What Zolpidem Orifarm is and what it is used for
Zolpidem Orifarm contains zolpidem, which is a fast-acting sleep aid belonging to the group of benzodiazepine-related medicines. The time you sleep becomes longer and the risk of you waking up during the night decreases.
Zolpidem Orifarm is used for the short-term treatment of insomnia in adults. Do not use it for a long time. The treatment should be as short as possible because the risk of addiction increases with the length of the treatment.
Zolpidem contained in Zolpidem Orifarm may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Zolpidem Orifarm
Do not take Zolpidem Orifarm:
- if you are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6).
- if you have severely impaired liver function.
- if you have severe breathing problems.
- if you have temporary pauses in breathing when you sleep ( sleep apnea ).
- if you suffer from the muscle disease myasthenia gravis (severe muscle weakness).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Zolpidem Orifarm.
Tell the doctor about:
- you have reduced kidney function.
- you have reduced liver function.
- you have chronic respiratory problems.
- you suffer from a mental illness.
- you suffer from depression or have suicidal thoughts.
- you abuse or have abused alcohol, drugs, or medicines.
Treatment with sleeping pills should be temporary. Contact your doctor if your sleep problems persist after 7-14 days of treatment. The sleeping problems may then have other causes.
After repeated use for a few weeks, the sleep-inducing effect may decrease.
Use of Zolpidem Orifarm can lead to abuse and physical and psychological dependence on the drug. The risk of developing dependence is greater when Zolpidem Orifarm is used for longer periods than 4 weeks, and in patients who have previously had mental illness and/or alcohol, medication, or drug abuse.
Tell your doctor if you have ever had a mental illness and/or have abused or been dependent on alcohol, medicines, or drugs.
Release ( rebound effect )
When treatment with a sleeping aid is finished, a transient syndrome can occur, where the sleep disturbances return in an aggravated form. It may be accompanied by other reactions such as mood changes, anxiety, and restlessness.
Memory disorders ( amnesia )
Memory disturbances may occur. These usually occur several hours after you take the medicine. To reduce the risk, you must ensure that you sleep undisturbed for 8 hours.
Psychic and “paradoxical” reactions
Reactions such as restlessness, worsening insomnia, agitation, irritability, aggressiveness, delusions, tantrums, nightmares, hallucinations, inappropriate behavior, sleepwalking, or other behavioral disturbances may occur during treatment. If this occurs, treatment with Zolpidem Orifarm must be discontinued. These reactions occur more often in the elderly.
Sleepwalking and similar behaviors
Sleepwalking and similar behaviors, such as driving or cooking and eating without remembering afterward, have been reported in patients taking zolpidem. The risk seems to increase if alcohol or other drugs that affect the brain have been consumed at the same time, as well as when the zolpidem dose has been higher than the recommended one.
Risk of falling
Because Zolpidem Orifarm i.a. can cause drowsiness, increases the risk of falls and thus serious injuries (see section 4).
Problems with coordination the following day (see also Driving ability and use of machines).
The day after taking Zolpidem Orifarm, 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.
Suicidal thoughts, suicide attempts, and suicide
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.
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.
Children and young people
Other medicines and Zolpidem Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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
- 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).
Simultaneous use of Zolpidem Orifarm 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 Orifarm 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.
You are not recommended to take zolpidem together with fluvoxamine or ciprofloxacin.
The treatment effect can be affected if you take Zolpidem Orifarm together with medicines containing rifampicin (for tuberculosis ) or certain medicines for fungal infections ( ketoconazole ).
The treatment effect can be affected if Zolpidem Orifarm is taken together with St. John’s wort.
Taking Zolpidem Orifarm with alcohol
Pregnancy, breastfeeding, and fertility
Use of Zolpidem Orifarm during pregnancy is not recommended. 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.
There is a risk that the baby will be affected if Zolpidem Orifarm is used during pregnancy. Some studies have shown that there may be an increased risk of cleft lip and palate in newborns. Reduced fetal movements and effects on the fetal heart rate may occur after taking Zolpidem Orifarm during the last six months of pregnancy.
If Zolpidem Orifarm 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.
Driving ability and use of machinery
Zolpidem Orifarm has a major impact on your ability to drive and use machines, for example so-called “sleep-driving”. The day after taking Zolpidem Orifarm (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 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 Orifarm, 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 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 Orifarm contains lactose
How to take Zolpidem Orifarm
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Zolpidem Orifarm is 10 mg per 24 hours. Some patients may be prescribed a lower dose. Zolpidem Orifarm should be taken:
- as a single dose
- in connection with bedtime. Do not take any additional dose on the same night.
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 patients with impaired general condition
The usual dose is 5 mg.
Patients with mild or moderate hepatic impairment
The usual starting dose is 5 mg.
The duration of the treatment should be as short as possible. Treatment should not exceed 4 weeks.
If you feel that the effect of Zolpidem Orifarm is too strong or too weak, contact your doctor or pharmacist.
Zolpidem Orifarm 10 mg tablet is scored on one side. The tablet can be divided into two equal doses.
Use for children and adolescents
If you have taken too much Zolpidem Orifarm
If you have ingested too much medicine, e.g. a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Zolpidem Orifarm
Do not take a double dose to make up for a missed dose. If you forget to take a dose immediately before going to bed but remember it during the night, you should only take the missed dose if you still have the opportunity to sleep 7-8 hours.
If you stop taking Zolpidem Orifarm
If the treatment is stopped suddenly, sleep problems may worsen. Withdrawal symptoms can occur, e.g. headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability.
If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Zolpidem Orifarm and contact your doctor immediately if you experience any of the following symptoms ( angioedema )
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
Other side effects that may occur:
Common (may affect up to 1 in 10 users):
- dizziness, drowsiness, headache, worsening insomnia, problems with memory that can also affect behavior, e.g. learning difficulties, difficulty planning, problems with attention, or problems with speech
- hallucinations, agitation, nightmares
- back pain
- stomach and intestinal problems such as diarrhea, nausea, vomiting, and stomach ache
Uncommon (may affect up to 1 in 100 users):
- confusion, confusion
- double vision
- restlessness, aggressiveness, and sleepwalking (see section 2 “Warnings and precautions” for further information)
- skin rash, itching, abnormal sweating
- elevated liver values
- muscle weakness.
Rare (may affect up to 1 in 1,000 users):
- reduced level of consciousness
- changes in sexual desire,
- unsteady gait falls (especially in elderly patients and when zolpidem is not taken as prescribed) (see section 2 “Warnings and precautions” for further information)
- liver damage.
Very rare (may affect up to 1 in 10,000 users):
- delusions, dependence (need to continue medication accompanied by unpleasant symptoms when treatment is suddenly discontinued).
Has been reported (occurring in an unknown number of users):
- anger, various changes in behavior, and tolerance (reduced effect of the sleep aid).
How to store Zolpidem Orifarm
Keep this medicine out of the sight and reach of children.
Store the blister card in the outer carton.
Use before the expiry date stated on the packaging 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
- The active substance is zolpidem tartrate 5 mg and 10 mg respectively.
- Other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E 171), talc, and macrogol.
Appearance and package sizes of the medicine
5 mg film-coated tablet: white or almost white, round, biconvex.
10 mg film-coated tablet: white or almost white, oval with a score, marked BL 10 on the other side. The tablet can be divided into two equal doses.
Blisters: 7, 10, 14, 20, 21, 28, 30, 35, 98, 100, and 105 tablets.
Orifarm Generics A/S
5260 Odense S
Orifarm Generics AB
102 17 Stockholm