Zolpidem 10mg Film-Coated Tablets
Zolpidem 5 mg film-coated tablet
Zolpidem 10 mg film-coated tablet
zolpidem tartrate
Package leaflet: Information for the patient
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Zolpidem is and what it is used for
2. What you need to know before you take Zolpidem
3. How to take Zolpidem
4. Possible side effects
5. How to store Zolpidem
6. Contents of the pack and other information
1. What Zolpidem is and what it is used for
The name of your medicine is Zolpidem. The tablets come in two strengths: Zolpidem 5 mg tablets and Zolpidem 10 mg tablets. Zolpidem belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.
Zolpidem is used for temporary sleep problems in adults that are causing you severe distress or that are affecting your everyday life. This includes sleep problems in adults such as:
- Difficulty falling asleep
- Waking in the middle of the night
- Waking too early
Zolpidem is not meant to be used every day for long periods of time. Ask your doctor for advice if you are unsure.
2. What you need to know before you take Zolpidem Do not take Zolpidem 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, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- You have lung disease or breathing problems
- You have severe liver problems
- You have a problem where you stop breathing for short periods at night (sleep apnoea)
- You have a problem that causes severe muscle weakness (myasthenia gravis)
- You have been told by your doctor that you have a mental illness (psychosis)
Zolpidem is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group.
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 if:
- You have a history of alcohol or drug abuse
- You have liver problems
- You have depression or have had another mental illness in the past
- You have recently taken Zolpidem or other similar medicines for more than four weeks
- You are elderly
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Zolpidem.
Next-day psychomotor impairment (see also Driving and using machines)
The day after taking Zolpidem, the risk of psychomotor impairment, including impaired driving ability may be increased if:
- You take this medicine less than 8 hours before performing activities that require your alertness
- You take a higher dose than the recommended dose
- You take zolpidem while you are already taking another central nervous system depressants or another medicines that increase zolpidem in your blood, or while drinking alcohol, or while taking illicit substances
Take the single intake immediately at bedtime.
Do not take another dose during the same night If after a few weeks you notice that the tablets are not working as well as they did when you first started taking them, you should go and see your doctor as an adjustment to your dosage may be required.
When taking this medicine there is risk of dependence (a need to keep taking the medicine). The risk increases with the dose and length of treatment period. The risk is greater if you had a history of alcohol or drug abuse.
When stopping this medicine you may experience side effects called withdrawal symptoms or experience a condition called rebound insomnia, see section 3 (If you stop taking Zolpidem).
Other medicines and Zolpidem
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Zolpidem can affect the way some other medicines work. Also some medicines can affect the way Zolpidem works.
Tell your doctor if you are taking any of the following medicines:
While taking zolpidem with the following medicines, drowsiness and next-day psychomotor impairment effects, including impaired driving ability, may be increased.
- Medicines for some mental health problems (antipsychotics)
- Medicines for sleep problems (hypnotics)
- Medicines to calm or reduce anxiety
- Medicines for depressions
- Medicines for moderate to severe pain (narcotic analgesics)
- Medicines for epilepsy
- Medicines used for anesthesia
- Medicines for hay fever, rashes or other allergies that can make you sleepy (sedatives antihistamines)
While taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not real (hallucinations)
It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
The following medicines can increase the chance of you getting side effects when taken with Zolpidem. To make this less likely, your doctor may decide to lower your dose of Zolpidem:
- Some antibiotics such as clarithromycin or erythromycin
- Some medicines for fungal infections such as ketaconazole and itraconazole
- Ritonavir (a protease inhibitor) - for HIV infections
The following medicines can make Zolpidem work less well:
- Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin
- Rifampicin (an antibiotic) - for infections
- St John’s Wort (a herbal medicine) - for mood swings and depression.
Zolpidem with food, drink and alcohol Do not drink alcohol while you are being treated with Zolpidem. Alcohol can increase the effects of Zolpidem and make you sleep very deeply so that you do not breathe properly or have difficulty waking.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking Zolpidem during pregnancy may harm your baby.
You should not breast feed if you are taking Zolpidem. This is because small amounts may pass into mother’s milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding
Driving and using machines
Zolpidem has major influence on the ability to drive and use machines such as “sleep driving”.
On the day after taking Zolpidem, (as other hypnotic medicines), you should be aware that:
- You may feel drowsy, sleepy, dizzy or confused.
- Your quick decision-making may be longer
- Your vision may be blurred or double
- You may be less alert
A period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights to minimize the above listed effects.
Do not drink alcohol or take other psychoactive substances while you are taking Zolpidem tartrate, as it can increase the above listed effects.
Zolpidem contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Zolpidem
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose per 24 hours is 10 mg of Zolpidem. A lower dose may be prescribed to some patients. Zolpidem should be taken:
- as a single intake,
- just before bedtime
- by mouth, with a drink of water
Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require your alertness. Do not exceed 10 mg per 24 hours. The usual length of treatment is 2 days to 4 weeks.
Adults
The usual dose is one 10 mg zolpidem tablet just before bedtime.
ALKALOID
Older people or debilitated patients
The usual dose is one 5 mg zolpidem tablet just before bedtime. Patients with liver problems
The usual starting dose is one 5 mg Zolpidem tablet just before bedtime. Your doctor may decide to increase this to one 10 mg Zolpidem tablet if it is safe to do so.
Use in children and adolescents
Zolpidem should not be used in people under 18 years old.
If you take more Zolpidem than you should
If you take more Zolpidem than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Taking too much Zolpidem can be very dangerous. The following effects may happen:
Feeling drowsy, confused, sleeping deeply and possibly falling into a fatal coma
Besides visual disturbances, twisting and repetitive movements or abnormal posture due to involuntary muscle contractions and spasm, movement disorders and paradoxical reactions (restlessness, hallucinations) may occur.
If you forget to take Zolpidem
Zolpidem must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Zolpidem
Keep taking Zolpidem until your doctor tells you to stop. Do not stop taking Zolpidem suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time.
If you stop taking Zolpidem suddenly, your sleep problems may come back and you may get a ‘withdrawal effects’ such as: headache, muscle pain, anxiety, tension, restless, mood changes, confusion, irritability and sleep disturbances. In rare cases fits (seizures) may also occur.
In severe cases other effects can include derealisation or depersonalization (feeling ‘divorced’ from one’s own identity and sense of reality), pins and needles in the limbs, hypersensitivity to light, sound and touch, hallucinations or epileptic seizures.
You may also experience a condition called rebound insomnia when stopping this medicine. This is an inability to sleep which may be worse than the insomnia you had before you started treatment. You may also experience mood changes, anxiety and restlessness.
The risk of withdrawal symptoms and rebound sleeplessness is higher after abrupt discontinuation of treatment, your doctor will advise you to terminate treatment by gradual reduction in the dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Zolpidem and see a doctor or go to a hospital straight away if:
- You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Tell your doctor as soon as possible if you have any of the following side effects:
Common (may affect up to 1 in 10 people)
- Poor memory while taking Zolpidem (amnesia) and strange behaviour during this time. This is more likely to affect you in the few hours after you take this medicine. By having 8 hours’ sleep after taking Zolpidem, this is less likely to cause you a problem.
- Sleeping problems that get worse after taking this medicine
- Seeing or hearing things that are not real (hallucinations) Uncommon (may affect up to 1 in 100 people)
- Blurred eyesight or ‘seeing double’
Not known: frequency cannot be estimated from the available data
- Being less aware of your environment
- Falling, especially in the elderly
Sleep-Driving and other strange behavior
There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine.
This includes sleep-driving, sleep walking and having sex. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common (may affect up to 1 in 10 people)
- Diarrhoea
- Headache
- Feeling tired or agitated
- Nightmares
Uncommon (may affect up to 1 in 100 people)
- Feeling confused or irritable
Not known: frequency cannot be estimated from the available data
- Itching skin or skin rash
- Weak muscles
- Feeling restless, aggressive, angry or showing unusual behaviour
- Thinking things that are not true (delusions)
- Changes in sex drive (libido)
- Change in the amount of liver enzymes - shown up in the results of blood tests
- Changes in the way you walk
- Zolpidem having less effect than normal
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zolpidem
This medicinal product does not require any special storage conditions when stored in original package.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Zolpidem tablets contain
- The active substance is zolpidem tartrate.
Zolpidem 5 mg: Each tablet contains: 5 mg zolpidem tartrate, equivalent to 4.019 mg zolpidem.
Zolpidem 10 mg: Each tablet contains 10 mg zolpidem tartrate, equivalent to 8.038 mg zolpidem.
- The other ingredients are: lactose, monohydrate; cellulose, microcrystalline; sodium starch glycolate type A; hypromellose; magnesium stearate; film coating 5 mg tablet: sepisprese dry 5212 rose - contains Hypromellose, Cellulose, microcrystalline, Titanium dioxide (E 171) and Red Iron oxide (E 172); film coating 10 mg tablet: opadry white Y-1-7000 - contains Hypromellose, Macrogol and Titanium dioxide (E 171).
What Zolpidem tablets look like and contents of the pack
Zolpidem 5 mg tablets
Red-pink, round, biconvex film-coated tablet without score line Zolpidem 10 mg tablets
White, round, biconvex film-coated tablet with score line on one side
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses Zolpidem 5 mg tablets are available in blister packs of 10 and 20 tablets.
Zolpidem 10 mg tablets are available in blister packs of 10, 20 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ALKALOID-INT d.o.o., Slandrova ulica 4, 1231 Ljubljana-
Crnuce, Slovenia
Tel.: 386 1 300 42 90
Fax: 386 1 300 42 91
e-mail:info@alkaloid.si
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria Adorma 5 mg; 10 mg film-coated tablets
Czech Republic Adorma 5 mg; 10 mg potahovane tablety Slovak Republic Adorma 5 mg; 10 mg filmom obalene tablety Slovenia Perluna 5 mg; 10 mg filmsko oblozene tablete
Romania Zadobra 5 mg; 10 mg comprimate filmate
UK Zolpidem 5 mg; 10 mg film-coated tablets
Zolpidem 5 mg film-coated tablets; PL 34088/0003 Zolpidem 10 mg film-coated tablets; PL 34088/0004
This leaflet was last revised 06/2015
Zolpidem_5 mg i 10 mg_UK_mock-up_juni 2015.indd 2 04-Jun-15 10:39:12 AM