Active ingredient
- zolpidem tartrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 17780/0018, PL 17780/0017.
Zolpidem Tartrate 5mg & 10mg Tablets
PATIENT INFORMATION LEAFLET
ZOLPIDEM 5MG OR 10MG TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 5mg or 10mg Tablets (called zolpidem throughout this leaflet). Zolpidem contains a medicine called zolpidem tartrate. This 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:
Your doctor will identify your sleep problem wherever possible and the underlying factors before prescribing this medicine for you. The failure of your sleep problems to stop after a 7-14 day course of treatment may indicate you have an underlying disorder, your doctor will assess you at regular intervals.
Zolpidem is used for short-term treatment of insomnia in adults. Do not use long-term. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment. Ask your doctor for advice if you are unsure.
2. What you need to know before you take zolpidem
Do not take zolpidem if:
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking zolpidem.
Warnings and precautions
Talk to your doctor or pharmacist before taking zolpidem if:
Use of Zolpidem may lead to the development of abuse and/or physical and psychological dependence.
The risk of dependence is greater when zolpidem is used for longer than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substance or drug abuse. Tell your healthcare provider if you have ever had a mental disorder or have abused or have been dependent on alcohol, substance or drugs.
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 caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.
Zolpidem can cause drowsiness and decrease your level of alertness. This could cause you to fall, sometimes leading to severe injuries.
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:
Take the single intake immediately at bedtime.
Do not take another dose during the same night.
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.
Zolpidem may increase the effect 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:
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, ciprofloxacin or St. John’s Wort (a herbal medicine) used for mood swings and depression.
Risks from concomitant use with opioids
Concomitant use of zolpidem and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe zolpidem together with opioids the dosage and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign and symptoms stated above. Contact your doctor when experiencing such symptoms.
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:
The following medicines can make zolpidem work less well:
Zolpidem with alcohol
Do not drink alcohol while you are taking 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 and breast-feeding
Pregnancy
Use of this medicine is not recommended during pregnancy.
If you discover that you are pregnant or are planning to have a baby, consult your doctor right away to re-assess the need for treatment.
A large amount of data has not shown evidence of malformations with benzodiazepines. However, some epidemiological studies have shown a potentially increased risk of cleft lip and palate in newborn babies compared to that in the general population.
Cleft lip and palate (sometimes called “harelip”) is a deformation at birth caused by incomplete fusion of the palate and upper lip.
Reduced fetal movement and fetal heart rate variability may occur after taking zolpidem during the second and/or third trimester of pregnancy.
If taken at the end of pregnancy muscle weakness (hypotonia), a drop in body temperature (hypothermia), difficulty feeding (problems suckling causing poor weight gain) and breathing problems (respiratory depression) may occur in the newborn.
If taken regularly in late pregnancy, your baby may get withdrawal symptoms. In this case the newborn should be closely monitored during the postnatal period.
Breast-feeding
Do not take zolpidem if you are breast-feeding or planning to breast-feed. This is because small amounts may pass into mothers’ milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
On the day after taking zolpidem, do not drive or use machinery or tools if you feel sleepy, dizzy or confused. Zolpidem has a major influence on the ability to drive and use machines such as ‘sleep driving’. On the day after taking zolpidem (as with other hypnotic medicines), you should be aware that:
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 as it can increase the above listed effects.
Zolpidem contains lactose
If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before having this medicine.
3. How to take zolpidem
Always take zolpidem exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
How much to take
Adults
Elderly
Patients with liver problems
Children and adolescents
Do not give this medicine to children under 18 years old.
Blood Tests
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:
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 effect’. If this happens you may get some of the effects listed below.
See a doctor straight away if you get any of the following effects:
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:
Tell your doctor as soon as possible if you have any of the following side effects:
Common side effects (may affect less than 1 in 10 people)
Uncommon side effects (may affect less than 1 in 100 people)
Rare side effects (may affect less than 1 in 1,000 people)
Sleep-driving and other sleep-related behaviour
There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleeping medicine. This includes sleep-driving, sleepwalking, preparing and eating food, 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 side effects (may affect less than 1 in 10 people)
Uncommon side effects (may affect less than 1 in 100 people)
Rare side effects (may affect less than 1 in 1,000 people)
Very rare side effects (affects less than 1 in 10,000 people)
Not known (frequency cannot be estimated from available data)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store zolpidem
Keep this medicine out of the sight and reach of children.
Do not use zolpidem after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in a dry place below 30°C in the original packaging.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Zolpidem 5mg and 10mg Tablets contain
Each 5mg tablet contains 5mg of zolpidem tartrate as the active substance.
Each 10mg tablet contains 10mg zolpidem tartrate as the active substance.
The other ingredients of Zolpidem 5mg and 10mg Tablets are lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycollate, magnesium stearate, titanium dioxide (E171), macrogol 400.
What Zolpidem 5mg and 10mg Tablets look like and contents of the pack
Zolpidem 5mg Tablets are round, white to off-white, film-coated tablets.
Zolpidem 10mg Tablets are oblong, white to off-white, film-coated tablets, with a score line and SN10 on one side.
Zolpidem 5mg Tablets are supplied in cartons of 28 tablets.
Zolpidem 10mg Tablets are supplied in cartons of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer of Zolpidem 5mg Tablets
Manufacturer of Zolpidem 10mg Tablets
This leaflet was last revised in August 2020
© 2020, Zentiva.
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