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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 17780/0017, PL 17780/0018.
Zolpidem Tartrate 5mg and 10mg Tablets
Zolpidem 5mg Tablets
Zolpidem 10mg Tablets
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
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.
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.
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.
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.
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.
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.
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:
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
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.
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.
This medicine contains Lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before having this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’
Always take zolpidem exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
Elderly
Patients with liver problems
Do not give this medicine to children under 18 years old.
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:
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.
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:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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)
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.
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)
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.
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.
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 Tablets are lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycollate, magnesium stearate, titanium dioxide (E171) and macrogol 400.
The other ingredients of Zolpidem 10mg Tablets are lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycollate, magnesium stearate, macrogol, titanium dioxide (E171), talc and polyvinyl alcohol.
Zolpidem 5mg Tablets are round, white to off-white, film-coated tablets.
Zolpidem 10mg Tablets are oval, 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.
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This leaflet was last revised in August 2024
ZV/719 58