10 mg film-coated tablets
zolpidem tartrate
What Zolpidem Mylan is and what it is used for
Zolpidem Mylan contains zolpidem which belongs to a group of medicines called benzodiazepines. Zolpidem Mylan is a sleep aid that exerts its effect on the brain and causes fatigue.
This medicine is used in the short-term treatment of severe insomnia ( insomnia ) in adults that have an extensive impact on everyday life or that causes great discomfort. Insomnia means difficulty falling asleep or sleeping well.
The zolpidem contained in Zolpidem Mylan may also be approved to treat other conditions not mentioned in this leaflet. Ask a doctor or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Zolpidem Mylan
Do not use Zolpidem Mylan:
- if you are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest itself as a rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
- if you have severely impaired liver function
- if you have heavy snoring with temporary pauses in breathing when you sleep ( sleep apnea )
- if you have the muscle disease myasthenia gravis.
- if you have acute and/or severe breathing problems
Warnings and precautions:
Talk to your doctor before taking this medicine:
- if you are elderly or infirm. If you get up during the night, be careful as Zolpidem Mylan can relax your muscles. This increases the risk of falling and consequently the risk of hip fractures.
- if you have kidney or liver problems
- or if you have previously had difficulty breathing. While taking Zolpidem Mylan, breathing may become less vigorous.
- if you have previously had any mental illness, anxiety, or psychotic illness. Zolpidem may trigger or worsen symptoms.
- if you suffer from or have had depression (feeling down)
- if you abuse or have abused alcohol or drugs. The risk of dependence on Zolpidem Mylan (physical or psychological effects that cause a compulsion to continue taking the medicine) increases with the dose and duration of treatment.
Other information
- Getting used to it – if you notice after a few weeks that the tablets do not work as well as they did when you started the treatment, you should contact your doctor. Adjustment of dose may be needed.
- Dependence – when taking this type of medicine, there is a risk of dependence, which increases with the dose and the duration of treatment. The risk is greater if you have previously abused alcohol, other substances, or drugs. However, dependence can also occur at the normal doses given during treatment and for patients who do not exhibit individual risk factors.
- Withdrawal – treatment with this medicine must be gradually tapered off. Withdrawal symptoms may occur during a short period where the symptoms that led you to start treatment with Zolpidem Mylan return in an intensified form. It may be accompanied by other reactions such as mood swings, anxiety, and restlessness.
- Memory loss – Zolpidem Mylan can cause memory loss. To reduce the risk, make sure you get 8 hours of uninterrupted sleep.
- Psychic and ‘paradoxical’ reactions – Zolpidem Mylan can cause behavioral side effects such as restlessness, excitement, irritability, aggressiveness, delusions, anger, nightmares, hallucinations, seeing, hearing, or feeling things that are not there), psychosis (loss of reality, difficulties thinking and making clear judgments), inappropriate behavior, and increased insomnia.
- Sleepwalking and other similar behaviors – The use of Zolpidem Mylan may cause people to do things in their sleep that they do not remember when they wake up. This includes sleepwalking, driving, cooking and eating, making phone calls, and having sex. Alcohol and certain medicines used for depression and anxiety or using Zolpidem Mylan at doses greater than the highest recommended dose can increase the risk of these side effects.
- Falls and injuries – zolpidem can make you drowsy or reduce your level of consciousness, which can lead to falls and injuries.
- Suicidal ideation, suicide attempt, and suicide – Some studies have shown an increased risk of suicidal ideation, suicide attempt, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is due to the drug treatment or whether it may have other causes. If you are having suicidal thoughts, contact your doctor for medical advice as soon as possible.
- Problems with coordination the following day (see also Driving ability and use of machines). The day after taking Zolpidem Mylan, 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.
Other medicines and Zolpidem Mylan
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. The effect of Zolpidem Mylan can affect or be affected by other medicines. If you are going to have surgery under general anesthesia, you must tell your doctor which medicines you are using.
The risk of drowsiness and problems with coordination the next day, including impaired ability to drive, may increase when you take zolpidem at the same time as the following type of medicine:
- Medicines for certain mental problems (antipsychotics)
- Medicines for sleep problems ( hypnotics )
- Medicines that suppress or reduce anxiety
- Muscle relaxant drugs
- Medicines for depression
- Medicines for moderate or severe pain (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 at the same time as antidepressants such as bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).
You are not recommended to take zolpidem together with fluvoxamine or ciprofloxacin.
The simultaneous use of Zolpidem Mylan and opioid medicines (strong painkillers, medicines for the treatment of patients who have become addicted to opioids and 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 the doctor prescribes Zolpidem Mylan 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.
The following medicines may increase the sedative effect of Zolpidem Mylan:
- drugs that inhibit liver enzymes. Ask your doctor or pharmacist which medicines have these effects (eg ketoconazole, a medicine used against fungal infections).
Rifampicin, a medicine used against tuberculosis, can reduce the effect of Zolpidem Mylan.
(Traditional) herbal medicines containing St. John’s wort and used for depression should not be taken at the same time as zolpidem as it may reduce the effect of Zolpidem Mylan.
Zolpidem Mylan with alcohol
You should not consume alcohol in connection with the use of Zolpidem Mylan as the sedative effect of the medicine may be enhanced.
Pregnancy and breastfeeding
Use of Zolpidem Mylan during pregnancy is not recommended. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
There is a risk that the baby will be affected if Zolpidem Mylan is used during pregnancy. Some studies have shown that there may be an increased risk of cleft lip and palate in newborns. Decreased fetal movements and effects on the fetal heart rate may occur after taking zolpidem during the last six months of pregnancy.
If for urgent medical reasons you take Zolpidem Mylan during the latter part of pregnancy or labor, the baby may suffer from low body temperature, muscle weakness, difficulty eating, and breathing difficulties and the baby may develop withdrawal symptoms such as restlessness and tremors after birth due to physical dependence. Children who develop withdrawal symptoms should be followed up closely by doctors in the first months after birth.
Do not breastfeed your baby as small amounts of zolpidem may pass into breast milk.
Driving ability and use of machinery
Zolpidem Mylan has a major impact on your ability to drive and use machines, for example so-called “sleep-driving”. The day after you take Zolpidem Mylan (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 blurred or double vision
- You can be less attentive
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 Mylan, as this may increase the effects mentioned above.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Zolpidem Mylan contains lactose
If you are intolerant to certain sugars, such as lactose, consult your doctor before taking this medicine.
How to use Zolpidem Mylan
Always use Zolpidem Mylan as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The tablets work quickly and should be swallowed whole with liquid.
The tablets can be divided into two equal doses.
Adults: The recommended dose of Zolpidem Mylan is 10 mg per 24 hours. Some patients may be prescribed a lower dose. Zolpidem Mylan 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 (over 65 years) or people with impaired general condition: The recommended dose is 5 mg.
Patients with impaired liver function: The recommended starting dose is 5 mg. Your doctor may decide to increase this dose to 10 mg if it is safe to do so. The maximum single dose of 10 mg must not be exceeded by any patient
Children and adolescents: Zolpidem Mylan should not be taken by patients under 18 years of age.
If you notice that the tablets do not work as well as they did when you started the treatment, you should contact your doctor. Adjustment of dose may be needed.
Treatment time
The treatment time must be as short as possible. In general, the treatment time varies from a few days up to two weeks. Treatment should not last longer than four weeks including tapering of dose one.
Your doctor will give you a tapering schedule based on your individual needs. In some cases, you may need to take Zolpidem Mylan for longer than four weeks.
If you have taken too much Zolpidem Mylan
If you have ingested too much medicine, or if e.g. if a child has ingested the medicine by mistake, contact a doctor or hospital. Take the jar and remaining tablets with you. Do not go unaccompanied to seek medical care. If an overdose has occurred, you can quickly become very tired, and high doses can lead to coma and even death.
If you forget to take Zolpidem Mylan
If you forget to take a dose immediately before going to bed but remember it during the night, only take the missed dose if you still have 8 hours of sleep. If this is not possible, take the next dose before going to bed the following night. You should not take this medicine at any other time of the day as it may make you feel drowsy, dizzy, or confused. Do not take double doses to make up for missed doses. Ask your doctor or pharmacist if you are worried.
If you stop taking Zolpidem Mylan
Use the medicine until your doctor tells you to stop. Do not stop taking the medicine suddenly, but tell your doctor if you want to stop. The treatment must be discontinued gradually, otherwise, the sleep problems you were treated for may return in a stronger form. Anxiety, restlessness, and mood swings may also occur. These effects disappear over time.
If you have become physically dependent on Zolpidem Mylan, suddenly stopping the treatment can lead to side effects such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, and insomnia. In severe cases, other effects may occur such as hypersensitivity to light, sound, and physical contact, abnormal acute hearing and painful sensitivity to sound, hallucinations, numbness, and tingling in arms and legs, feeling of unreality, depersonalization (feeling that your consciousness is separated from your body ) or epileptic seizures (violent fits or shaking). These symptoms may also occur between dosing sessions, especially if the dose is high.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur, stop taking Zolpidem Mylan and talk to your doctor immediately or go to the nearest hospital.
Common (may affect up to 1 in 10 users) :
- Memory loss (which may be associated with inappropriate behavior (see section 2 “Other Information”)
Rare (may affect up to 1 in 1,000 users):
- itchy skin with yellowing of the skin or eyes, stomach pain, dark urine, fever, or chills. This could be a sign of liver problems.
- severe sleepiness or tiredness, difficulty concentrating, or difficulty carrying out normal activities
Very rare (may affect up to 1 in 10,000 users):
- physical dependence: use (even at normal doses) can lead to physical dependence, and sudden discontinuation of treatment can lead to withdrawal symptoms and a return of the original problems
- psychological dependence: this is when you think you will never be able to sleep unless you take Zolpidem Mylan
Has been reported (occurring in an unknown number of users):
- allergic reactions such as skin rash, itching, swelling of the face, lips, tongue, or throat, and difficulty breathing, or swallowing.
- breathing difficulties
- psychosis (loss of reality, difficulty thinking and making clear judgments
These side effects are serious. You may need medical attention.
The risk of memory loss is greater at higher doses. To reduce the risk, one should ensure the possibility of 8 hours of uninterrupted sleep.
Tell your doctor or pharmacist if any of the following side effects occur or worsen:
Common (may affect up to 1 in 10 users):
- hallucinations, agitation, nightmares
- drowsiness, headache, dizziness, increased difficulty sleeping
- feeling of dizziness
- Drowsiness the following day decreased ability to react
- diarrhea, nausea, vomiting
- skin reactions
- back pain
- fatigue
- stomach ache
- infection in your nose or throat
- double vision
- depression (feeling down)
Uncommon (may affect up to 1 in 100 users):
- confusion
- irritation
- blurred vision
- muscle weakness, coordination disorders, tingling or numbness, tremors, muscle pain, muscle spasms, joint pain, neck pain
- restlessness, aggression
- sleepwalking
- increased level of certain liver enzymes (this is detected if your doctor takes a blood test)
- skin rash, itching
- excessive sweating
Rare (may affect up to 1 in 1,000 users):
- altered sex drive
- hives
- change in the way you walk
- falls, especially in the elderly
Very rare (may affect up to 1 in 10,000 users):
- delusions (imagination)
Has been reported (occurring in an unknown number of users):
- impaired ability to coordinate movements
- anger, and inappropriate behavior.
- need for higher and higher doses to get the same effect
How to store Zolpidem Mylan
Store out of sight and reach of children.
Store at a maximum of 25 o C. Store in the original packaging.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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 ingredient is zolpidem tartrate 10 mg. Each tablet contains 10 mg of zolpidem tartrate.
The other ingredients are lactose monohydrate 49.4 mg (see section 2 “Zolpidem Mylan contains lactose”), microcrystalline cellulose, pregelatinized corn starch, magnesium stearate, hypromellose, polysorbate 80 (E433), titanium dioxide (color E171) and macrogol 400.
Appearance and package sizes of the medicine
Zolpidem Mylan 10 mg tablet is white to off-white, capsule-shaped, film-coated, scored, and marked with “ZM” and “10” on one side and “G” on the other side. The tablets can be divided into two equal doses.
Zolpidem Mylan tablets are available in blister packs or blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 100, or 250 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer
Generics [UK] Limited, Station Close, Potters Bar, Herts EN6 1TL, United Kingdom
Gerard Laboratories, 35/36 Baldoyle Industrial Estate Grange Road Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary