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ZOLPIDEM TARTRATE 10MG TABLETS

Active substance(s): ZOLPIDEM TARTRATE

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Zolpidem Tartrate 5mg and 10mg Tablets
 Please 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 Tartrate tablets are and what they are used for
2. What you need to know before you take Zolpidem Tartrate tablets
3. How to take Zolpidem Tartrate tablets
4. Possible side effects
5. How to store Zolpidem Tartrate tablets
6. Contents of the pack and other information
1. What Zolpidem Tartrate tablets are and what they are used for
Zolpidem Tartrate 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 Tartrate tablets
Do not take Zolpidem Tartrate 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 Tartrate 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 Tartrate tablets your
breathing may become less forceful
 have a history of mental illness, anxiety or psychotic illness. Zolpidem Tartrate 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 Tartrate 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.
Next-day psychomotor impairment (see also Driving and using machines)

The day after taking Zolpidem Tartrate tablets, 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
take a higher dose than the recommended dose
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.
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 reoccur in an enhanced
form, may happen 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 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 Tartrate tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Zolpidem Tartrate 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.
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)
Medicines inhibiting liver enzymes. Ask your doctor or pharmacist which medicines
have this effect.

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 effect of the following medicine may be increased by Zolpidem Tartrate tablets:
 muscle relaxants
The effect the following medicine may be decreased by Zolpidem Tartrate tablets:
 medicine used to treat tuberculosis (rifampicin).
Zolpidem Tartrate tablets with alcohol
Alcohol should not be consumed when taking Zolpidem Tartrate 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 Tartrate tablets should not be taken during pregnancy, especially in the first three
months. If for urgent medical reasons, Zolpidem Tartrate tablets are taken during late
pregnancy or during labour the baby may show withdrawal symptoms after birth because of
physical dependence.
Zolpidem will appear in breast milk in small amounts, therefore breast-feeding mothers
should not take this medicine.
Driving and using machines
Zolpidem Tartrate tablets has major influence on the ability to drive and use machines such as
“sleep driving”. On the day after taking Zolpidem Tartrate tablets (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 [Invented
Name], as it can increase the above listed effects
Zolpidem Tartrate tablets contains lactose
If you have been told you have an intolerance to some sugars, tell your doctor or pharmacist
before taking Zolpidem Tartrate tablets as this medicine contains lactose.
3 How to take Zolpidem Tartrate 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 dose per 24 hours is 10 mg of Zolpidem Tartrate tablets. A lower dose
may be prescribed to some patients. Zolpidem Tartrate tablets should be taken:
as a single intake,
just before bedtime
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 10mg per 24 hours.

- Elderly and debilitated patients
In elderly or debilitated a dose of 1/2 a tablet of Zolpidem Tartrate tablets 5mg
(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 1/2 a tablet of Zolpidem Tartrate tablets
5mg (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).
Maximum dose
A daily dose of 1 tablet of Zolpidem Tartrate tablets 10mg (corresponding to 10mg zolpidem
tartrate/day) should not be exceeded.

How long should you take Zolpidem Tartrate 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.
Use in children and adolescents
Zolpidem Tartrate tablets must not be used in children and adolescents of less than 18 years
of age
If you take more Zolpidem Tartrate 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 Tartrate 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 Tartrate 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 Tartrate 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.
Stop taking Zolpidem Tartrate 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: may affect up to 1 in 10 people

Poor memory while taking Zolpidem Tartrate 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 Tartrate tablets, 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

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 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: may affect up to 1 in 10 people

Diarrhoea

Feeling sick (nausea) or being sick (vomiting)

Abdominal pain

Respiratory infection

Headache

Feeling tired or agitated

Nightmares
Uncommon: may affect up to 1 in 100

Feeling confused or irritable
Not known: frequency cannot be estimated from the available data

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 Tartrate tablets having less effect than normal

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
By reporting side effects you can help provide more information on the safety of this
medicine.
5 How to store Zolpidem Tartrate 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 Tartrate tablets contains
The active substance 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, biconvex, white tablets .
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
Date of last Revision: May 2015

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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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