5 mg and 10 mg film-coated tablets
zolpidem tartrate
What Zolpidem Ratiopharm is and what it is used for
Zolpidem Ratiopharm is a sleep aid that belongs to the group of benzodiazepine-related medicines. It is used in the short-term treatment of sleep difficulties in adults.
Zolpidem Ratiopharm is only prescribed for severe sleep problems, causes weakness or great discomfort, and has an extensive impact on everyday life.
Zolpidem contained in Zolpidem Ratiopharm may also be approved to treat other diseases not mentioned in this leaflet. 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 you use Zolpidem Ratiopharm
Do not take Zolpidem Ratiopharm
- if you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from severe muscle weakness ( myasthenia gravis ).
- if you have short pauses in breathing when you sleep (sleep apnea syndrome).
- if you have severe breathing problems.
- if you have severe liver damage (liver failure).
Warnings and precautions
Generally
Talk to your doctor or pharmacist before taking Zolpidem Ratiopharm.
Before treatment with this medicine,
- the cause of the seam disturbances is being investigated.
- any underlying diseases are treated.
If the treatment of the sleep disturbances has no effect after 7-14 days, this may indicate a mental or physical illness that should be checked.
General information about the effects that have been observed after the use of this drug and other similar hypnotics is described below.
- Getting used to it
If, after a few weeks of treatment, you notice that you are not getting the same effect from the tablets as you did at the beginning of the treatment, you should contact your doctor as an adjustment of your dose may be necessary. - Dependence
Physical or psychological dependence can develop.
The risk increases with the dose and length of treatment and is greater in patients who have previously abused alcohol or drugs. If physical dependence has occurred, sudden discontinuation of treatment causes withdrawal symptoms (see section 3 “If you stop taking Zolpidem Ratiopharm”). - Withdrawal symptoms
When treatment is suddenly stopped, sleep disturbances may return in an increased form (so-called rebound effect ). It can occur together with other reactions such as mood swings, anxiety, and restlessness (see section 3 “If you stop taking Zolpidem Ratiopharm”). - Memory disturbances ( amnesia )
Zolpidem Ratiopharm can cause memory disturbances for several hours after intake. To minimize this risk, make sure you can sleep undisturbed for 8 hours. - Psychiatric and “paradoxical” reactions
Zolpidem Ratiopharm can cause various types of behavioral disorders, such as restlessness, anxiety, irritability, aggressiveness, delusions ( psychosis ), rage, nightmares, hallucinations, sleepwalking, inappropriate behavior, increased sleep disturbances, and other behavioral disturbances. These reactions occur more often in the elderly. Tell your doctor if you get such symptoms as the use of Zolpidem Ratiopharm should be stopped. - Sleepwalking and other similar behaviors
There have been reports of patients doing things in their sleep they don’t remember when they wake up after taking sleeping pills. This can be sleepwalking, driving, cooking and eating, talking on the phone, or having sex. If someone close to you notices such reactions, contact the doctor. - Problems with coordination the following day (see also “Driving ability and use of machines”)The day after taking Zolpidem Ratiopharm, 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.
Special patient groups
Caution should be exercised when benzodiazepines and benzodiazepine-related medicines (such as Zolpidem Ratiopharm) are given to:
- Elderly and frail patients
They should receive a lower dose (see section 3 “How to take Zolpidem Ratiopharm”).
Zolpidem Ratiopharm has a muscle-relaxing effect. Therefore, especially older patients have an increased risk of falling over and, as a consequence, suffering hip fractures when they get out of bed at night. - Patients with impaired kidney function
Tell your doctor if you have impaired kidney function. It may take longer for your body to get rid of Zolpidem Ratiopharm. Although it is not necessary to change the dose one, caution should be exercised. - Patients with chronic shortness of breath
Some medicines for insomnia can impair breathing. - Patients who have previously abused alcohol and drugs
Extreme caution must be observed. These patients should be closely monitored during treatment with Zolpidem Ratiopharm, as they have an increased risk of habituation and psychological dependence.
Zolpidem Ratiopharm and similar sleeping pills should not be used:
- in patients with severe liver disease.
They have an increased risk of brain damage ( encephalopathy ). - as primary treatment for patients with delusions ( psychosis ).
- as the only treatment for depression or anxiety. The symptoms of depression may worsen. If you have ever felt so worthless that you have thought about taking your life, you must talk to your doctor as he may be able to help you.
Other medicines and Zolpidem Ratiopharm
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Other medicines can be affected by Zolpidem Ratiopharm. They can in turn affect how well Zolpidem Ratiopharm works. 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 types of medicines:
- medicines for certain mental problems (antipsychotics)
- medicines for sleep problems ( hypnotics )
- drugs that suppress or reduce anxiety
- muscle relaxants
- 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 (some antihistamines )
- medicines for the treatment of various fungal infections, e.g. itraconazole and ketoconazole.
The simultaneous use of zolpidem tartrate 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 tartrate simultaneously with opioid drugs, the dose and duration of treatment should 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 good to inform friends or relatives about the risks described above. Contact a doctor if you experience any of these symptoms.
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.
Medicines that enhance the activity of certain liver enzymes, e.g. rifampicin (for the treatment of tuberculosis ), may weaken the effect of Zolpidem Ratiopharm.
Zolpidem Ratiopharm with food, drink, and alcohol
You should not use alcohol during treatment as this can change and unpredictably enhance the effect of zolpidem. The ability to perform tasks that require increased concentration is further impaired due to this combination.
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.
Zolpidem Ratiopharm should not be used during pregnancy, especially not during the first 3 months, as there are insufficient data to evaluate the safe use of Zolpidem Ratiopharm during pregnancy and breastfeeding. Although Zolpidem Ratiopharm has not shown any malformations or harmful effects on the fetus in animal studies, safety in human pregnancy has not been confirmed.
If Zolpidem Ratiopharm is used for good medical reasons at the end of pregnancy or during childbirth, effects such as reduced body temperature, relaxed muscles, breathing difficulties, and withdrawal symptoms may occur in the newborn child due to physical dependence.
As zolpidem is excreted in small amounts in breast milk, Zolpidem Ratiopharm should not be used during breastfeeding.
Driving ability and use of machinery
Zolpidem Ratiopharm has a major impact on your ability to drive and use machines, for example so-called “sleep-driving”. The day after you take Zolpidem Ratiopharm (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 Ratiopharm, 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. 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 Ratiopharm contains lactose and sodium
Zolpidem Ratiopharm contains lactose. If you cannot tolerate certain sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, and can therefore be called almost “sodium-free”.
How to take Zolpidem Ratiopharm
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended dose is 10 mg of zolpidem tartrate per 24 hours. Some patients may be prescribed a lower dose. Zolpidem Ratiopharm 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. The medicine must be taken together with the liquid.
Elderly and frail patients
For elderly and weak patients, a dose of 5 mg zolpidem tartrate per 24 hours is recommended.
The doctor will decide if your daily dose may need to be increased.
Patients with impaired liver function
For patients with impaired liver function, a daily dose of 5 mg of zolpidem tartrate is recommended.
The doctor will decide if your daily dose may need to be increased.
Maximum dose
Never take more than 10 mg of zolpidem tartrate per 24 hours.
Use for children and adolescents
Zolpidem Ratiopharm must not be used by children and adolescents under the age of 18.
How long should you take Zolpidem Ratiopharm?
The treatment period should be as short as possible. Usually, it can last from a few days up to 2 weeks, but not more than 4 weeks.
The doctor will tell you when and how to end the treatment.
If you have taken too much Zolpidem Ratiopharm
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.
In case of overdose with Zolpidem Ratiopharm alone, a reduced level of consciousness, varying from extreme sleepiness to mild coma, has been reported.
If you forget to take Zolpidem Ratiopharm
If you forget to take a dose before going to bed but remember during the night, you can take the missed dose, provided you can still sleep undisturbed for 8 hours. If this is not possible, do not take the tablet until you go to bed the next evening.
Do not take a double dose to make up for a missed dose.
If you stop taking Zolpidem Ratiopharm
Do not stop taking this medicine suddenly. Difficulty sleeping may return in an intensified form, possibly together with mood swings, anxiety, and restlessness.
Withdrawal symptoms can include headaches, muscle pain, severe anxiety and tension, sleep disturbances, restlessness, confusion, and irritability. In severe cases, the feeling of perception of reality (derealization), the feeling of having lost one’s identity (depersonalization), numbness and tingling in the arms and legs, hypersensitivity to light, noise and physical touch, hallucinations or epileptic seizures may occur.
As the risk of withdrawal symptoms is greater after suddenly stopping treatment, the doctor will advise you to stop treatment by gradually reducing the dose (See section 2. “Dependence” and “Withdrawal symptoms”).
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects appear to be related to individual sensitivity and occur more often within an hour of taking the tablet if you do not go to bed or fall asleep immediately.
These side effects occur more often in older patients.
Side effects are:
| Common (may affect up to 1 in 10 users): | |
| Mental disorders: | Experiencing things that are not real (hallucinations), agitation, nightmares. |
| Central and peripheral nervous system: | Drowsiness during the following day, numb feelings, reduced reaction time, fatigue, headache, dizziness, difficulty remembering things ( amnesia ) which may be associated with inappropriate behavior, ataxia (loss of muscle coordination), and worsening insomnia. |
| Ears and organs of balance: | Dizziness with loss of balance ( vertigo ). |
| Gastrointestinal tract: | Diarrhea, nausea, vomiting, stomach ache. |
| General symptoms and/or symptoms at the site of administration: | Fatigue. |
Uncommon (may affect up to 1 in 100 users): | |
| Mental disorders: | Confusion, irritability. |
| Eyes: | Double vision. |
Frequency not known (cannot be estimated from available data): | |
| Mental disorders: | Restlessness, aggressiveness, delusions, anger, mental disorder ( psychosis ), sleepwalking, inappropriate behavior, and other behavioral disorders that may be associated with inappropriate behavior (see also section 2 “Warnings and precautions”). Such side effects occur more often in the elderly. Pre-existing depression may appear when using Zolpidem Ratiopharm or other sleep aids. Use of Zolpidem Ratiopharm for a longer period can lead to physical or psychological dependence. If you suddenly stop taking Zolpidem Ratiopharm, you may experience withdrawal symptoms (see section 2, “Warnings and precautions”). Misuse of zolpidem tartrate has been reported by drug abusers. Decreased sexual desire ( libido ). |
| Nerves: | Decreased level of consciousness |
| Skin: | Skin rash, hives, itching, excessive sweating. |
| Muscles, bones, and connective tissue: | Muscle weakness. |
| General symptoms and/or symptoms at the site of administration: | Abnormal posture when walking, drug tolerance, falls (mainly elderly patients and when Zolpidem Ratiopharm is not taken as prescribed ). |
| Liver: | Elevated liver values. |
| The immune system: | Sudden swelling of the lips, cheeks, eyelids, tongue, or throat. |
How to store Zolpidem Ratiopharm
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister pack after Ex.date/EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicine that is no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance in Zolpidem Ratiopharm 5 mg film-coated tablets is 5 mg zolpidem tartrate.
The active substance in Zolpidem Ratiopharm 10 mg film-coated tablets is 10 mg zolpidem tartrate.
Other ingredients are the
the core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, and hypromellose.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (dye E 171).
Appearance and package sizes of the medicine
Zolpidem Ratiopharm 5 mg film-coated tablets are white, oblong, biconvex, and marked with “ZIM” on one side and “5” on the other side.
Zolpidem Ratiopharm 10 mg film-coated tablets are white, oblong, biconvex with a score and marked “ZIM” and “10” on one side. The tablet can be divided into two equal doses.
The tablets are packed in blister packs which are packed in a carton with 4, 5, 7, 10, 14, 15, 20, 28, 30, 50, 100, or 500 film-coated tablets.
Zolpidem Ratiopharm is also available in tablet containers with 30, 100, or 500 tablets sealed with a child-resistant closure.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Manufacturer:
Merckle GmbH, Blaubeuren, Germany