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Active substance: ZOLPIDEM TARTRATE

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Zolpidem Tartrate 5mg and 10mg Tablets
Please read all of this leaflet carefully before you start to take this
•  eep this leaflet. You may need to read it again.
•  f you have any further questions, ask your pharmacist or doctor.
•  his medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
•  f any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.  hat Zolpidem tablets are and what they are used for
2.  efore you take Zolpidem tablets
3.  ow to take Zolpidem tablets
4.  ossible side effects
5.  ow to store Zolpidem tablets
6.  urther information
1.  hat 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. Before you take Zolpidem tablets
Do not take Zolpidem tablets and tell your doctor if you:
•  re allergic (hypersensitive) to zolpidem or any of the other ingredients in
the tablet (see section 6). An allergic reaction may include a rash, itching,
difficulty breathing or swelling of the face, lips, throat or tongue
•  ave severe liver problems
•  uffer from breathing problems whilst sleeping (Sleep Apnoea
•  uffer from severe muscle weakness (myasthenia gravis)
•  ave severe breathing problems
•  re under the age of 18 years.

tablets recur in an enhanced form, may occur on withdrawal. It may be
accompanied by other reactions including mood changes, anxiety and
•  mnesia - Zolpidem tablets can cause memory loss. To reduce this risk you
should ensure that you are able to have 7-8 hours uninterrupted sleep.
•  sychiatric and “paradoxical” reactions - Zolpidem 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken
any other medicine including medicines obtained without a prescription.
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
•  edicines to treat mental illness (antipsychotics)
•  edicines to treat depression
•  ther sleeping pills
•  edicines to treat anxiety and other tranquillizers
•  arcotics (strong pain killers) such as codeine, morphine. Feelings of
excitement (euphoria) may increase, which in turn increase the chance on
physical or mental dependence
•  edicines used to treat epilepsy
•  naesthetics (used during surgery)
•  ntihistamine medicines which cause sleepiness
•  edicines inhibiting liver enzymes such as itraconazole. Ask your doctor or
pharmacist which medicines have this effect.
The effect of the following medicine may be increased by Zolpidem tablets:
•  uscle relaxants

Check with your doctor or pharmacist before taking Zolpidem tablets if you:
•  re 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
•  ave any kidney or liver problems.
•  ave a history of breathing problems. Whilst taking Zolpidem tablets
your breathing may become less forceful
•  ave a history of mental illness, anxiety or psychotic illness. Zolpidem
tablets may unmask or worsen symptoms
•  uffer from or have a history of depression
•  ave 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.
Please tell your doctor if you have any of the conditions listed above.

The effect of the following medicine may be decreased by Zolpidem tablets:
•  edicine used to treat tuberculosis (rifampicin).

Other considerations
•  abituation - 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.
•  ependence - 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.
•  ithdrawal - treatment should be gradually withdrawn. A transient
syndrome whereby the symptoms that led to treatment with Zolpidem

Zolpidem will appear in breast milk in small amounts, therefore breastfeeding mothers should not take this medicine.


Taking Zolpidem with alcohol
Alcohol should not be consumed when taking Zolpidem tablets, as the
sedating effect may be increased.
Pregnancy and breast-feeding
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.

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.

Important information about some of the ingredients of Zolpidem
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
3. How to take Zolpidem tablets
Always take Zolpidem tablets exactly as your doctor has told you. You should
check with your doctor or pharmacist when you are not sure.
The tablet should be taken together with liquid immediately before going
to bed.
The usual dose is:
•  dults: 10mg immediately before going to bed. This dose must not be
•  lderly, frail or patients with liver disease: a lower dose of 5mg at night may
be used. This dose may be increased to 10mg by your doctor.
•  hildren & adolescents: Zolpidem tablets are not intended for patients
under 18 years of age.
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.
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
•  reatment 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
•  f 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, Zolpidem tablets can cause unwanted side effects,
although not everybody gets them.

Tell your doctor or pharmacist if any of the following side effects occur
or worsen:
Common (occur in less than 1 in 10 people) - drowsiness the following day,
numbed emotions, reduced alertness, confusion, fatigue, headache, double
vision, ‘spinning’ sensation co-ordination disturbances, muscle weakness.
Uncommon (occur in less than 1 in 100 people) - diarrhoea, feeling and
being sick, skin reactions, decreased libido.
Restlessness, agitation, irritability, aggressiveness, delusions (false beliefs),
rage, nightmares, depressions, hallucinations, psychoses, sleepwalking,
behavioural problems and memory loss. When these reactions occur, you
should tell your doctor and stop taking Zolpidem tablets. Psychological
dependence may occur, meaning you think that you cannot ever sleep
without taking Zolpidem tablets.
Use (even at therapeutic dosages) may lead to physical dependence, sudden
discontinuation of treatment may result in withdrawal effects and recurrence
of problems.
If any of the side effects get worse, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
5. How to store Zolpidem tablets
Keep out of the reach and sight of children.
No special storage conditions.
Do not use Zolpidem after the expiry date which is stated on the product
packaging. 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 dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further 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
The other ingredients are:
•  ore: lactose monohydrate, microcrystalline cellulose, sodium starch
glycollate type A, hydroxypropyl methylcellulose, magnesium stearate.
•  oating: hydroxypropyl methylcellulose, titanium dioxide (E171),
polyethylene glycol 400.
What Zolpidem looks like and contents of the pack
-  olpidem 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”.
-  olpidem 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.
-  ack size: 28.
Marketing authorization holder
EX32 8NS
Synthon Hispania S.L.
Poligono Las Salinas
08830 Sant Boi de Llobregat
Date of last Revision

If you experience the following rare, but very serious side effect, stop
taking Zolpidem tablets and tell your doctor immediately or contact the
casualty department at your nearest hospital:
•  n allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or
difficulty breathing or swallowing.


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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.