HYPNOGEN

Patient Information Leaflet

HYPNOGEN
10 mg, coated tablets
(Zolpidemi tartras)
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Hypnogen is and what it is 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 Hypnogen is and what it is used for

Hypnogen is available as coated tablets and contains the active substance zolpidem, which has hypnotic and sedative properties.
The medicine facilitates falling asleep, reduces the number of nocturnal awakenings, prolongs sleep duration, and improves sleep quality.
Hypnogen is indicated for short-term treatment of insomnia in adults when insomnia causes significant distress or impairment.
Do not use for prolonged periods. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.

2. Important information before taking Hypnogen

Do not take Hypnogen if:

• you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6),
• you have severe liver impairment,
• you have sleep apnoea syndrome (briefly stopping breathing during sleep),
• acute and/or severe respiratory insufficiency,
• myasthenia gravis (a disease characterised by muscle weakness).

Warnings and precautions
Before starting to take Hypnogen, you should discuss this with your doctor or pharmacist.
The underlying causes of insomnia should be identified, if possible, and contributing factors eliminated before initiating treatment with a hypnotic medicine.
Persistent insomnia after 7–14 days of treatment may indicate the presence of underlying psychological or physical disorders requiring diagnosis and regular assessment.
Special caution is required when taking Hypnogen:

• in case of respiratory disorders, as hypnotic medicines may depress respiratory function (see section 4);
• in case of psychiatric disorders – Hypnogen is not recommended for initial treatment of psychiatric conditions;
• in case of depression, as suicidal thoughts and tendencies may occur in these patients. If a patient experiences suicidal thoughts, they should contact their doctor immediately for medical advice. The doctor should prescribe the lowest effective dose to minimise the risk of intentional overdose. An increased incidence of suicide and suicide attempts has been observed in depressed patients treated with sedative and hypnotic medicines, including zolpidem, although a causal relationship has not been established.
  Insomnia may be a symptom of depression. Since depression may emerge during treatment with Hypnogen, patients with persistent insomnia should be reassessed by a doctor. Although no clinically significant interactions between zolpidem and selective serotonin reuptake inhibitors (see section: Hypnogen with other medicines) or other sedative and hypnotic medicines have been demonstrated, caution should be exercised when using Hypnogen and other sedative or hypnotic medicines in patients with depressive symptoms;
• in case of liver dysfunction (the doctor may need to adjust the dose – see section 3 below). Hypnogen is contraindicated in patients with severe hepatic impairment. Use of zolpidem in patients with severe liver impairment may lead to encephalopathy – a disturbance of central nervous system function due to toxins accumulating in the body as a result of liver damage (see section 2 above);
• in elderly or debilitated patients – the doctor should adjust the dose in these patients (see section 3).

Next-day psychomotor impairment (see also Driving and operating machinery)
Hypnogen has a central nervous system depressant effect.
The risk of next-day psychomotor impairment, including impaired ability to drive, may be increased if:

• the medicine is taken less than 8 hours before activities requiring full alertness,
• a higher than recommended dose is taken,
• zolpidem is taken together with other medicines that depress the central nervous system or other medicines that increase zolpidem blood levels, during alcohol consumption, or when using illicit substances.

A single dose should be taken immediately before bedtime.
Do not take another dose during the same night.

Amnesia
Sedative and hypnotic medicines may cause anterograde amnesia. This most commonly occurs several hours after taking the medicine. To reduce the risk, patients should ensure they are able to have uninterrupted sleep for 8 hours.

Other psychiatric and "paradoxical" reactions
Sedative and hypnotic medicines, including Hypnogen, may be associated with other psychiatric and paradoxical reactions such as anxiety, worsened insomnia, agitation, irritability, aggression, hallucinations, anger outbursts, nightmares, hallucinations, inappropriate behaviour and other behavioural disturbances.
If such reactions occur, treatment should be discontinued. These reactions are more likely to occur in elderly patients.

Sleepwalking and similar behaviours
In patients taking zolpidem who do not fully awaken, the following disturbances may occur: sleepwalking and similar behavioural disturbances, such as driving while asleep, preparing and eating food, making phone calls, or engaging in sexual activity while asleep, with no memory of these actions. Alcohol consumption or concomitant use of other central nervous system depressants with zolpidem appears to increase the risk of such behaviours, as does using zolpidem at doses exceeding the maximum recommended dose. Patients reporting such behaviours, such as sleep-driving, should discontinue Hypnogen due to the risk to themselves and others (see section: Hypnogen with other medicines and section 4. Possible side effects).

Tolerance
When Hypnogen is used for longer than a few weeks, its hypnotic effect may decrease.

Dependence
Use of Hypnogen may lead to drug abuse and/or development of psychological or physical dependence.
The risk of dependence is higher when Hypnogen is used for longer than 4 weeks and in patients with psychiatric disorders and/or a history of alcohol, illicit substance, or drug abuse. Patients who have ever had psychiatric disorders or abused or been dependent on alcohol, illicit substances, or drugs should inform their doctor.
In cases of physical dependence, abrupt discontinuation of treatment may lead to withdrawal symptoms. These may include headache and muscle pain, increased anxiety and tension, restlessness, confusion, and irritability. In severe cases, symptoms such as depersonalisation, derealisation, heightened auditory sensitivity, numbness and tingling of extremities, hypersensitivity to light, noise, and touch, hallucinations, and seizures may occur.

Rebound insomnia (rebound insomnia)
After stopping hypnotic treatment, a transient syndrome may occur in which the symptoms that led to sedative and hypnotic treatment return in an intensified form. These symptoms may be accompanied by other reactions such as mood changes, restlessness, and anxiety.
It is important to inform the patient about the possibility of rebound insomnia and to take appropriate measures to minimise the risk of anxiety and other symptoms during discontinuation.
With short-acting sedative and hypnotic medicines, withdrawal symptoms may occur between doses.

Severe injuries
Due to its pharmacological properties, zolpidem may cause drowsiness and disturbances in consciousness, which may lead to falls and consequently to severe injuries.

Patients with prolonged QT interval syndrome
The potential consequences of using zolpidem in patients with congenital long QT syndrome are unknown. As a precaution, the doctor should carefully weigh the benefits against the risks of zolpidem treatment in patients diagnosed with congenital long QT syndrome.

Children and adolescents
Hypnogen should not be used in children and adolescents under 18 years of age, as safety and efficacy have not been established in this age group.

Hypnogen with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Alcohol
Concomitant use of alcohol is not recommended.
Alcohol may enhance the sedative effect of zolpidem.
This may affect your ability to drive and operate machinery.

Medicines with central nervous system depressant effects:
When zolpidem is used with certain medicines, drowsiness and next-day psychomotor impairment, including impaired driving ability, may be intensified. These include:

• Medicines used to treat certain mental health disorders (antipsychotics)
• Medicines used to treat sleep problems (hypnotics)
• Sedatives or anxiolytics
• Medicines used to treat depression
• Medicines used to treat moderate to severe pain (opioid analgesics)
• Medicines used to treat epilepsy
• Medicines used in anaesthesia
• Medicines used to treat hay fever, rashes, or other allergies that may cause drowsiness (sedating antihistamines)

When zolpidem is taken with antidepressants such as bupropion, desipramine, fluoxetine, sertraline, or venlafaxine, patients may see things that are not real (visual hallucinations).
Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.
Concomitant use of Hypnogen and opioids (strong painkillers, drugs used in substitution treatment, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use of these medicines should only be considered when no other treatment options are available.
However, if your doctor prescribes Hypnogen together with opioids, the dose and duration of concomitant use should be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and strictly follow dosing instructions. It may be helpful to inform your friends and family to be aware of the symptoms mentioned above.
If these symptoms occur, contact your doctor immediately.

Inhibitors and inducers of cytochrome P450
Some medicines that inhibit liver enzymes (especially cytochrome P450) may enhance the effects of certain hypnotic medicines such as Hypnogen.
Concomitant use of CYP3A4 inducers such as rifampicin and St John's wort (Hypericum perforatum) reduces the pharmacodynamic effect of zolpidem.
Concomitant use of St John's wort may reduce zolpidem blood levels. Concomitant use of Hypnogen with St John's wort is not recommended.
Concomitant use of Hypnogen with ketoconazole (200 mg twice daily) may enhance its sedative effect.

Other medicines
No significant pharmacokinetic interactions were observed when zolpidem was used concomitantly with warfarin, digoxin, or ranitidine.

Hypnogen with food and drink
Take the medicine immediately before going to bed or after lying down.
Do not drink alcohol while taking Hypnogen, as alcohol may intensify the sedative effect of the medicine.

Pregnancy and breastfeeding
Pregnancy
Hypnogen should not be used during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning to have a child, you should consult your doctor before using this medicine.
Use of this medicine during pregnancy may affect the unborn child. Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.
Reduced fetal movement and variable fetal heart rate may occur if the mother uses Hypnogen during the second and/or third trimester of pregnancy.
If you take Hypnogen late in pregnancy or during labour, your baby may have muscle weakness, low body temperature, feeding difficulties, and breathing problems (respiratory depression).
If you regularly take Hypnogen late in pregnancy, your baby 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.

Breast-feeding
Do not take Hypnogen while breast-feeding, as small amounts of the medicine pass into breast milk.

Driving and operating machinery
Hypnogen has a major influence on the ability to drive and operate machinery and may cause events such as "falling asleep at the wheel". The day after taking Hypnogen (as with other hypnotic medicines), you may:

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

To minimise the risk of these events, it is recommended to wait at least 8 hours between taking Hypnogen and driving, operating machinery, or working at heights.
Do not consume alcohol or psychoactive substances while taking Hypnogen, as this may intensify the effects mentioned above.

Hypnogen contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to use Hypnogen

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
This medicine should be taken by mouth.
Hypnogen acts rapidly, therefore it should be taken immediately before going to bed or after lying down.
As with all sleep medicines, prolonged use of Hypnogen is not recommended. The recommended duration of treatment should not exceed 4 weeks.
In some cases, your doctor may need to extend the treatment period beyond the maximum recommended duration; however, this must not be done without a re-evaluation of the patient's clinical condition by the doctor.

Adults
The recommended dose of Hypnogen is 10 mg (1 tablet) once daily. Your doctor may prescribe a lower dose for some patients. Hypnogen should be taken:

• as a single dose,
• immediately before sleep.

Patients must ensure an interval of at least 8 hours between taking the medicine and engaging in activities requiring increased concentration.
Do not exceed the dose of 10 mg in 24 hours.

Elderly patients (over 65 years of age) or debilitated patients
In elderly or debilitated patients, who may be particularly sensitive to zolpidem, a dose of 5 mg of Hypnogen (half a tablet) is recommended. In this patient group, the daily dose must not exceed 10 mg.

Patients with hepatic impairment
In patients with impaired liver function, due to reduced clearance and metabolism of zolpidem, your doctor will reduce the initial dose to 5 mg, exercising particular caution, especially in elderly patients.
In adults (under 65 years of age), the dose may be increased by the doctor to 10 mg if the patient's condition is good and the medicine is well tolerated, and only if the therapeutic effect is insufficient.

Children and adolescents
Hypnogen must not be used in children and adolescents under 18 years of age (see section 2).
The safety and efficacy of use in this age group have not been established.

If you feel the effect of Hypnogen is too strong or too weak, consult your doctor.

Taking more Hypnogen than recommended
If you take more Hypnogen than you should, contact your doctor immediately.
Overdose with zolpidem alone or in combination with other central nervous system depressants (including alcohol) has been associated with disturbances of consciousness ranging from excessive drowsiness to coma, and more severe symptoms, including fatal cases.
After zolpidem overdose, symptomatic and supportive treatment is recommended; gastric lavage or activated charcoal may be administered to reduce drug absorption from the gastrointestinal tract.
Sedatives should be discontinued, even in the presence of agitation.
In cases of severe symptoms, the doctor may consider administering flumazenil. However, flumazenil administration may provoke neurological symptoms (seizures).
Zolpidem is not effectively removed by hemodialysis.

If you forget to take Hypnogen
Do not take a double dose to make up for a missed dose.
If you miss a dose, take the medicine the next day at the usual time.

Stopping Hypnogen
Do not stop taking Hypnogen suddenly, as this increases the risk of withdrawal symptoms. Your doctor will advise you on how to discontinue treatment gradually by tapering the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
There is evidence that adverse reactions associated with zolpidem use, particularly those affecting the
central nervous system, are dose-dependent. Adverse reactions are less pronounced when the medicine
is taken immediately before going to bed or after lying down (see section 3). They are most commonly
observed in elderly patients.
The possible adverse reactions listed below are categorized according to their frequency of occurrence:
Common (may affect up to 1 in 10 people):
drowsiness, headache, dizziness, worsening of insomnia, anterograde amnesia (which may be associated
with abnormal behavior), hallucinations, agitation, nightmares, depression, fatigue, diarrhoea,
nausea, vomiting, abdominal pain, upper and lower respiratory tract infections, back pain.
Uncommon (may affect up to 1 in 100 people):
confusional state, irritability, restlessness, aggression, somnambulism (see section 2), euphoria,
double vision, paraesthesia (tingling, prickling), tremor, attention disorders, speech disorders,
blurred vision, increased liver enzyme activity, rash, itching, excessive sweating, appetite disturbances,
joint pain, muscle pain, muscle cramps, neck pain, muscle weakness.
Rare (may affect up to 1 in 1,000 people):
libido disorders, consciousness disturbances, drug-induced liver injury, urticaria, visual disturbances,
gait disturbances, falls (especially in elderly patients and when the medicine is not taken as recommended) –
see section 2.
Very rare (may affect up to 1 in 10,000 people):
delusions, dependence (after discontinuation of treatment, withdrawal symptoms or "rebound" phenomena
may occur), respiratory depression (difficulty breathing – see section 2).
Frequency not known (frequency cannot be estimated from the available data):
anger, behavioral disturbances (most psychiatric adverse reactions are related to paradoxical reactions),
angioedema (a severe allergic reaction – swelling may affect the face, limbs, oral cavity, larynx, and may
cause breathing difficulties), drug tolerance.
If any of the following adverse reactions occur, which are more likely in elderly patients, the medicine
should be discontinued immediately: restlessness (especially motor restlessness), worsening of insomnia,
agitation, irritability, aggression, delusions, rage, nightmares, hallucinations, inappropriate behavior,
somnambulism, and other behavioral disturbances.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist,
or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug
Reactions 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,
e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder or the representative
of the marketing authorization holder in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Hypnogen

Keep the medicine out of the 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 stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hypnogen contains

• The active substance is zolpidem. One film-coated tablet contains 10 mg of zolpidem tartrate.
• Other ingredients are: monohydrate lactose, 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 film-coated tablets with a score line on one side to facilitate division.
Pack sizes: 7, 15, 20, 30 or 100 film-coated tablets.
Marketing Authorisation Holder and Manufacturer:
Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
For further information, contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00