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STILNOCT 10MG FILM-COATED TABLETS

Active substance(s): ZOLPIDEM TARTRATE / ZOLPIDEM TARTRATE / ZOLPIDEM TARTRATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

2. Before you take Stilnoct

Stilnoct 10mg Film-coated Tablets

Do not take this medicine and tell your
doctor if:
X You are allergic (hypersensitive) to zolpidem
tartrate or any of the other ingredients of
Stilnoct (listed in section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
X Your lungs do not work properly (respiratory
failure)
X You have severe liver problems
X You have a problem where you stop breathing
for short periods at night (sleep apnoea)
X You have a problem that causes severe muscle
weakness (myasthenia gravis)
X You have been told by a doctor that you have
a mental illness (psychosis)
X You are under the age of 18
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 Stilnoct.

zolpidem tartrate
Is this leaflet is hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you start
taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This 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.
• If 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. What Stilnoct is and what it is used for
2. Before you take Stilnoct
3. How to take Stilnoct
4. Possible side effects
5. How to store Stilnoct
6. Further information

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1. What Stilnoct is and what it is
used for
The name of your medicine is Stilnoct 10mg FilmCoated Tablets (called Stilnoct in this leaflet).
Stilnoct 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.
Stilnoct 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:
• Difficulty falling asleep
• Waking in the middle of the night
• Waking too early
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.
Stilnoct is not meant to be used every day for long
periods of time. Ask your doctor for advice if you
are unsure.

Take special care with Stilnoct
Check with your doctor or pharmacist before
taking your medicine if:
▲ You have a history of alcohol or drug abuse
▲ You have liver problems
▲ You have depression or have had another
mental illness in the past
▲ You have recently taken Stilnoct or other
similar medicines for more than four weeks
▲ You are elderly
Stilnoct 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 Stilnoct.
Next-day psychomotor impairment (see also
Driving and using machines)
The day after taking Stilnoct, 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
• You take a higher dose than the recommended
dose
• You take Stilnoct while you are already taking
other central nervous system depressants or
another medicine that increases Stilnoct in
your blood, or while drinking alcohol, or while
taking illicit substances
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SENS DE DEROULEMENT
RECTO
(Intérieur bobine)

1

Take the single intake immediately at bedtime.
Do not take another dose during the same night.

Stilnoct. Alcohol can increase the effects of Stilnoct
and make you sleep very deeply so that you do not
breathe properly or have difficulty waking.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if
you are pregnant, might become pregnant, or
think you may be pregnant. Taking Stilnoct
during pregnancy may harm your baby.
You should not breast-feed if you are taking
Stilnoct. This is because small amounts may pass
into mother’s milk.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
Stilnoct has major influence on the ability to
drive and use machines such as “sleep driving”.
On the day after taking Stilnoct (as with 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 Stilnoct 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 Stilnoct as it can
increase the above listed effects.
Important information about some of the
ingredients of Stilnoct
Stilnoct contains:
• Lactose. This is a type of sugar. If you have
been told by your doctor that you cannot
tolerate some sugars (have an intolerance to
some sugars), talk to your doctor before taking
this medicine.
3. How to take Stilnoct

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Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Stilnoct can affect the
way some other medicines work. Also some
medicines can affect the way Stilnoct works.
Tell your doctor if you are taking any of the
following medicines:
Stilnoct may increase the effect of the following
medicines:
While taking Stilnoct 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 depression
• Medicines for moderate to severe pain
(narcotic analgesics)
• Medicines for epilepsy
• Medicines used for anaesthesia
• Medicines for hay fever, rashes or other
allergies that can make you sleepy (sedative
antihistamines)
While taking Stilnoct with antidepressants
including bupropion, desipramine, fluoxetine,
sertraline and venlafaxine, you may see things
that are not real (hallucinations).
It is not recommended to take Stilnoct with
fluvoxamine, ciprofloxacin or St John's Wort (a
herbal medicine) used for mood swings and
depression.
The following medicines can increase the
chance of you getting side effects when taken
with Stilnoct. To make this less likely, your
doctor may decide to lower your dose of
Stilnoct:
• Some antibiotics such as clarithromycin or
erythromycin
• Some medicines for fungal infections such as
ketoconazole and itraconazole
• Ritonavir (a protease inhibitor) – for HIV
infections
The following medicines can make Stilnoct
work less well:
• Some medicines for epilepsy such as
carbamazepine, phenobarbital or phenytoin
• Rifampicin (an antibiotic) - for infections

Taking Stilnoct with food and drink

• Do not drink alcohol while you are taking

2

Always take Stilnoct exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablet whole with a drink of water
• The recommended dose per 24 hours is 10mg
of Stilnoct. A lower dose may be prescribed to
some patients.
• Stilnoct 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.
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• Do not exceed 10mg per 24 hours.
• The usual length of treatment is 2 days to 4

In rare cases fits (seizures) may also occur.
4. Possible side effects

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weeks.
Adults
The usual dose is one Stilnoct tablet (10mg) just
before bedtime.
Elderly
The usual dose is half a tablet (5mg) just before
bedtime.
Patients with liver problems
The usual starting dose is half a tablet (5mg) just
before bedtime. Your doctor may decide to increase
this to one tablet (10mg) if it is safe to do so.
Children and adolescents
Stilnoct should not be used in people under 18
years old.
If you take more Stilnoct than you should
If you take more Stilnoct 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 Stilnoct can be very dangerous.
The following effects may happen:
• Feeling drowsy, confused, sleeping deeply and
possibly falling into a fatal coma.
If you forget to take Stilnoct
Stilnoct 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 Stilnoct
Keep taking Stilnoct until your doctor tells you to
stop. Do not stop taking Stilnoct 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 Stilnoct 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:
• Feeling anxious, restless, irritable or confused
• Headache
• Faster heartbeat or uneven heartbeat
(palpitations)
• Nightmares, seeing or hearing things that are
not real (hallucinations)
• Being more sensitive to light, noise and touch
than normal
• Relaxed grip on reality
• Feeling distant from your body or feeling
‘puppet-like’

• Numbness and tingling in your hands and feet
• Aching muscles
• Stomach problems
• Sleep problems come back worse than before

3

Like all medicines, Stilnoct can cause side effects,
although not everybody gets them.
Stop taking Stilnoct 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 (affects less than 1 in 10 people)
• Poor memory while taking Stilnoct (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 Stilnoct, 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 (affects less than 1 in 100 people)
• 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 sleeping
medicine. This includes sleep-driving, sleep
walking, 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 (affects less than 1 in 10 people)
• Diarrhoea
• Feeling sick (nausea) or being sick (vomiting)
• Abdominal pain
• Respiratory infection
• Headache
• Feeling tired or agitated
• Nightmares
• A feeling of being out of touch with reality and
being unable to think or judge clearly (psychosis)
• Feeling dizzy
Turn
• Feeling drowsy or sleepy
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• Back pain

By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Stilnoct

Uncommon (affects less than 1 in 100 people)
• Feeling confused or irritable
• Unusual skin sensations such as numbness,
tingling, pricking, burning or creeping on the
skin (paraesthesia)
• Tremor
• Blurred vision
• Changes in appetite or behaviour concerning
appetite
• Muscle pain
• Muscle spasms
Very rare (affects less than 1 in 10,000 people)
• Any changes of vision, in particular loss of
vision
Frequency unknown
• Itching skin or skin rash
• Excessive sweating
• Slower breathing (respiratory depression)
• Weak muscles
• Feeling restless, aggressive, angry or showing
unusual behaviour
• Depression
• Feeling overly happy/confident (euphoric)
• Thinking things that are not true (delusions)
• Changes in sex drive (libido)
• Changes in the amount of liver enzymes –
shown up in the results of blood tests
• You have discolouration of the skin or eyes,
pain in the abdomen (stomach) or a bloated
feeling, severe itching, pale or bloody stools,
extreme weakness, nausea or loss of appetite.
This could be caused by an infection or injury
to the liver
• An illness where removal of bile from the
liver is blocked (cholestasis). Signs include
jaundice, rash or fever and the colour of your
water (urine) becomes darker
• Lack of concentration
• Speech problems
• Changes in the way you walk
• Stilnoct having less effect than normal
• Becoming dependent on Stilnoct
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.

Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Stilnoct after the expiry date which is
stated on the carton or blister after EXP. 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

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What Stilnoct contains
• Each tablet of Stilnoct contains 10mg of the
active substance zolpidem tartrate
• Other ingredients are lactose monohydrate,
microcrystalline cellulose, hypromellose,
titanium dioxide (E171), sodium starch glycollate,
magnesium stearate and macrogol 400.
What Stilnoct looks like and contents of the pack
Stilnoct is a white to off-white, film-coated,
oblong (rectangle) shaped tablet with a scored
and engraved ‘SN 10’ on one side contained
within clear PVC/ foil blisters in cartons
containing 4 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
Delpharm Dijon, 6, Blvd. De L’Europe,
21800 Quétigny, France
This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised in: May 2017
© Sanofi, 1993-2017

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Expand Transcript

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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