10 mg film-coated tablets
zolpidem tartrate
What Zolpidem Hexal is and what it is used for
Zolpidem Hexal is used for the short-term treatment of insomnia in adults. Do not use it for a long time. The treatment time should be as short as possible because the risk of addiction increases with the length of the treatment.
The medicine is only used if the insomnia is severe, disabling, or causes the patient great discomfort.
The zolpidem tartrate contained in Zolpidem Hexal may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Zolpidem Hexal
Do not take Zolpidem Hexal
- if you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6)
- if you have a certain type of muscle weakness ( myasthenia gravis )
- if you have temporary pauses in breathing when you sleep ( sleep apnea )
- if you have acute and/or severe breathing problems ( respiratory insufficiency )
- if you have severely impaired liver function ( liver insufficiency )
- if you have ever sleepwalked or experienced other unusual behavior during sleep after taking Zolpidem Hexal or other medicines containing zolpidem. It can e.g. be driving, eating, making a phone call, or having sex without being fully awake.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zolpidem Hexal.
Generally
Before starting treatment with Zolpidem Hexal, the
- the cause of the sleep problems is determined as well as the possibilities of treating these without drugs
- underlying diseases are treated.
If the sleep problems persist after 7-14 days of treatment with Zolpidem Hexal, the doctor will carry out more examinations to investigate the causes.
Tolerance
Repeated use of sleeping pills for a few weeks can cause the effect to decrease (tolerance).
Dependent
Use of Zolpidem Hexal can lead to the development of addiction and/or physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is greater if zolpidem is used for more than 4 weeks. The risk of abuse and dependence is greater in patients who have previously had mental illnesses and/or abused alcohol, drugs, or medicines. Tell the doctor if you have or have had a mental illness, if you abuse or have abused alcohol, drugs, or medicines, or if you are or have been dependent on these substances.
Withdrawal symptoms
If a physical dependence has developed, sudden discontinuation of treatment leads to withdrawal symptoms such as headache, muscle pain, anxiety and tension, restlessness, confusion, and irritability. In severe cases, feelings of unreality, personality changes, hearing changes (increased sound perception, hyperacusis), numbness and tingling in the arms and legs, hypersensitivity to light, sound, and touch, hallucinations, and epileptic seizures may occur. The treatment should therefore be ended slowly by gradually reducing the dose. Zolpidem can cause withdrawal symptoms even between doses.
When treatment ends, temporary withdrawal symptoms may occur and the symptoms that led to treatment with Zolpidem Hexal may return in an aggravated form. It can be accompanied by mood swings, anxiety, and restlessness. Since the risk of withdrawal or withdrawal symptoms is higher if treatment is stopped suddenly, treatment should be stopped slowly by gradually reducing the dose.
When Zolpidem Hexal is taken according to the recommendations given regarding dose and duration of treatment, and warnings and precautions are followed, the risk of withdrawal – or withdrawal symptoms when treatment ends is minimal.
Zolpidem Hexal is not recommended as a basic treatment for certain mental illnesses ( psychosis ).
Depression
As with other hypnotics or sedatives, Zolpidem Hexal should be used with caution in patients with symptoms of depression or anxiety accompanied by depression. In some circumstances, the symptoms of depression may worsen if the underlying illness is not treated appropriately (with antidepressants). This may increase the risk of suicide in these patients. A previously hidden depression may become apparent when taking Zolpidem Hexal. Some studies have shown an increased number of suicides or suicide attempts in patients taking certain sleeping pills or tranquilizers, including Zolpidem Hexal.
However, it has not been established whether this is due to the drug treatment or whether it may have other causes.
If you have suicidal thoughts (thinking about harming yourself or committing suicide) or suicidal behavior, contact your doctor as soon as possible.
Memory lapses ( amnesia )
Sleeping pills can cause short and temporary memory lapses (anterograde amnesia ). This means that after taking this medicine (usually a few hours later) you may do things that you then do not remember. It can also be about inappropriate behavior. How big the risk of memory gaps depends on the dose. To minimize the risk, make sure you get 8 hours of undisturbed sleep.
Psychic and paradoxical reactions
Zolpidem Hexal can cause psychological and so-called “paradoxical reactions”, such as restlessness, worsening insomnia, agitation, irritability, aggressiveness, delusions, outbursts of anger, nightmares, hallucinations (seeing, hearing or feeling things that are not there), abnormal behavior and other behavioral disorders, especially in elderly patients (see section 4). If this occurs, treatment with Zolpidem Hexal should be discontinued (see section 4).
Bedtime
Sleepwalking and similar behaviors have also been reported in patients taking zolpidem who were not fully awake. This includes driving, cooking and eating, making phone calls, or having sex without remembering it when you wake up. If you notice any of the above behaviors, stop taking Zolpidem Hexal immediately and consult a doctor, as these sleep behaviors can pose serious risks to you and others. Drinking alcohol or taking other drugs that make you sleepy along with zolpidem can increase the risk of these sleep behaviors occurring.
Coordination problems
Coordination problems the following day (see also “Driving ability and use of machines”)
Like other hypnotics and sedatives, Zolpidem Hexal can have a depressant effect on the central nervous system.
The day after taking Zolpidem Hexal, the risk of coordination problems, including impaired driving ability, may be greater if:
- you take this medicine less than 8 hours before performing activities that require alertness
- you are taking a higher dose than recommended
- you take zolpidem at the same time as you take other sedatives that affect the function of the central nervous system, other medicines that increase zolpidem in the blood, drink alcohol, or use drugs or medicines.
Take the full dose just before going to bed.
Do not take any additional dose on the same night.
The use of zolpidem has been associated with an increased risk of falls. The falls can be caused by side effects such as coordination problems, muscle weakness, dizziness, drowsiness, and fatigue. The risk of falling is higher in elderly patients if a higher-than-recommended dose is used.
Impaired respiratory and liver function
Patients with chronically impaired respiratory function or impaired liver function should be treated with caution and the doctor may prescribe a lower dose of Zolpidem Hexal (see also section 3). Due to the risk of brain damage, patients with severely impaired liver function should not be treated with Zolpidem Hexal.
Heart problems
Patients with a specific congenital disease of the electrical conduction of the heart (so-called ” long QT syndrome “) should be treated with caution. The doctor will carefully consider the benefits against the risks before prescribing treatment with Zolpidem Hexal.
Elderly patients and patients with reduced general condition
These patients should receive a lower dose (see section 3). Caution is required when prescribing to elderly patients due to the risk of falls, especially when getting up at night.
Children and young people
Zolpidem Hexal is not recommended for children and adolescents under 18 years of age as there are insufficient clinical data for this age group
Other medicines and Zolpidem Hexal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines can affect the effect of Zolpidem Hexal or can be affected by Zolpidem Hexal:
The risk of drowsiness and problems with coordination the following day, including impaired ability to drive, maybe higher the day after taking zolpidem if it is taken at the same time as the following medicines:
- medicines for certain mental problems (antipsychotics)
- medicines for sleep problems ( hypnotics )
- drugs that suppress or reduce anxiety
- medication for depression
- medicines for moderate or severe pain (narcotic analgesics )
- drugs against epilepsy
- drugs used in anesthesia
- medicines for hay fever, rashes, or other allergies that can make you sleepy ( sedative antihistamines ).
Simultaneous use of Zolpidem Hexal and opioid medicines (strong painkillers, medicines for the treatment of patients who have become addicted to opioids, as well as certain cough medicines) increases the risk of drowsiness, breathing difficulties ( respiratory depression ), coma and can be life-threatening. Because of this, concomitant use should only be considered by the physician when other treatment options are not possible.
If your doctor prescribes Zolpidem Hexal together with opioid medicines, the doctor must limit the dose and duration of treatment for simultaneous treatment.
Tell your doctor if you are taking any opioid medication and follow your doctor’s dosage recommendations carefully. It may be good to inform friends or relatives to be aware of the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Combination with opiate-type painkillers (narcotic analgesics ) can also lead to an addiction developing more quickly.
If you take zolpidem at the same time as antidepressants such as bupropion, desipramine, fluoxetine, sertraline, or venlafaxine, you may see things that are not real (hallucinations).
You are advised not to take zolpidem together with fluvoxamine or ciprofloxacin.
With the simultaneous use of muscle relaxants, the effect of muscle relaxants can be increased – especially in elderly patients and at higher doses (risk of falling accidents!).
Medicines that increase the activity of certain liver enzymes (especially P450 isoenzyme et CYP3A4) can reduce the effect of Zolpidem Hexal (eg rifampicin, carbamazepine, phenytoin, and St. John’s wort ). Concomitant use of zolpidem and St. John’s wort is not recommended.
Certain medicines against fungal infections (azoles eg ketoconazole ) and certain antibiotics ( macrolide antibiotics ) can, on the other hand, increase the effect of Zolpidem Hexal because they weaken the effect of these liver enzymes.
Zolpidem Hexal with food, drink, and alcohol
You should not drink alcohol during treatment, as this alters and enhances the effect of zolpidem unpredictably. The ability to carry out tasks that require increased concentration is also reduced by this combination. Grapefruit juice may increase the effect of Zolpidem Hexal.
Pregnancy, breastfeeding, and fertility
Pregnancy
Use of Zolpidem Hexal is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor.
If this medicine is used during pregnancy, there is a risk that the baby will be affected.
Some studies have shown that there may be an increased risk of cleft lip and palate (“harmynthet”) in newborn child.
Decreased fetal movements and changes in fetal heart rate may occur after taking Zolpidem Hexal during the last six months of pregnancy.
If Zolpidem Hexal is taken at the end of pregnancy or during childbirth, the child may suffer from muscle weakness, lower body temperature, problems with eating, and breathing problems ( respiratory depression ).
If this medicine is taken regularly during the latter part of pregnancy, the child may develop a physical dependence and is at risk of suffering withdrawal symptoms in the form of agitation and tremors. In such cases, the newborn should be closely monitored after birth.
Breast-feeding
Because zolpidem is excreted in breast milk in small amounts, Zolpidem Hexal should not be used during breastfeeding.
Fertility
There are no data on the effects on fertility.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Zolpidem Hexal has a major impact on the ability to drive and use machines, for example when sleepwalking and driving when you are not fully awake (“sleep-driving”). The day after you take Zolpidem Hexal (as well as other sleeping pills), you should be aware that:
- you may feel drowsy, sleepy, dizzy, or confused
- it may take you longer to make a quick decision
- you may see blurry or double
- you can pay less attention.
A period of at least 8 hours is recommended between taking Zolpidem Hexal and driving, using machinery, or working at high altitudes to minimize the above-mentioned effects.
Do not drink alcohol or take other psychoactive substances while taking Zolpidem Hexal, as this may increase the above-mentioned effects.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zolpidem Hexal contains lactose and sodium
If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to take Zolpidem Hexal
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Recommended dose
Adults
The recommended dose is 10 mg of zolpidem (1 film-coated tablet of Zolpidem Hexal) per 24 hours. Some patients may be prescribed a lower dose. Zolpidem Hexal should be taken:
- as a single dose
- in connection with bedtime.
Make sure that a period of at least 8 hours has passed after taking this medicine before doing activities that require you to be awake/alert.
Never take more than 10 mg per 24 hours.
Elderly patients and patients with reduced general condition
The recommended dose is 1/2 film-coated tablet (5 mg) of Zolpidem Hexal for elderly patients and patients with impaired general health, as they may be particularly sensitive to Zolpidem Hexal. This dose should only be increased to 10 mg (1 film-coated tablet) if the effect is insufficient and the drug is well tolerated.
Breathing problems or impaired liver function
For patients with breathing problems or impaired liver function, the dose is 1/2 film-coated tablet (5 mg) of Zolpidem Hexal
Children and young people
Zolpidem Hexal is not recommended for children and adolescents under 18 years of age as there are insufficient data to support use in this age group.
How to take the tablet
Zolpidem Hexal should be taken with some liquid (water) immediately before bedtime or in bed.
The tablet can be divided into two equal doses.
How long should you take Zolpidem Hexal?
The treatment period should be as short as possible, generally only a few days up to 2 weeks, and should not exceed 4 weeks, including the step-by-step tapering period.
In some cases, longer treatment may be necessary. However, the treatment should not be extended without a renewed medical assessment of your condition.
If you have taken too much Zolpidem Hexal
If you have taken too much, you must contact a doctor immediately.
Signs of a (small) overdose can be drowsiness, dizziness, blurred vision, slurred speech, lowered blood pressure, unsteady gait and unsteady movements, muscle weakness, confusion, and hallucinations. In more serious overdoses, symptoms can range from deep sleep to unconsciousness, agitation, breathing problems, and circulatory collapse. Cases of zolpidem overdose (alone or in combination with other drugs that depress the central nervous system, including alcohol) have been reported with serious consequences (even life-threatening).
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Zolpidem Hexal
Do not take a double dose to make up for a missed dose. Continue to take Zolpidem Hexal as prescribed by your doctor.
If you stop taking Zolpidem Hexal
If you want to stop the treatment, you should first discuss it with the doctor. Do not stop treatment on your initiative without receiving medical advice. As the risk of withdrawal symptoms is higher if the treatment is stopped suddenly, the doctor will advise you to stop by gradually reducing the dose, see section 2 “Warnings and precautions”, paragraph “Withdrawal symptoms”.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking zolpidem and contact a doctor or go to the hospital immediately if you develop an allergic reaction ( angioedema ). Signs of such a reaction may include raised and itchy rashes ( hives ), and swelling of the hands, feet, ankles, face, lips, or throat which may lead to difficulty swallowing or breathing.
Side effects can be dose-dependent, especially side effects that affect the central nervous system. To reduce such side effects, it is recommended that zolpidem be taken immediately before bedtime or in bed. Side effects are more common in older people.
Tell your doctor as soon as possible if you get any of the following side effects:
Common (may affect up to 1 in 10 users)
- drowsiness
- increased insomnia
- nightmares
- fatigue
- headache
- dizziness
- the cognitive impact such as temporary memory lapses (anterograde amnesia, possibly with inappropriate behavior)
- hallucinations
- increased activity level
- Depression
- diarrhea
- nausea or vomiting
- stomach pains
- upper respiratory tract infection
- lower respiratory tract infection
- back pain.
Uncommon (may affect up to 1 in 100 users)
- appetite disorders
- confusion
- irritability
- restlessness
- aggressiveness
- sleepwalking or other behaviors that are unusual during sleep, such as driving, eating, talking on the phone, or having sex without being fully awake (see section “Warnings and precautions”)
- euphoria
- sensory disturbances such as tingling or numbness ( paresthesia )
- tremors
- impaired attention
- speech disorder
- double vision
- blurred vision
- elevated liver enzymes
- rash
- itching
- profuse sweating ( hyperhidrosis )
- joint pain
- muscle pain
- muscle cramps
- neck pain
- muscle weakness.
Rare (may affect up to 1 in 1,000 users)
- sexual dysfunction
- impaired vision
- liver damage (damage to liver cells, gallbladder, or a combination) (see also section 2 “What you need to know before taking Zolpidem Hexal” and section 3)
- hives
- unsteady gait
- falls (especially in elderly patients or if Zolpidem Hexal is not taken as prescribed )
- reduced level of consciousness.
Very rare (may affect up to 1 in 10,000 users)
- delusions
- dependence ( withdrawal or withdrawal symptoms may occur when treatment is stopped)
- breathing problems.
Has been reported (occurring in an unknown number of users)
- outbursts of anger
- abnormal behavior
- tolerance development
- persistent swelling of the skin and mucous membranes ( angioedema )
- abuse.
How to store Zolpidem Hexal
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and the blister card after EXP.
The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive.
No special temperature instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is zolpidem tartrate.
1 film-coated tablet contains 10 mg of zolpidem tartrate.
Other ingredients are:
Tablet core: succinic acid, sodium starch glycolate (type A), microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide.
Tablet coating: lactose monohydrate, macrogol 4000, hypromellose, titanium dioxide (E 171).
Appearance and package sizes of the medicine
White, glossy, oblong film-coated tablets, biconvex, and scored on one side.
The film-coated tablets are packed in polyvinyl chloride/aluminum blisters in a cardboard box.
The package contains 10, 20, 28, 30, 30×1, 50, 98, and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Hexal A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany