STILNOX® - Consumer Medicine Information (CMI) - Sanofi

STILNOX ®<br />

zolpidem tartrate<br />

<strong>Consumer</strong> <strong>Medicine</strong> <strong>Information</strong> (<strong>CMI</strong>)<br />

WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH UNUSUAL AND POTENTIALLY DANGEROUS<br />

BEHAVIOURS WHILST APPARENTLY ASLEEP. THESE HAVE INCLUDED SLEEP WALKING, DRIVING<br />

MOTOR VEHICLES AND OTHER BIZARRE BEHAVIOURS. SOME MEDICINES MAY INTERACT WITH<br />

ZOLPIDEM AND PARTICULAR CAUTION IS NEEDED WITH OTHER DRUGS THAT MAY ALSO ACT ON<br />

THE BRAIN; BEFORE YOU TAKE ZOLPIDEM REFER TO THE "TAKING OTHER MEDICINES" SECTION<br />

BELOW OR ASK YOUR DOCTOR OR PHARMACIST. YOU MUST NOT DRINK ALCOHOL WHEN YOU TAKE<br />

ZOLPIDEM. DO NOT TAKE ZOLPIDEM FOR MORE THAN 4 WEEKS. IF YOUR SLEEP PROBLEMS<br />

CONTINUE, CONSULT YOUR DOCTOR.<br />

What is in this leaflet<br />

This leaflet answers some common<br />

questions about STILNOX.<br />

It does not contain all the available<br />

information. It does not take the<br />

place of talking to your doctor or<br />

pharmacist.<br />

All medicines have risks and<br />

benefits. Your doctor has weighed<br />

the risks of you taking this medicine<br />

against the benefits they expect it<br />

will have for you.<br />

If you have any concerns about<br />

taking this medicine, ask your<br />

doctor or pharmacist.<br />

Keep this leaflet with the medicine.<br />

You may need to read it again.<br />

What STILNOX is used<br />

for<br />

STILNOX is used to initiate and<br />

maintain sleep in those with sleeping<br />

difficulties, also called insomnia. It is<br />

not recommended for use for more<br />

than 4 weeks at a time.<br />

STILNOX has a different chemical<br />

structure to other sleeping tablets.<br />

STILNOX works by binding to<br />

special sites in the brain which<br />

produce sleep.<br />

Your doctor, however, may prescribe<br />

STILNOX for another purpose.<br />

Ask your doctor or pharmacist if<br />

you have any questions about why<br />

it has been prescribed for you.<br />

This medicine is only available with<br />

a doctor's prescription.<br />

Before you take it<br />

When you must not take it<br />

Do not take STILNOX if you have:<br />

• been drinking alcohol or you<br />

believe that you may have alcohol<br />

in your bloodstream<br />

• sleep apnoea (a condition where<br />

you temporarily stop breathing<br />

while you sleep)<br />

• myasthenia gravis (a condition in<br />

which the muscles become weak<br />

and tire easily)<br />

• severe liver problems<br />

• acute and/or severe lung<br />

problems<br />

Do not take STILNOX if you are<br />

allergic to it or any of the<br />

ingredients listed at the end of this<br />

leaflet.<br />

Some symptoms of an allergic<br />

reaction include skin rash, itching,<br />

shortness of breath or swelling of the<br />

face, lips or tongue, which may cause<br />

difficulty in swallowing or breathing.<br />

Do not give STILNOX to a child or<br />

adolescent.<br />

There is no experience with its use in<br />

children or adolescents under 18<br />

years of age.<br />

Do not take it if you are pregnant<br />

or intend to become pregnant.<br />

It may affect your developing baby if<br />

you take it during pregnancy. Your<br />

doctor will discuss the risks and<br />

benefits of taking it if you are<br />

pregnant.<br />

Do not take it if you are breastfeeding<br />

or planning to breast-feed.<br />

STILNOX passes into breast milk<br />

and there is a possibility your baby<br />

may be affected. Your doctor will<br />

discuss the risks and benefits of using<br />

it if you are breast-feeding or<br />

planning to breast-feed.<br />

Do not take it after the expiry date<br />

(EXP) printed on the pack.<br />

If you take it after the expiry date has<br />

passed, it may not work as well.<br />

Do not take it if the packaging is<br />

damaged or shows signs of<br />

tampering.<br />

Before you start to take it<br />

Tell your doctor if you have<br />

allergies to any of the ingredients<br />

listed at the end of this leaflet.<br />

STILNOX ® 1

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Tell your doctor if you are<br />

pregnant or intend to become<br />

pregnant.<br />

Like most medicines of this kind,<br />

STILNOX is not recommended to be<br />

used during pregnancy. Your doctor<br />

will discuss the risks and benefits of<br />

taking it if you are pregnant.<br />

Tell your doctor if you are breastfeeding<br />

or planning to breast-feed.<br />

STILNOX can pass into breast milk.<br />

Your doctor will discuss the risks and<br />

benefits of using it if you are breastfeeding<br />

or planning to breast-feed.<br />

Tell your doctor if you have any<br />

problems with your breathing or if<br />

you often snore while you are<br />

asleep.<br />

Tell your doctor if you have ever<br />

been addicted to alcohol or any<br />

drug or medicine or if you have<br />

ever suffered from a mental illness.<br />

If you have, you may be at risk of<br />

getting into a regular pattern or<br />

habit of taking STILNOX.<br />

Tell your doctor if you have or<br />

have had any medical conditions,<br />

especially the following:<br />

• problems with your liver, kidneys<br />

or lungs<br />

• epilepsy<br />

• depression<br />

• schizophrenia<br />

Tell your doctor if you plan to have<br />

surgery.<br />

If you have not told your doctor<br />

about any of the above, tell them<br />

before you take STILNOX.<br />

Taking other medicines<br />

Tell your doctor if you are taking<br />

any other medicines, including any<br />

that you buy without a<br />

prescription from your pharmacy,<br />

supermarket or health food store.<br />

Some medicines may interfere with<br />

STILNOX. These include:<br />

• medicines to treat depression,<br />

anxiety and mental illness<br />

• medicines to treat epilepsy<br />

• pain relievers<br />

• muscle relaxants<br />

• antihistamines<br />

• rifampicin, a medicine to treat<br />

infections<br />

• ketoconazole, a medicine to treat<br />

antifungal infections<br />

These medicines may be affected by<br />

STILNOX, or may affect how well it<br />

works. You may need to use different<br />

amounts of your medicine, or take<br />

different medicines. Your doctor will<br />

advise you.<br />

Your doctor or pharmacist has more<br />

information on medicines to be<br />

careful with or to avoid while taking<br />

STILNOX.<br />

How to take it<br />

How much to take<br />

STILNOX should only be taken<br />

when you are able to get a full night's<br />

sleep (7 to 8 hours) before you need<br />

to be active again.<br />

The usual adult dose of STILNOX is<br />

one tablet (10 mg).<br />

If you are over 65 years of age the<br />

dose is half a STILNOX tablet (5<br />

mg).<br />

If you have a liver problem, the usual<br />

recommended dose is half a<br />

STILNOX tablet (5 mg). If<br />

necessary, this can be increased to 10<br />

mg.<br />

Your doctor may have prescribed a<br />

different dose.<br />

Ask your doctor if you are unsure<br />

of the correct dose for you.<br />

They will tell you exactly how much<br />

to take.<br />

Follow the instructions they give<br />

you.<br />

If you take the wrong dose,<br />

STILNOX may not work as well. If<br />

you take too much your conciousness<br />

may be impaired (see 'Overdose'<br />

below).<br />

STILNOX should not be given to<br />

children or adolescents less than 18<br />

years of age.<br />

How to take it<br />

Swallow the tablet whole with a<br />

full glass of water, unless your<br />

doctor has told you take half a<br />

tablet.<br />

When to take it<br />

Take STILNOX immediately<br />

before you go to bed or while you<br />

are in bed.<br />

It helps put you to sleep quite<br />

quickly. If you take STILNOX on an<br />

empty stomach it may work more<br />

quickly.<br />

If you are not sure when to take it<br />

ask your doctor or pharmacist.<br />

How long to take it<br />

Usually, STILNOX or any other<br />

medicines to treat sleeping disorders<br />

should only be used for short periods<br />

(eg 2 to 4 weeks). Continuous long<br />

term use is not recommended unless<br />

advised by your doctor.<br />

Ask your doctor or pharmacist if<br />

you are not sure how long to take<br />

the medicine for.<br />

If you forget to take it<br />

If you forget to take the tablet<br />

before you go to bed, and you wake<br />

up late in the night or very early in<br />

the morning, do not take it.<br />

You may have trouble waking at<br />

your normal time.<br />

If you are not sure what to do, ask<br />

your doctor.<br />

If you take too much<br />

(overdose)<br />

Immediately telephone your<br />

doctor, or the Poisons <strong>Information</strong><br />

Centre (telephone Australia 13 11<br />

26), or go to Accident and<br />

Emergency at your nearest<br />

hospital, if you think you or<br />

anyone else may have taken too<br />

much STILNOX.<br />

Do this even if there are no signs of<br />

discomfort or poisoning.<br />

You may need urgent medical<br />

attention.<br />

STILNOX ® 2

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If you take too much STILNOX,<br />

your consciousness may be impaired,<br />

ranging from drowsiness to light<br />

coma.<br />

While you are taking it<br />

Things you must do<br />

Tell all the doctors, dentists and<br />

pharmacists who are treating you<br />

that you are taking STILNOX.<br />

If you are about to be started on<br />

any new medicine, tell your doctor<br />

and pharmacist that you are taking<br />

STILNOX.<br />

If you plan to have surgery that<br />

needs a general anaesthetic, tell<br />

your doctor or dentist that you are<br />

taking this medicine.<br />

If you become pregnant while you<br />

are taking this medicine, stop<br />

taking it and tell your doctor or<br />

pharmacist immediately.<br />

Things you must not do<br />

Do not take more than the<br />

recommended dose unless your<br />

doctor tells you to.<br />

This can increase the risk of side<br />

effects.<br />

Do not give this medicine to anyone<br />

else, even if they have the same<br />

condition as you.<br />

Do not use this medicine to treat<br />

any other complaints unless your<br />

doctor tells you to.<br />

Do not drink alcohol before or<br />

after taking this medicine.<br />

This can increase the risk of side<br />

effects.<br />

Things to be careful of<br />

Because STILNOX will make you<br />

sleepy, you should not operate<br />

dangerous machinery or drive<br />

motor vehicles for 8 hours after<br />

you take it. You should also be<br />

careful the next morning when you<br />

wake up.<br />

Make sure you know how you react<br />

to STILNOX before you drive a car<br />

or operate machinery. This is very<br />

important if you are taking other<br />

drugs that also make you drowsy.<br />

Be careful if you are over 65 and<br />

unwell or taking other medicines.<br />

You may be more sensitive to some<br />

of the side effects of STILNOX.<br />

Some patients may be particularly<br />

susceptible to the sedative effects of<br />

the medication, which may increase<br />

the possibility of a fall.<br />

You should not drink alcohol while<br />

you are taking STILNOX.<br />

The effects of alcohol could be made<br />

worse while taking STILNOX.<br />

Side effects<br />

All medicines have some unwanted<br />

side effects. Sometimes they are<br />

serious, but most of the time they are<br />

not. Your doctor or pharmacist has<br />

weighed the risks of using this<br />

medicine against the benefits they<br />

expect it will have for you.<br />

Do not be alarmed by this list of<br />

possible side effects.<br />

You may not experience any of them.<br />

Tell your doctor as soon as possible<br />

if you do not feel well while you are<br />

taking STILNOX.<br />

It helps most people with insomnia,<br />

but it may have unwanted side effects<br />

in some people.<br />

Tell your doctor if you notice any<br />

of the following and they worry<br />

you:<br />

• drowsiness<br />

• dizziness<br />

• headache<br />

• fatigue<br />

• worsened insomnia<br />

• nightmares<br />

• hallucinations<br />

• agitation<br />

• diarrhoea, nausea and vomiting<br />

• abdominal pain<br />

• muscle weakness<br />

• infections of the nose, throat and<br />

chest<br />

These are the most common side<br />

effects of this medicine.<br />

Less common adverse effects<br />

include:<br />

Unexpected changes in behaviour.<br />

These have included rage reactions,<br />

confusion and other forms of<br />

unwanted behaviour.<br />

Sleep walking, driving motor<br />

vehicles and other unusual, and on<br />

some occasions dangerous,<br />

behaviours whilst apparently asleep.<br />

These have also included preparing<br />

and eating food, making phone calls<br />

or having sexual intercourse. People<br />

experiencing these effects have had<br />

no memory of the events.<br />

Alcohol can increase the risk of sleep<br />

walking and other related behaviours.<br />

These side effects can also occur<br />

without the presence of alcohol.<br />

Although these side effects can occur<br />

at the usual recommended doses, the<br />

risk of these behaviours occurring<br />

may also be increased if you take<br />

more than the recommended dose.<br />

Some sleep medicines may cause<br />

short-term memory loss. When this<br />

occurs, a person may not remember<br />

what has happened for several hours<br />

after taking the medicine. This is<br />

usually not a problem since most<br />

people fall asleep after taking the<br />

medicine.<br />

Sleep medicines should in most<br />

cases, be used only for short periods<br />

of time. If your sleep problems<br />

continue, consult your doctor.<br />

Some medicines can cause<br />

dependence, especially when they are<br />

used regularly for longer than a few<br />

weeks. People who have been<br />

dependent on alcohol or other drugs<br />

in the past may have a higher chance<br />

of becoming addicted to sleep<br />

medicines. If you have been addicted<br />

to alcohol or drugs in the past, it is<br />

important to tell your doctor before<br />

starting STILNOX.<br />

STILNOX ® 3

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If any of the following happen, stop<br />

taking this medicine and tell your<br />

doctor immediately, or go to<br />

Accident and Emergency at your<br />

nearest hospital:<br />

• swelling of the face, lips, mouth<br />

or throat, which may cause<br />

difficultly in swallowing or<br />

breathing<br />

• hives<br />

• fainting<br />

These are very serious side effects. If<br />

you have them, you may have had a<br />

serious allergic reaction to<br />

STILNOX. You may need urgent<br />

medical attention or hospitalisation.<br />

These side effects are very rare.<br />

Tell your doctor or pharmacist if<br />

you notice anything else that is<br />

making you feel unwell.<br />

Other side effects not listed above<br />

may occur in some consumers.<br />

Do not be alarmed by this list of<br />

possible side effects.<br />

You may not experience any of them.<br />

Ask your doctor or pharmacist to<br />

answer any questions you may<br />

have.<br />

After taking it<br />

Sometimes when medicines are<br />

stopped suddenly, after being used<br />

for a long time, withdrawal<br />

symptoms may occur. Symptoms of<br />

withdrawal may include abdominal<br />

and muscle cramps, vomiting and<br />

sweating.<br />

In some cases your insomnia may<br />

appear worse for a short time; speak<br />

to your doctor if this occurs.<br />

Patients taking part in trials have not<br />

had any problems when they stopped<br />

taking STILNOX.<br />

However, let your doctor know if<br />

you have any problems when you<br />

stop taking STILNOX.<br />

If you have any queries about any<br />

aspect of your medicine, or any<br />

questions regarding the<br />

information in this leaflet, discuss<br />

them with your doctor or<br />

pharmacist.<br />

Storage<br />

Keep your tablets in the blister<br />

pack until it is time to take them.<br />

If you take the tablets out of the box<br />

or the blister pack they may not keep<br />

well.<br />

Keep the medicine in a cool, dry<br />

place where the temperature stays<br />

below 25°C.<br />

Do not store it or any other<br />

medicine in the bathroom, near a<br />

sink, or on a windowsill.<br />

Do not leave it in the car.<br />

Heat and damp can destroy some<br />

medicines.<br />

Keep it where children cannot<br />

reach it.<br />

A locked cupboard at least one-anda-half<br />

metres above the ground is a<br />

good place to store medicines.<br />

Disposal<br />

If your doctor tells you to stop<br />

taking the medicine or it has<br />

passed its expiry date, ask your<br />

pharmacist what to do with any<br />

that are left over.<br />

Return any unused medicine to<br />

your pharmacist.<br />

Product description<br />

What it looks like<br />

• STILNOX 10mg - white, oblong<br />

breakable tablet, marked "SN10"<br />

• STILNOX 10mg tablets are<br />

available in boxes of 7 and 14<br />

tablets.<br />

Ingredients<br />

Active Ingredient:<br />

• zolpidem 10mg<br />

Inactive Ingredients:<br />

• lactose<br />

• microcrystalline cellulose<br />

• hypromellose<br />

• sodium starch glycollate<br />

• magnesium stearate<br />

• titanium dioxide<br />

• macrogol 400<br />

STILNOX does not contain gluten.<br />

Manufacturer/Sponsor<br />

STILNOX is supplied in Australia<br />

by:<br />

sanofi-aventis australia pty ltd<br />

12-24 Talavera Road<br />

Macquarie Park NSW 2113<br />

This leaflet was prepared in June<br />

2012.<br />

Australian Register Number(s)<br />

10mg tablets: AUST R 69681<br />

® Registered Trademark<br />

STILNOX ® 4