
liver diseases.
Taking the medication may cause falls and, consequently, severe injuries.
Elderly and weakened patients should strictly follow the recommended dosage.
Due to the increased risk of falls and fractures, as well as severe injuries, elderly patients should be cautious, especially when getting up at night.
Psychomotor Disorders the Next Day (see also "Driving and Operating Machinery")
The day after taking Sanval, the risk of psychomotor disorders, including impaired driving ability, may be increased if:
the patient took the medication less than 8 hours before activities that require increased alertness;
the patient took a higher dose than recommended;
the patient took zolpidem while being treated with other medications that have a sedative effect on the central nervous system or other medications that increase the concentration of zolpidem in the blood, while consuming alcohol or taking prohibited substances - see "Sanval and Other Medications".
The patient should take a single dose directly before bedtime.
The patient should not take another dose on the same night.
Before starting treatment with Sanval, the patient should pay attention to the following information:
Zolpidem (the active substance of Sanval) has a sedative effect on the central nervous system.
Frequent use of Sanval for several weeks may reduce the medication's effectiveness (the so-called tolerance phenomenon).
In patients taking such medications as Sanval and not fully awake, there have been reports of complex behaviors during sleep, including somnambulism (sleepwalking) and other behaviors, such as sleeping while driving, preparing and eating meals, making phone calls, or having sex, without being aware of the event. If the patient experiences complex behaviors during sleep, the doctor will recommend stopping the treatment due to the risk it may pose to both the patient and their surroundings. Taking higher-than-recommended doses of the medication, as well as drinking alcohol during treatment and/or taking other substances that have a sedative effect on the nervous system, may increase the risk of such behaviors.
Sanval, like other medications in this group, may cause physical and/or psychological dependence, especially with long-term use. The risk of dependence increases in proportion to the dose and duration of treatment. The risk of abuse and dependence is also higher in patients with current or past mental disorders, alcohol, drug, or medication abuse. Patients from this group should be under close medical supervision during treatment with Sanval. If dependence occurs, sudden cessation of Sanval may cause withdrawal syndrome (see section 3 "Stopping Sanval"). There have been reports of withdrawal syndrome occurring between doses, especially when the patient has taken large doses.
After stopping the medication, the patient may experience so-called rebound insomnia, which is an exacerbation of symptoms for which the doctor prescribed a sedative. Along with insomnia, mood changes, anxiety, and restlessness may occur.
Taking Sanval may cause anterograde amnesia, which is a transient inability to remember current events. After taking the medication, the patient should have at least 8 hours of uninterrupted sleep.
In patients taking sedatives, the following reactions may occur:
anxiety, increased insomnia, agitation, irritability, aggression, delusions, fits of anger, nightmares, hallucinations, psychosis, abnormal behavior, and other behavioral disorders.
In such cases, the patient should stop taking the medication and immediately consult their doctor.
These reactions occur more frequently in elderly patients.
Concomitant use of Sanval and opioid pain medications (strong painkillers and some cough medications) may cause excessive sedation, respiratory failure, coma, and death. When taking such medications together, the patient should strictly follow the doctor's recommendations regarding dosage and treatment duration. The doctor will inform the patient about the risk and will closely monitor whether the patient experiences symptoms of respiratory disorders and excessive sedation. If these symptoms occur, the patient should contact their doctor. It may be helpful to inform friends or family members about the risk of these symptoms. If they occur, the patient should contact their doctor.
In patients with depression and without depression, taking benzodiazepines (medications used to treat insomnia and anxiety disorders) or other sleeping pills, including zolpidem, has been associated with an increased frequency of suicidal thoughts and attempts. However, a link with zolpidem has not been established. If the patient has suicidal thoughts, they should contact their doctor as soon as possible to receive medical advice.
During treatment with zolpidem, pre-existing depression may be revealed. Since insomnia can be a symptom of depression, if insomnia persists, the doctor should re-examine the patient.

Sanval with Food, Drink, and Alcohol

The medication should be taken directly before bedtime. The tablet should be swallowed whole, without chewing, with a liquid.
During treatment, the patient should not drink alcohol, as it may enhance the sedative effect of Sanval.
During treatment with Sanval, the patient should not drink grapefruit juice, as it may increase the effect of the medication.

Sanval and Other Medications

The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as medications they plan to take.
When taking zolpidem with certain medications, sedation and psychomotor disorders the next day, including impaired driving ability, may be increased.
These medications include:
medications used to treat certain mental health disorders (antipsychotics)
medications used to treat sleep problems (sleeping pills)
medications that have a sedative or anxiolytic effect
medications used to treat depression
medications used to treat moderate to severe pain (narcotic painkillers)
medications used to treat epilepsy
medications used in anesthesia
medications used to treat allergies, which may cause drowsiness in the patient (sedating antihistamines)
certain antifungal medications
macrolide antibiotics.
When taking zolpidem with antidepressant medications (including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine), the patient may experience visual hallucinations.
It is not recommended to take zolpidem with fluvoxamine, ciprofloxacin, rifampicin, carbamazepine, and medications containing St. John's Wort.
Concomitant use of opioid pain medications may increase the risk of psychological dependence.
Concomitant use of ketokonazole may increase the sedative effect of Sanval.
Concomitant use of Sanval and medications that affect brain function (i.e., other sedatives, such as benzodiazepines or similar medications) increases the risk of sedation, respiratory difficulties, coma, and may be life-threatening. Therefore, the doctor will consider concomitant use only when other treatment methods are not possible.
If the doctor prescribes Sanval together with other sedatives, they will use a limited dose and limited treatment duration. The patient should tell their doctor about all sedatives they are taking and strictly follow the recommended dosage.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medication.
Pregnancy
It is not recommended to take the medication during pregnancy due to the risk of harm to the fetus.
Some studies have shown a higher frequency of cleft lip and palate, reduced fetal movement, and variable heart rate. In newborns of mothers who took the medication in late pregnancy or during delivery, side effects such as decreased body temperature, reduced muscle tone ("floppy infant syndrome"), and respiratory failure may occur. In children born to mothers who took the medication for a long time in late pregnancy, physical dependence and withdrawal syndrome may occur.
Breastfeeding
The medication should not be taken by breastfeeding women, as it passes into breast milk.
Fertility
There is no available data on the effect of the medication on fertility.

Driving and Operating Machinery

Sanval has a major impact on the ability to drive and operate machinery and may cause events such as "falling asleep at the wheel". The day after taking Sanval (like other sleeping pills), the patient may:

• feel drowsy, sleepy, have dizziness or be disoriented,
• need more time to make quick decisions (impaired reflexes),
• have blurred or double vision,
• be less alert.

To minimize the risk of these events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, or working at heights.
The patient should not consume alcohol or psychoactive substances while taking Sanval, as this may increase the above-mentioned effects.

Sanval Contains Lactose and Sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medication.
This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free".

3. How to Take Sanval

This medication should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Dosage for Adults
The recommended dose of Sanval is 10 mg per 24 hours. The doctor may prescribe a lower dose for some patients.
Sanval should be taken:

• in a single dose,
• directly before bedtime.

The patient must maintain at least an 8-hour interval between taking the medication and starting activities that require increased concentration.
The patient should not exceed the dose of 10 mg per 24 hours.
Dosage for Elderly and Weakened Patients
The recommended daily dose is 5 mg, due to possible increased sensitivity to the medication.
The patient should not exceed the recommended doses.
Dosage for Patients with Liver Function Disorders
Treatment should be started with a dose of 5 mg per day, due to slower elimination of zolpidem from the body. Particular caution should be exercised in elderly patients. In patients over 65 years of age, the doctor may increase the initial dose of Sanval to 10 mg per day only if the lower dose is ineffective and the patient tolerates the medication well.
Method of Administration and Treatment Duration
Zolpidem acts very quickly, so Sanval should be taken directly before bedtime.
The tablet should be swallowed whole, without chewing, with a liquid.
As with all sleeping pills, long-term use of Sanval is not recommended.
The recommended treatment duration is from a few days to two weeks.
Treatment should not exceed 4 weeks. Persistent insomnia after 14 days of treatment may indicate the presence of underlying mental or physical disorders that are the cause of insomnia, so the doctor should regularly monitor the treatment.
Children and Adolescents
Sanval should not be taken by children and adolescents under 18 years of age.
If the patient feels that the effect of Sanval is too strong or too weak, they should consult their doctor.

Taking a Higher-than-Recommended Dose of Sanval

In case of taking a higher-than-recommended dose of the medication, the patient should immediately consult their doctor or go to the emergency department.
Symptoms
Depending on the dose taken, poisoning with medications like Sanval usually causes inhibition of the central nervous system (from drowsiness, lethargy, and confusion to loss of consciousness, respiratory and cardiac arrest, and coma), with a risk of death. Visual disturbances, slurred speech, dystonia (a neurological disorder that causes involuntary, unnatural movements), ataxia, muscle weakness, restlessness, and hallucinations are also possible.
Procedure
In case of overdose, the doctor will provide symptomatic and supportive treatment.
Patients with mild symptoms of poisoning should be allowed to sleep under close monitoring of breathing and circulation. In most severe cases, gastric lavage, administration of activated charcoal, intravenous fluids, and treatment in an intensive care unit may be necessary. Sedatives should not be administered, even if the patient is agitated.
The medication is not removed from the body during dialysis.

Missing a Dose of Sanval

The patient should not take a double dose to make up for a missed dose.

Stopping Sanval

Sudden cessation of treatment may cause withdrawal syndrome with the following symptoms: headaches and muscle pain, extreme anxiety and tension, restlessness, confusion, and irritability. In severe cases, the following may occur: derealization (a feeling that the surrounding world is not real), depersonalization (loss of sense of one's own identity), hyperacusis, paresthesia, hypersensitivity to light, sounds, and touch, hallucinations, and seizures.
The doctor will inform the patient about how to stop the treatment by gradually reducing the dose.

4. Possible Side Effects

Like all medications, Sanval can cause side effects, although not everyone will experience them.
Side effects occur more frequently in elderly patients. There is also a relationship between the dose of Sanval and the occurrence of side effects.
Common Side Effects(may occur in less than 1 in 10 people):
upper respiratory tract infections, lower respiratory tract infections, hallucinations, agitation, nightmares, depression, drowsiness, headache, dizziness, increased insomnia, cognitive disorders, such as anterograde amnesia (memory disorders may be accompanied by behavioral disorders), diarrhea, nausea, vomiting, abdominal pain, back pain, fatigue.
Uncommon Side Effects(may occur in less than 1 in 100 people):
changes in appetite, confusion, irritability, restlessness (mainly motor), aggression, somnambulism, complex behaviors during sleep, euphoric mood, paresthesia, tremors, attention disorders, speech disorders, blurred vision, double vision, increased liver enzyme activity, rash, itching, excessive sweating, joint pain, muscle pain, muscle spasms, neck pain, muscle weakness, pallor, orthostatic hypotension, decreased cognitive abilities, concentration disorders, emotional instability, migraine, stupor, difficulty swallowing, bloating with gas, hiccups, gastritis, cerebral circulation disorders, hypertension, tachycardia, hyperglycemia, arthritis, menstrual disorders, vaginitis, bronchitis, cough, dyspnea, cystitis, urinary incontinence, malaise, edema, injury, fever.
Rare Side Effects(may occur in less than 1 in 1,000 people):
changes in libido, changes in consciousness, visual disturbances, liver damage related to liver cells, cholestatic or mixed, urticaria, gait disorders, falls (mainly in elderly patients, as well as when the medication is not taken as recommended).
Very Rare Side Effects(may occur in less than 1 in 10,000 people):
delusions, dependence (after stopping treatment, withdrawal symptoms or "rebound" symptoms may occur), respiratory failure.
Side Effects with Unknown Frequency(frequency cannot be estimated from available data):
angioedema (Quincke's edema), outbursts of anger, psychosis, abnormal behavior, development of tolerance (reduced effectiveness).
Treatment with zolpidem may reveal pre-existing depression. Since insomnia can be a symptom of depression, if insomnia persists, the patient should be re-examined by their doctor.
Reporting Side Effects
If any side effects occur, including those not listed in this package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder
By reporting side effects, it is possible to gather more information on the safety of the medication.

5. How to Store Sanval

The medication should be stored out of sight and reach of children.
Store in a temperature below 25°C.
The medication should not be taken after the expiration date stated on the packaging after EXP.
The expiration date refers to the last day of the specified month.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Sanval Contains

The active substance is zolpidem tartrate.
One tablet contains 10 mg of zolpidem tartrate.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, povidone, colloidal silica, magnesium stearate.
The tablet coating contains: hypromellose, hydroxypropylcellulose, macrogol 400, talc, titanium dioxide, carnauba wax.

What Sanval Looks Like and What the Package Contains

Sanval is a film-coated tablet. It is available in blisters of aluminum/PVC film, in a cardboard box, containing 10 or 20 tablets.

Marketing Authorization Holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava, Slovenia
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain more detailed information, the patient should contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of Last Revision of the Package Leaflet:05/2025
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