ZOLPIDEM TARTRATE 10MG TABLETS

Active substance: ZOLPIDEM TARTRATE

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Package Leaflet: Information for the User
Zolpidem Tartrate 5mg and 10mg Tablets
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 pharmacist or doctor.
• 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 tablets are and what they are used for
2. What you need to know before you take Zolpidem tablets
3. How to take Zolpidem tablets
4. Possible side effects
5. How to store Zolpidem tablets
6. Contents of the pack and other information
1. What Zolpidem tablets are and what they are used for
Zolpidem tablets are sleeping pills (hypnotics) which work by acting on the brain to cause
sleepiness.
They may be used for short term treatment of difficulty in sleeping which is severe, disabling
or causing great distress.
2 What you need to know before you take Zolpidem tablets
Do not take Zolpidem tablets if you:
• are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in
section 6). An allergic reaction may include a rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue
• have severe liver problems
• suffer from breathing problems whilst sleeping (Sleep Apnoea Syndrome)
• suffer from severe muscle weakness (myasthenia gravis)
• have severe breathing problems
• are under the age of 18 years.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Zolpidem tablets if you:
• are elderly or frail. If you get up at night, take care as there is an increased risk of falling
and consequently of hip fractures due to the muscle relaxant effect of the tablets
• have any kidney or liver problems.
• have a history of breathing problems. Whilst taking Zolpidem tablets your breathing
may become less forceful
• have a history of mental illness, anxiety or psychotic illness. Zolpidem tablets may
unmask or worsen symptoms
• suffer from or have a history of depression
• have or have ever had a history of or tendency to alcohol or drug abuse. The risk of
dependence to Zolpidem tablets (physical or mental effects produced by a compulsion to
keep taking the medicine) increases in these patients, and with dose and length of
treatment.
Other considerations

• Habituation – if after a few weeks you notice that the tablets are not working as well as
they did when first starting treatment, you should go and see your doctor as an adjustment
to your dosage may be required.
• Dependence – when taking this type of medicine there is a risk of dependence, which
increases with dose and length of treatment. There is a greater risk in patients with a
history of alcohol or drug abuse.
• Withdrawal – treatment should be gradually withdrawn. A transient syndrome whereby the
symptoms that led to treatment with Zolpidem Tartrate tablets recur in an enhanced form,
may occur on withdrawal. It may be accompanied by other reactions including mood
changes, anxiety and restlessness.
• Amnesia – Zolpidem Tartrate tablets can cause memory loss. To reduce this risk you
should ensure that you are able to have 7-8 hours uninterrupted sleep.
• Psychiatric and “paradoxical” reactions – Zolpidem Tartrate tablets can cause behavioural
side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false
beliefs), rages, nightmares, hallucinations, psychoses, sleepwalking, inappropriate
behaviour, increased insomnia and other adverse behavioural effects.
Other medicines and Zolpidem tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Zolpidem tablets may influence the effect and/or side effects of other medicines. If
you see another doctor or go into hospital, particularly if you are having an operation under
anaesthesia tell the doctor which medicines you use.
The following medicines may increase the sedating effect of Zolpidem tablets:
• medicines to treat mental illness (antipsychotics)
• medicines to treat depression
• other sleeping pills
• medicines to treat anxiety and other tranquillizers
• narcotics (strong pain killers) such as codeine, morphine. Feelings of excitement
(euphoria) may increase, which in turn increase the chance on physical or mental
dependence
• medicines used to treat epilepsy
• anaesthetics (used during surgery)
• antihistamine medicines which cause sleepiness
• medicines inhibiting liver enzymes. Ask your doctor or pharmacist which medicines have
this effect.
The effect of the following medicine may be increased by Zolpidem tablets:
• muscle relaxants
The effect of Zolpidem tablets may be decreased by the following medicine:
• medicine used to treat tuberculosis (rifampicin).
Zolpidem with food, drink and alcohol
Alcohol should not be consumed when taking Zolpidem tablets, as the sedating effect may be
increased.
Pregnancy and breast-feeding
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.
Zolpidem tablets should not be taken during pregnancy, especially in the first three months. If
for urgent medical reasons, Zolpidem tablets are taken during late pregnancy or during labour
the baby may show withdrawal symptoms after birth because of physical dependence.

If you are planning to become pregnant or suspect you may already be pregnant do not take
Zolpidem tablets and contact your doctor as soon as possible for advice. If you are taking
Zolpidem tablets and notice that you are pregnant, contact your doctor as soon as possible for
advice.
Zolpidem will appear in breast milk in small amounts, therefore breast-feeding mothers
should not take this medicine.
Driving and using machines
Zolpidem tablets may make you feel drowsy, cause loss of concentration or memory or
muscle weakness. This feeling may be even worse when you sleep for less than 7 to 8 hours
after taking your medication. If affected do not drive or operate machinery.
Zolpidem tablets contain lactose
If you have been told you have an intolerance to some sugars, tell your doctor or pharmacist
before taking Zolpidem tablets as this medicine contains lactose.
3 How to take Zolpidem tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The tablet should be taken together with liquid immediately before going to bed.
The recommended dose is:
Adults
The recommended daily dose for adults is 1 tablet of Zolpidem Tartrate tablets10mg
(corresponding to 10mg zolpidem tartrate/day).
- Elderly and debilitated patients
In elderly or debilitated a dose of 1/2 tablet of Zolpidem Tartrate tablets 10mg (corresponding
to 5mg zolpidem tartrate/day) is recommended. If the effect is insufficient and you tolerate
the medicine well, your doctor may decide to increase the dose to 1 tablet of Zolpidem
Tartrate tablets 10mg (corresponding to 10mg zolpidem tartrate/day).
- Patients with impaired liver function
In patients with impaired liver function a dose of one half of a tablet of Zolpidem Tartrate
tablets 10mg (corresponding to 5 mg zolpidem tartrate/day) is recommended. If the effect is
insufficient and you tolerate the medicine well, your doctor may decide to increase the dose to
1 tablet of Zolpidem Tartrate tablets 10mg (corresponding to 10mg zolpidem tartrate/day).
Maximum dose
A daily dose of 1 tablet of Zolpidem Tartrate tablets 10mg (corresponding to 10mg zolpidem
tartrate/day) should not be exceeded.
Children and adolescents
Zolpidem Tartrate tablets must not be used in children and adolescents of less than 18 years
of age.
How long should you take Zolpidem tablets
The duration of administration should be as short as possible. In general, it could be a few
days up to 2 weeks and not exceed 4 weeks the stepwise withdrawal phase included. Your
doctor will choose a withdrawal regime based on your individual needs.
Certain situations may require prolongation beyond the maximum time of treatment. Your
attending doctor will decide on that after renewed evaluation of your complaints.

If you take more Zolpidem tablets than you should
If you, (or someone else) swallow a lot of the tablets at the same time, or if you think a child
has swallowed any of the tablets, contact your nearest hospital casualty department or your
doctor immediately, do not go unaccompanied to seek medical help. If an overdose has been
taken you may become increasingly drowsy very quickly, with high doses probably leading to
a coma.
If you forget to take Zolpidem tablets
If you forget to take a dose immediately before going to bed but remember during the night,
only take the missed dose if you are still able to have 7-8 hours of uninterrupted sleep. If this
is not possible, take the next dose before bed time the next night. Do not take a double dose to
make up for a forgotten tablet. If you are worried ask your pharmacist or doctor for advice.
If you stop taking Zolpidem tablets
• Treatment should be gradually withdrawn as the symptoms you are treated for will return
more intense than before (rebound insomnia), also anxiety, restlessness and mood
changes may occur. These effects will disappear in time.
• If you have become physically dependent to Zolpidem tablets, sudden withdrawal of
treatment will lead to side effects such as headaches, muscle pain, anxiety, tension,
restlessness, confusion, irritability and sleeplessness. In severe cases other effects may
appear, such as hypersensitivity to light, noise and physical contact, abnormally acute
hearing and painful sensitivity to sound, hallucinations, numbness and tingling of the
extremities, derealisation (feeling the world around you is not real), depersonalisation
(feeling your mind is becoming separated from your body) or epileptic seizures (violent
fitting or shaking). These symptoms may also be experienced between doses, especially if
the dose is high.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon:
affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in 10,000
Not known:
frequency cannot be estimated from the available data.
Stop taking Zolpidem tablets 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:

Poor memory while taking Zolpidem tablets (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 7-8 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:

Blurred eyesight or 'seeing double'

Frequency unknown:

Being less aware of your environment

Falling, especially in the elderly
Sleep-Driving and other strange behaviour
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:

Diarrhoea

Feeling sick (nausea) or being sick (vomiting)

Abdominal pain

Respiratory infection

Headache

Feeling tired or agitated

Nightmares
Uncommon:

Feeling confused or irritable
Frequency unknown:

Itching skin or skin rash

Excessive sweating

Slower breathing (respiratory depression)

Weak muscles

Coordination problems (ataxia)

Abuse

Feeling restless, aggressive, angry or showing unusual behaviour

Depression

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

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5 How to store Zolpidem tablets
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 product packaging. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

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 tablets contain
The active substance (the ingredient that makes the medicine work) is zolpidem tartrate. Each
tablet contains either 5mg or 10mg of the active ingredient.
The other ingredients are:
• core: lactose monohydrate, microcrystalline cellulose, sodium starch glycollate type A,
hydroxypropyl methylcellulose, magnesium stearate
• coating: hydroxypropyl methylcellulose, titanium dioxide (E171), polyethylene glycol
400.
What Zolpidem looks like and contents of the pack
- Zolpidem Tartrate Actavis 5 mg, filmcoated tablets are oval, white tablets with a
breaking line. One side is imprinted “ZIM”, the other side is imprinted “5”.
- Zolpidem Tartrate Actavis 10 mg, filmcoated tablets are oval, white tablets with a
breaking line. One side is imprinted “ZIM”, the other side is imprinted “10”.
The tablets are packed in blisters inserted into a carton and in polyethylene containers
with a child- resistant closure.
- Pack size: 28
Marketing authorisation holder

Actavis, Barnstaple, EX32 8NS, UK
Manufacturer

Synthon Hispania S.L., Poligono Las Salinas, 08830 Sant Boi de Llobregat, Spain
This leaflet was last revised in January 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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