Hipnogen

Package Leaflet: Information for the Patient

HYPNOGEN

10 mg, coated tablets

(Zolpidem tartrate)

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Hypnogen and what is it used for

Hypnogen is available in the form of coated tablets and contains the active substance zolpidem with a sedative and calming effect.
The medicine facilitates falling asleep, reduces the number of nighttime awakenings, prolongs sleep duration, and improves its quality.
Hypnogen is indicated for the short-term treatment of insomnia in adults in cases where insomnia causes weakness or significant exhaustion in the patient.
Do not take it for a long time. Treatment should last as short as possible, as the risk of dependence increases with the duration of treatment.

2. Important information before taking Hypnogen

Do not take Hypnogen in the following cases:

• hypersensitivity to zolpidem or any of the other ingredients of this medicine (listed in section 6),
• severe liver impairment,
• sleep apnea syndrome (short-term cessation of breathing),
• acute and/or severe respiratory failure,
• myasthenia gravis - a disease characterized by muscle weakness.

Warnings and precautions

Before starting to take Hypnogen, you should discuss it with your doctor or pharmacist.
In each case, you should determine, if possible, the causes of insomnia and, if possible, eliminate the factors that cause it, before the patient starts taking the sedative.
Persistence of insomnia after 7-14 days of treatment may indicate the existence of primary mental or physical disorders that require diagnosis and evaluation at regular intervals.
You should be particularly careful when taking Hypnogen:
in case of respiratory disorders, as sedatives can inhibit respiratory function (see section 4);
in case of mental illness - it is not recommended to take Hypnogen in the initial treatment of mental illnesses;
in case of depression, as these patients may experience suicidal thoughts and tendencies. If the patient has suicidal thoughts, they should contact their doctor as soon as possible to receive medical advice. The doctor should prescribe the smallest dose of the medicine to prevent intentional overdose. An increased frequency of suicides and suicide attempts has been shown in patients with depression who were treated with sedatives and hypnotics, including zolpidem, but a causal relationship for this observation has not been established.
During the use of Hypnogen, existing depression may be revealed. Since insomnia can be a symptom of depression, the patient should be re-examined by the doctor in case of persistent insomnia. Although no clinically significant interactions between zolpidem and selective serotonin reuptake inhibitors (see section: Hypnogen and other medicines) and other sedatives and hypnotics have been found, caution should be exercised when taking Hypnogen as well as other sedatives and hypnotics in patients with symptoms of depression;
in case of liver function disorders (the doctor may need to adjust the dose of the medicine - see below point 3). In patients with severe liver impairment, the use of zolpidem is contraindicated. The use of zolpidem in patients with severe liver impairment may lead to encephalopathy - a disorder of the central nervous system, as a result of the action of toxins appearing in the body due to liver damage (see section 2 above);
in case of elderly or weakened patients - in these patients, the doctor should adjust the dose of the medicine (see point 3).
Psychomotor disorders the next day(see also Driving and operating machinery)
Hypnogen has a sedative effect on the central nervous system.
The next day after taking Hypnogen, the risk of psychomotor disorders, including impaired ability to drive a vehicle, may be increased if:

• The patient took the medicine less than 8 hours before activities that require increased mental alertness
• The patient took a higher dose than the recommended dose
• The patient took zolpidem during treatment with other medicines that have a sedative effect on the central nervous system or other medicines that increase the concentration of zolpidem in the blood, while consuming alcohol or taking prohibited substances.

You should take a single dose directly before bedtime.
Do not take another dose on the same night.
Amnesia
Sedatives and hypnotics can cause subsequent amnesia. It usually occurs a few hours after taking the medicine. To reduce the risk, the patient should have the opportunity for uninterrupted sleep lasting 8 hours.
Other psychic reactions and "paradoxical"
The use of sedatives and hypnotics, including Hypnogen, may be accompanied by other psychic reactions and paradoxical reactions, such as: anxiety, increased insomnia, agitation, irritability, aggression, delusions, outbursts of anger, nightmares, hallucinations, inadequate behavior, and other behavioral disorders.
In such cases, treatment should be discontinued. The occurrence of such reactions is more likely in elderly patients.
Somnambulism and similar behaviors
In patients who took zolpidem and did not wake up completely, the following disorders may occur: sleepwalking and similar behavioral disorders, such as driving a vehicle while asleep, preparing and eating food, making phone calls, or having sexual intercourse while asleep, with no memory of the actions performed. It seems that consuming alcohol or taking other medicines with a depressive effect on the central nervous system, in combination with zolpidem, increases the risk of such behaviors, as well as taking zolpidem in doses exceeding the maximum recommended dose. In patients who report such behaviors, such as driving a vehicle while asleep, it is recommended to discontinue the use of Hypnogen, due to the risk to themselves and their surroundings (see section: Hypnogen and other medicinesand section 4 Possible side effects).
Tolerance
In the case of using Hypnogen for more than a few weeks, a decrease in its sedative effect may occur.
Dependence
Taking Hypnogen may lead to misuse of the medicine and/or the development of psychological or physical dependence.
The risk of dependence is higher when Hypnogen is used for more than 4 weeks and in patients with mental disorders and/or a history of alcohol, prohibited substances, or medicine abuse. If the patient has ever had mental disorders, abused, or been dependent on alcohol, prohibited substances, or medicines, they should tell their doctor.
In cases where physical dependence has developed, sudden discontinuation of treatment will be accompanied by withdrawal symptoms. These may include headaches and muscle pain, increased anxiety and tension, restlessness, confusion, and irritability. In severe cases, symptoms such as depersonalization, increased sensitivity to sound, light, and touch, hallucinations, and seizures may occur.
Rebound insomnia
After discontinuing the sedative, a transient syndrome may occur, in which the symptoms that led to the initiation of sedative treatment recur in an intensified form. These symptoms may be accompanied by other reactions, such as mood changes, anxiety, and fear.
It is essential to inform the patient about the possibility of rebound insomnia and take appropriate measures to minimize the risk of anxiety and other symptoms if they occur during the withdrawal of the medicine.
In the case of short-acting sedatives and hypnotics, the withdrawal syndrome may occur between doses.
Severe injuries
Due to its pharmacological properties, zolpidem can cause drowsiness and impaired consciousness, which may lead to falls and, consequently, severe injuries.
Patients with prolonged QT interval syndrome
The potential consequences of using zolpidem in patients with congenital prolonged QT interval syndrome are unknown. As a precaution, the doctor should carefully consider the benefit-risk ratio of zolpidem treatment in patients with diagnosed, congenital prolonged QT interval syndrome.
Children and adolescents
Hypnogen should not be used in children and adolescents under the age of 18, as the safety and efficacy of the medicine in this age group have not been established.

Hypnogen and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Alcohol
Concomitant use of alcohol is not recommended.
The sedative effect of zolpidem may be enhanced during concomitant alcohol consumption.
This may affect the ability to drive a vehicle and operate machinery.
Medicines with a sedative effect on the central nervous system:
When taking zolpidem with some medicines, the sedative effect may be enhanced, and the risk of psychomotor disorders the next day, including impaired ability to drive a vehicle, may increase. These medicines include:

• Medicines used to treat certain mental health disorders (antipsychotics)
• Medicines used to treat sleep disorders (sedatives)
• Medicines that calm or reduce anxiety
• Medicines used to treat depression
• Medicines used to treat moderate to severe pain (opioid analgesics)
• Medicines used to treat epilepsy
• Medicines used in anesthesia
• Medicines used to treat hay fever, rash, or other allergies that may cause drowsiness in the patient (sedating antihistamines)

When taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may experience visual hallucinations.
Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.
Concomitant use of Hypnogen and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and may be fatal. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
However, when the doctor prescribes Hypnogen together with opioids, the dose and duration of concomitant use should be limited by the doctor.
You should inform your doctor about all opioid medicines you are taking and strictly follow the dosage instructions. It may be helpful to inform your friends and family members to be aware of the above-mentioned signs and symptoms.
In case of their occurrence, you should contact your doctor.
Cytochrome P450 inhibitors and inducers
Certain medicines that inhibit liver enzymes (especially cytochrome P450) may enhance the effect of certain sedatives, such as Hypnogen.
Concomitant use of CYP3A4 inducers, such as rifampicin and St. John's Wort, reduces the pharmacodynamic effect of zolpidem.
When taking St. John's Wort, the concentration of zolpidem in the blood may decrease. Concomitant use of Hypnogen with St. John's Wort is not recommended.
Concomitant use of Hypnogen with ketoconazole (200 mg twice a day) may enhance its sedative effect.
Other medicines
No significant pharmacokinetic interactions have been observed when zolpidem is taken with warfarin, digoxin, and ranitidine.

Hypnogen with food and drink

The medicine should be taken directly before bedtime or after lying down.
Do not drink alcohol while taking Hypnogen, as alcohol may enhance the sedative effect of the medicine.

Pregnancy and breastfeeding

Pregnancy
Hypnogen should not be used in pregnant women. If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
The medicine used during pregnancy may affect the fetus. Some studies have shown an increased risk of cleft lip and palate (sometimes called "harelip") in newborns.
Decreased fetal movement and variable fetal heart rate may occur if the mother takes Hypnogen in the second and/or third trimester of pregnancy.
If the patient takes Hypnogen in late pregnancy or during childbirth, her child may experience muscle weakness, decreased body temperature, feeding difficulties, and respiratory disorders (respiratory depression).
If the patient regularly takes Hypnogen in late pregnancy, her child may develop physical dependence, and withdrawal symptoms, such as agitation or seizures, may occur.
In such cases, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Hypnogen should not be used during breastfeeding, as a small amount of the medicine passes into breast milk.

Driving and operating machinery

Hypnogen has a significant impact on the ability to drive a vehicle and operate machinery and may cause events such as "falling asleep at the wheel". The next day after taking Hypnogen (like other sedatives), it may happen that:

• the patient feels drowsy, sleepy, dizzy, or disoriented,
• the patient needs more time to make quick decisions (impaired reflex),
• the patient may see blurry or double vision,
• the patient may be less alert.

In order to minimize the risk of the above-mentioned events, it is recommended to maintain at least an 8-hour interval between taking Hypnogen and driving a vehicle, operating machinery, and working at heights.
Do not consume alcohol or psychoactive substances while taking Hypnogen, as this may enhance the above-mentioned effects.

Hypnogen contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Hypnogen

This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult your doctor or pharmacist.
The medicine should be taken orally.
Hypnogen acts quickly, so you should take it directly before bedtime or after lying down.
As with all sedatives, it is not recommended to take Hypnogen for a long time. The recommended treatment duration should not exceed 4 weeks.
In some cases, it may be necessary to extend the treatment period by the doctor beyond the maximum recommended time, but this should not be done without re-evaluating the patient's clinical condition by the doctor.
Adults
The recommended dose of Hypnogen is 10 mg (1 tablet) per 24 hours. Some patients may be prescribed a lower dose by their doctor. Hypnogen should be taken:

• in a single dose,
• directly before bedtime.

The patient must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased concentration.
Do not exceed the dose of 10 mg per 24 hours.
Elderly patients (over 65 years) or weakened patients
In elderly or weakened patients who may be particularly sensitive to zolpidem, a dose of 5 mg of Hypnogen (half a tablet) is recommended. In this group of patients, the daily dose should not exceed 10 mg.
Patients with liver function disorders
In patients with liver function disorders, due to reduced clearance and metabolism of zolpidem, the doctor will reduce the initial dose to 5 mg, while exercising particular caution, especially in elderly patients.
In adults (under 65 years), it is possible to increase the dose to 10 mg by the doctor if the patient's condition is good and the medicine is well tolerated, but only in cases where the effect of the medicine is insufficient.
Children and adolescents
Hypnogen should not be used in children and adolescents under the age of 18 (see section 2).
The safety and efficacy of the medicine in this age group have not been established.
If you feel that the effect of Hypnogen is too strong or too weak, you should consult your doctor.

Taking a higher dose of Hypnogen than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult your doctor.
In cases of zolpidem overdose, either alone or in combination with other medicines that have a depressive effect on the central nervous system (including alcohol consumption), impaired consciousness of varying degrees has been observed - from increased drowsiness to coma, as well as more severe symptoms, including fatal cases.
After an overdose of zolpidem, symptomatic and supportive treatment is recommended; gastric lavage or activated charcoal may be performed to reduce the absorption of the medicine from the gastrointestinal tract.
Sedatives should be discontinued, even in cases of agitation.
In cases of severe symptoms, the doctor will consider administering flumazenil. However, the use of flumazenil may cause neurological symptoms (seizures).
Zolpidem is not eliminated from the body by hemodialysis.

Missing a dose of Hypnogen

Do not take a double dose to make up for a missed dose.
In case of a missed dose, you should take the medicine the next day at the usual time.

Discontinuing Hypnogen

Do not stop taking Hypnogen abruptly, as this increases the risk of withdrawal symptoms. The doctor will inform the patient about how to stop the treatment by gradually reducing the dose.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hypnogen can cause side effects, although not everybody gets them.
There is evidence that side effects related to the use of zolpidem, especially side effects related to the central nervous system, depend on the dose of the medicine. Side effects are less severe if the medicine is taken directly before bedtime or after lying down (see section 3). They are most commonly observed in elderly patients.
The following side effects are possible, with an indication of their frequency:

Frequent (may occur in up to 1 in 10 people):
drowsiness, headache, dizziness, increased insomnia, subsequent amnesia (may be associated with unusual behavior), hallucinations, agitation, nightmares, depression, fatigue, diarrhea, nausea, vomiting, abdominal pain, infections of the upper and lower respiratory tract, back pain.
Infrequent (may occur in up to 1 in 100 people):
confusion, irritability, anxiety, aggression, somnambulism (see section 2), euphoria, double vision, paresthesia (tingling, prickling), tremor, attention disorders, speech disorders, blurred vision, increased liver enzyme activity, rash, itching, excessive sweating, appetite disorders, joint pain, muscle pain, muscle cramps, neck pain, muscle weakness.
Rare (may occur in up to 1 in 1,000 people):
libido disorders (sexual desire), consciousness disorders, liver damage caused by the toxic effect of the medicine, hives, vision disorders, gait disorders, falls (especially in elderly patients and when the medicine is not taken as recommended) - see section 2.
Very rare (may occur in up to 1 in 10,000 people):
delusions, dependence (after stopping treatment, withdrawal symptoms or rebound effect may occur), respiratory depression (breathing difficulties - see section 2).
Frequency not known (frequency cannot be estimated from the available data):
anger, behavioral disorders (most psychiatric side effects are related to paradoxical reactions), angioedema (a severe allergic reaction - edema may affect the face, limbs, mouth, throat, and cause breathing difficulties), tolerance to the medicine.
In case of the following side effects, which are more likely to occur in elderly patients, you should immediately stop taking the medicine: anxiety (especially motor), increased insomnia, agitation, irritability, aggression, delusions, fury, nightmares, hallucinations, inadequate behavior, somnambulism, and other behavioral disorders.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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,
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Hypnogen

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hypnogen contains

• The active substance of the medicine is zolpidem. One coated tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose 2910/6, magnesium stearate, titanium dioxide (E171), macrogol 300, simethicone emulsion SE4.

What Hypnogen looks like and contents of the pack

White or almost white coated tablets with a score line on one side to facilitate breaking.
Pack sizes: 7, 15, 20, 30, or 100 coated tablets.

Marketing authorization holder and manufacturer:

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
To obtain more detailed information, you should contact the representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

Date of last revision of the leaflet: