5 mg, 10 mg film-coated tablets
Zolpidem tartrate
What Zolpidem STADA is and what it is used for
Zolpidem Stada belongs to a group of medicines called benzodiazepine-like medicines.
Zolpidem Stada is a sleep aid that works by acting on the brain and causing sleepiness. It is used for the short-term treatment of insomnia in adults that is severe, disabling, or causes the patient great discomfort.
The zolpidem tartrate contained in Zolpidem Stada 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 using Zolpidem STADA
Do not use Zolpidem STADA
- if you are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue
- if you have ever sleepwalked or experienced other unusual behaviors during sleep that you performed without being fully awake (such as driving, eating, making a phone call, or having sex, etc.), after taking Zolpidem Stada or other medicines containing zolpidem.
- if you suffer from 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 severe liver problems ( liver insufficiency ).
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zolpidem Stada
- you have liver problems
- you have kidney problems
- you have breathing problems ( respiratory insufficiency )
- you have depression or previously had another mental illness, anxiety, or psychotic illness. Zolpidem Stada can reveal or worsen the symptoms.
- you have or have ever had thoughts of harming yourself or suicidal thoughts. Some studies have shown an increased risk of suicidal ideation, suicide attempts, and suicide in patients taking a certain sedative and sleep medications, including this medicine. If you are having suicidal thoughts, contact your doctor for medical advice as soon as possible.
- you have recently taken Zolpidem Stada or other medicines containing zolpidem for more than 4 weeks
- if you are elderly or infirm. If you get up during the night, be careful. Zolpidem Stada can relax your muscles. This and the calming effect increase the risk of falling accidents and consequently of hip fractures. Your doctor may prescribe a lower dose for you (see section 3. “How to take Zolpidem Stada”)
- If you have ever had any heart problems, including a slow or irregular heartbeat
- you have abused or been addicted to alcohol, drugs, or medicines?
Problems with coordination the following day (see also Driving ability and use of machines ).
The day after taking Zolpidem Stada, 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 functioning of the central nervous system, other medicines that increase zolpidem in the blood, drink alcohol, or use illegal drugs.
Take the tablet as a single dose just before going to bed.
Do not take any additional dose on the same night.
More information
- Getting used to it – If after a few weeks you notice that your tablets are not working as well as they did when you started treatment, you should contact your doctor.
- Dependence – When taking this type of medicine there is a risk of abuse and dependence. The risk increases with the dose and length of treatment. The risk of abuse and dependence is greater in patients who have previously had mental illnesses or abused alcohol, drugs, or medicines. However, addiction can also occur at the normal doses given during treatment and even if you do not exhibit risk factors such as previous alcohol or drug abuse.
- Withdrawal – The treatment should be tapered off gradually. At the end of treatment, a transient syndrome may occur in which the symptoms that led to you being treated with Zolpidem Stada return in an intensified form. (so-called rebound effect )). It can occur along with other reactions such as mood changes, anxiety, and restlessness. You may also experience these types of symptoms between doses when taking this medicine, especially when the dose is high.
- Memory disturbances – This medicine can cause memory disturbances. To reduce the risk, you must ensure that you sleep undisturbed for 8 hours.
- Psychic and “paradoxical” reactions (a “paradoxical” reaction is opposite to the expected effect) – Zolpidem Stada can cause behavioral side effects such as restlessness, inner restlessness ( agitation ), aggressiveness, delusions (false perceptions), tantrums, nightmares, hallucinations ( seeing, hearing or feeling things that are not there), psychosis, inappropriate behavior, and increased sleep disturbances.
- Sleepwalking and similar behaviors – Use of this medication may cause you to do things in your sleep that you do not remember when you wake up. This includes sleepwalking, driving, cooking and eating, making phone calls, or having sex, without being fully awake. If you experience any of the above, stop taking this medicine immediately and consult a doctor. Alcohol and certain medicines used to treat depression or anxiety or using Zolpidem Stada in doses that exceed the maximum recommended dose can increase the risk of these side effects.
- Risk of falls and serious injuries – This medicine can cause drowsiness and a reduced level of consciousness, which can increase the risk of falls and thus serious injuries (see also section 4. “Possible side effects”).
If the sleep problems persist after 7-14 days of treatment, contact a doctor so that your treatment can be re-examined.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Zolpidem Stada.
Children and young people
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and Zolpidem STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines and (traditional) herbal and herbal medicines. This is because Zolpidem Stada can affect how other medicines work and other medicines can affect the effect of Zolpidem Stada.
Zolpidem Stada should be used with caution in combination with other medicines that have a depressant effect on the central nervous system (see section 2. What you need to know before you use Zolpidem Stada).
Concomitant use of Zolpidem Stada and opioid medicines (strong painkillers, medicines for the treatment of opioid dependence, and certain cough medicines) increases the risk of drowsiness, breathing difficulties ( respiratory depression ), and coma, and can be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes Zolpidem Stada at the same time as opioid drugs, the dose and duration of treatment must be limited by the doctor.
Tell your doctor if you are taking any opioid medication and follow your doctor’s dosage recommendations carefully. It may be helpful 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.
Tell your doctor if you are taking any of the following medicines:
The risk of drowsiness and problems with coordination the following day, including impaired ability to
driving may increase when you take Zolpidem Stada at the same time as the following type of medicine:
- Medicines for certain mental problems (antipsychotic medicines)
- Medicines for sleep problems (so-called hypnotics )
- Medicines that suppress or reduce anxiety
- Medicines for depression
- Medicines for moderate or severe pain (so-called narcotic analgesics )
- Medicines for epilepsy
- Medicines used in anesthesia
- Medicines for hay fever, rashes, or other allergies that can make you sleepy (some antihistamines)
If you take Zolpidem Stada at the same time as antidepressants such as bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).
It is not recommended to take Zolpidem Stada together with fluvoxamine (used to treat depression) or ciprofloxacin (used to treat bacterial infections).
The following medicines may increase your risk of side effects when taken at the same time as Zolpidem Stada:
- Medicines that inhibit liver enzymes. Ask your doctor or pharmacist which medicines have this effect (eg ketoconazole, a medicine used to treat fungal infections).
To make this less likely, your doctor may decide to lower your dose of Zolpidem Stada.
The following medicines can reduce the effect of Zolpidem Stada:
- Rifampicin (an antibiotic ) – against infection
- St. John’s wort ((traditional) herbal medicines containing St. John’s wort ) – used for mild depression and mild anxiety – the simultaneous use of Zolpidem Stada and St. John’s wort is not recommended.
Zolpidem STADA with food, drink, and alcohol
Do not drink alcohol while being treated with Zolpidem Stada. Alcohol can increase the effects of Zolpidem Stada and cause you to sleep very deeply so that you do not breathe properly or have difficulty waking up.
Pregnancy and breastfeeding
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 taking this medicine.
Use of Zolpidem Stada during pregnancy is not recommended.
There is a risk that the child will be affected if it is used during pregnancy. Some studies have shown that there may be an increased risk of cleft lip and palate (sometimes called “cleft lip”) in newborns.
Reduced fetal movements and effects on the fetal heart rate may occur after taking Zolpidem Stada during the last six months of pregnancy.
If Zolpidem Stada is taken at the end of pregnancy or during childbirth, the newborn baby may have the following symptoms: muscle weakness, low body temperature, difficulty eating, and breathing problems ( respiratory depression ). With regular use late in pregnancy, the child may develop physical dependence and run the risk of developing withdrawal symptoms such as restlessness and tremors after birth. In this case, the child must be followed up closely by a doctor during the first months after birth.
You should not use Zolpidem Stada if you are breastfeeding, as small amounts of the medicine pass into breast milk.
Driving ability and use of machinery
Zolpidem Stada has a major impact on your ability to drive and use machines, for example so-called “sleep-driving”. The day after you take Zolpidem Stada (as with other medicines for sleep problems), you should be aware that:
- you may feel drowsy, sleepy, dizzy, or confused
- it takes longer for you 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 and driving, using machinery, or working at high altitudes to minimize the effects mentioned above.
Do not drink alcohol or take other psychoactive substances while taking Zolpidem Stada, as this may increase the effects mentioned above.
For more information about possible side effects that may affect your ability to drive, see section 4 of this leaflet.
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 STADA 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 use Zolpidem STADA
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended dose of Zolpidem Stada is 10 mg per 24 hours. Some patients may be prescribed a lower dose.
Only for 10 mg tablet: Zolpidem Stada 10 mg film-coated tablet can be divided into two equal doses (5 mg each) along the score line.
Elderly and patients with reduced general condition
The usual dose is 5 mg taken at bedtime. Your doctor may decide to increase your dose to 10 mg if the effect is insufficient and the medicine is well tolerated.
Patients with impaired liver function
The usual starting dose is 5 mg taken at bedtime. Your doctor may decide to increase your dose to 10 mg if the effect is insufficient and the medicine is well tolerated. Do not take Zolpidem Stada if you have severe liver problems.
Maximum dose
A daily dose of 10 mg must not be exceeded.
Children and young people
Zolpidem Stada is not recommended for children and adolescents under the age of 18.
How to take the tablet
The film-coated tablet should be taken with liquid immediately before bedtime.
Zolpidem Stada 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.
How long should you take Zolpidem Stada?
The duration of the treatment should be as short as possible. In general, it can be a few days up to 2 weeks and not exceed 4 weeks, including the gradual tapering period.
Some situations may require a longer period of use than the maximum treatment time. Your doctor will determine this after re-evaluating your sleep problems.
If you have used too much Zolpidem STADA
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, immediately contact a doctor or hospital for an assessment of the risk and advice. Bring the medicine package with you. This is so that the doctor knows what you have taken. Do not go unaccompanied when seeking medical care.
Taking too much Zolpidem Stada can be very dangerous. The following symptoms may occur:
- drowsiness, confusion, deep sleep, and possibly coma which can be life-threatening.
If you forget to use Zolpidem STADA
Zolpidem Stada may only be taken at bedtime. If you forget to take your dose at bedtime, do not take it at any other time, otherwise, you may feel drowsy, dizzy, and confused during the day. Only take the missed dose if you are still able to sleep uninterrupted for 8 hours. If this is not possible, take the next dose at bedtime the following evening. Do not take a double dose to make up for a forgotten dose.
If you stop using Zolpidem STADA
The treatment must be tapered off gradually, otherwise, the symptoms for which you are being treated may return more intensely than before (so-called rebound effect ). Anxiety, restlessness, and mood swings can also occur. These effects eventually wear off.
If you have become physically dependent on Zolpidem Stada, sudden discontinuation of treatment leads to side effects such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, and insomnia. In serious cases, other side effects may occur, e.g. hypersensitivity to light, noise, and physical touch, abnormally sensitive hearing and painful sensitivity to sound, hallucinations, numbness, and tingling in the arms and legs, derealization (a feeling that the outside world is not real), depersonalization (a feeling that your mind is separated from the body) or epileptic seizures (violent convulsions or tremors). These symptoms may also be experienced between doses, especially if the dose is high.
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 Stada and see a doctor immediately or go to the hospital immediately if:
- You have an allergic reaction. Symptoms may include rash, swallowing or breathing problems, and swelling of your lips, face, throat, or tongue ( angioedema ). This has been reported (occurring in an unknown number of users).
Other side effects that may occur:
Common (may affect up to 1 in 10 users):
- memory disorders such as poor memory ( amnesia ), memory impairment, and temporary memory gaps (anterograde amnesia ). This is more likely to affect you within a few hours of taking this medicine. Having 8 hours of sleep after taking Zolpidem Stada, is less likely to cause you problems.
- worsened sleep problems after taking this medicine
- seeing or hearing things that are not real (hallucinations)
- drowsiness or a strong desire to sleep (may also occur the next day)
- dizziness
- blurred vision or double vision
- diarrhea
- nausea, vomiting
- abdominal pain
- Infection in the upper and lower respiratory tract
- headache
- fatigue
- indignation
- nightmares
- Depression
- back pain
- decreased alertness
- coordination disorders ( ataxia )
- “spinning” sensation ( vertigo ).
Uncommon (may affect up to 1 in 100 users):
- appetite disorders
- driving without being fully awake or other behaviors that are unusual during sleep (sleepwalking, having sex during sleep)
- A strong feeling of happiness or self-confidence ( euphoria )
- unsteady gait, falls (falling over), especially for older people
- confusion, confusion
- restlessness, anger
- attention deficit disorder
- speech disorder
- joint pain, aching muscles, muscle cramps
- neck pain
- abnormal or tingling sensation in the skin ( paresthesia )
- tremors
- increased levels of liver enzymes (detected in a blood test)
- itching of the skin or rash
- profuse sweating
- muscle weakness
Rare (may affect up to 1 in 1,000 users):
- impaired vision (visual impairment)
- reduced level of consciousness
- changes in sexual desire ( libido )
- hives
- liver damage (damage to liver cells, gallbladder, or a combination).
Very rare (may affect up to 1 in 10,000 users):
- Addiction to Zolpidem Stada where you feel the need to keep taking it to feel normal (see section 2 “Warnings and precautions”)
- Breathing problems ( respiratory depression )
- delusions.
Has been reported (occurring in an unknown number of users):
- anger or various changes in behavior (abnormal behavior)
- Zolpidem Stada has less effect than normal (habituation, see section 2 “Warnings and precautions”).
How to store Zolpidem STADA
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and the blister pack after EXP. The expiration date is the last day of the specified month.
Store in the original packaging.
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 5 mg and 10 mg respectively
Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, type A sodium starch glycollate, hypromellose, and magnesium stearate,
Tablet coating : titanium dioxide (E171), hypromellose and macrogol 400.
Appearance and package sizes of the medicine
Zolpidem Stada 5 mg film-coated tablets are white to off-white, oval, biconvex, film-coated tablets marked with “ZIM” and “5” on one side.
Zolpidem Stada 10 mg film-coated tablets are white to off-white, oval, biconvex with a score and marked with “ZIM” and “10” on one side. The tablet can be divided into equal doses (5 mg) along the score line.
The film-coated tablets are packaged in:
- blister in a carton containing 4, 5, 7, 10, 14, 15, 20, 25, 28, 30, 40, 50, 60, 70, 80, 90, 100, 150, or 500 tablets.
- cans containing 30, 100, or 500 tablets, sealed with a child-resistant lid.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Synthon Hispania SL
Castello Poligono Las Salinas, Sant Boi de Liuobregat, Spain
Synthon BV
Miroweg 22, 6545 CM Nijmegen, The Netherlands
Centrafarm Services BV
Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands
PharmaCodane ApS
Marielundvej 46A, 2730 Herlev, Denmark
Stada Arzneimittel Ges.mbH (10 mg only)
Heiligenstädter Str-52/2/8, 1090 Vienna, Austria
Sanico NV
Veedijk 59, Industriezone 42300, Turnhout, Belgium
Clonmel Healthcare Ltd.
Waterford Road, Clonmel, Co. Tipperary, Ireland
Eurogenerics NA/SA
Heizel Esplanada Heysel b 22, B-1020, Brussels, Belgium
Local Representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark