ZOLPIMIST®

WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH UNUSUAL AND POTENTIALLY DANGEROUS BEHAVIOURS WHILST APPARENTLY ASLEEP. THESE HAVE INCLUDED SLEEP WALKING, DRIVING MOTOR VEHICLES AND OTHER BIZARRE BEHAVIOURS. SOME MEDICINES MAY INTERACT WITH ZOLPIDEM AND PARTICULAR CAUTION IS NEEDED WITH OTHER DRUGS THAT MAY ALSO ACT ON THE BRAIN; BEFORE YOU TAKE ZOLPIDEM REFER TO THE “TAKING OTHER MEDICINES” SECTION BELOW OR ASK YOUR DOCTOR OR PHARMACIST. YOU MUST NOT DRINK ALCOHOL WHEN YOU TAKE ZOLPIDEM. DO NOT TAKE ZOLPIDEM FOR MORE THAN 4 WEEKS. IF YOUR SLEEP PROBLEMS CONTINUE, CONSULT YOUR DOCTOR.

ZOLPIMIST®

Active ingredient(s): Zolpidem tartrate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using ZOLPIMIST. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ZOLPIMIST.

Where to find information in this leaflet:

1. Why am I using ZOLPIMIST?
2. What should I know before I use ZOLPIMIST?
3. What if I am taking other medicines?
4. How do I use ZOLPIMIST?
5. What should I know while using ZOLPIMIST?
6. Are there any side effects?
7. Product details

1. Why am I using ZOLPIMIST?

ZOLPIMIST contains the active ingredient zolpidem tartrate. ZOLPIMIST is used to initiate and maintain sleep in those with sleeping difficulties, also called insomnia in patients over 18 years of age. It is not recommended for use for more than 4 weeks at a time.

ZOLPIMIST has a different chemical structure to other sleeping tablets. ZOLPIMIST works by binding to special sites in the brain which produce sleep.

Your doctor, however, may prescribe ZOLPIMIST for another purpose.

2. What should I know before I use ZOLPIMIST?

Warnings

Do not use ZOLPIMIST if:

• you are allergic to zolpidem tartrate, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• you have been drinking alcohol or you believe that you may have alcohol in your bloodstream
• you have sleep apnoea (a condition where you temporarily stop breathing while you sleep)
• you have myasthenia gravis (a condition in which the muscles become weak and tire easily)
• you have severe liver problems
• you have acute and/or severe lung problems
• you have previously experienced complex sleep behaviours after taking this medicine including sleepwalking, sleep-driving, and/or engaging in other activities while not fully awake.

Check with your doctor if you:

• have any problems with your breathing or if you often snore while you are asleep.
• have ever been addicted to alcohol or any drug or medicine or if you have ever suffered from a mental illness. If you have, you may be at risk of getting into a regular pattern or habit of taking ZOLPIMIST.
• have or had any medical conditions, especially the following: problems with your heart, liver, kidneys or lungs, epilepsy, depression, mental illness, for example, schizophrenia.
• plan to have surgery.
• have allergies to any of the ingredients listed at the end of this leaflet.
• take any medicines for any other condition.

Talk to your doctor or pharmacist if you have ever had a mental disorder or have abused or have been dependent on alcohol or drugs.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant, suspect that you are pregnant or intend to become pregnant.

Like most medicines of this kind, ZOLPIMIST is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of using it if you are pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

ZOLPIMIST can pass into breast milk and there is a possibility your baby may be affected. Your doctor will discuss the risks and benefits of using it if you are breastfeeding or planning to breast-feed.

Do not take it after the expiry date (EXP) printed on the pack.

Do not take it if the packaging is damaged or shows signs of tampering.

Children and adolescents

Do not give ZOLPIMIST to a child or adolescent under 18 years of age.

• There is no experience with its use in children or adolescents under 18 years of age.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins, or supplements that you buy without a prescription from your pharmacy, supermarket, or health food shop.

Some medicines may interfere with ZOLPIMIST and affect how it works.

Medicines that may increase the effect of ZOLPIMIST include:

• alcohol
• medicines to treat depression, anxiety, and mental illness
• medicine used to produce calmness or to help you sleep
• medicines to treat epilepsy
• pain relievers
• muscle relaxants
• antihistamines
• ciprofloxacin, a medicine to treat infections
• ketoconazole, a medicine to treat antifungal infections
• opioids

These medicines may increase drowsiness. This may affect your ability to drive a car or operate dangerous machinery. You may need to use different amounts of your medicine or take different medicines. Your doctor will advise you.

Medicines that may reduce the effect of ZOLPIMIST include:

• St John’s Wort (also known as Hypericum perforatum), a herbal remedy used to treat depression
• rifampicin, a medicine to treat infections

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ZOLPIMIST.

4. How do I use ZOLPIMIST?

How much to take

• The usual adult dose of ZOLPIMIST is two sprays (10 mg).
• If you are over 65 years of age the dose is one spray of ZOLPIMIST (5 mg).
• If you have a liver problem, the usual recommended dose is one spray of ZOLPIMIST (5 mg).
  Do not take ZOLPIMIST if you have a severe liver problem.
• Your doctor may have prescribed a different dose. The lowest effective daily dose should be used and must not exceed 10 mg (two sprays). Follow the instructions provided and use ZOLPIMIST until your doctor tells you to stop.
• If you take the wrong dose, ZOLPIMIST may not work as well.
• If you take too much your consciousness may be impaired (see ‘If you take too much ZOLPIMIST’ below).
• Ask your doctor if you are unsure of the correct dose for you. They will tell you exactly how much to take.

How long to take it

• Usually, ZOLPIMIST or any other medicines to treat sleeping disorders should only be used for short periods (e.g., 2 to 4 weeks). Continuous long-term use is not recommended unless advised by your doctor.
• Ask your doctor or pharmacist if you are not sure how long to take the medicine for.

When to use ZOLPIMIST

• Take ZOLPIMIST immediately before you go to bed or while you are in bed.
• ZOLPIMIST should only be taken when you are able to get a full night’s sleep (7 to 8 hours) before you need to be active again. It should be taken in one dose and not be re-administered during the same night.
• It helps put you to sleep quite quickly. If you take ZOLPIMIST on an empty stomach it may work more quickly.
• If you are not sure when to take it ask your doctor or pharmacist.

How to use ZOLPIMIST

Be sure to carefully read, understand and follow these instructions so that you use ZOLPIMIST the right way. Ask your doctor or pharmacist if you have any questions about how to use ZOLPIMIST.

Before you use ZOLPIMIST for the first time, you will need to prime the pump seven times (Steps 1-6).

If you have not used ZOLPIMIST for 14 days, you will need to prime the pump once (Steps 1-5 and then proceed to Step 11).

Otherwise go directly to Step 7.

To prime the pump

1. Line up the arrows on the child-resistant cap and base (see Figure 1).
2. Squeeze the cap at arrows (see Figure 2).
3. Pull the cap and base to separate (see Figure 3).
4. Remove the clear protective cap from the pump (see Figure 4).
5. Hold the container upright. Point the black spray opening in a safe direction away from your face and other people. Fully press down on the pump with your forefinger. Release the pump and let the pump return to the starting position.
6. Follow step 5 and press down on the pump 6 more times. You should see a fine spray. ZOLPIMIST is now ready to use. Now go directly to Step 11.
7. Taking a dose of ZOLPIMIST

• Take ZOLPIMIST exactly as prescribed. Do not take more ZOLPIMIST than prescribed for you. Your doctor will tell you whether to take 1 or 2 sprays of ZOLPIMIST.
• Take ZOLPIMIST right before you get into bed.
• Take ZOLPIMIST whilst you are standing or sitting and NOT when you are lying down.
• Do not take ZOLPIMIST unless you are able to stay in bed a full night (7-8 hours) before you must be active again.

Line up the arrows on the child-resistant cap and base (see Figure 1).

8. Squeeze the cap at arrows (see Figure 2).

9. Pull the cap and base to separate (see Figure 3).

10. Remove the clear protective cap from the pump (see Figure 4).

11. Hold the container upright with the black spray opening pointed directly into your mouth. Fully press down on the pump to make sure that a full dose of ZOLPIMIST is sprayed directly into your open mouth over your tongue (see Figure 5).

12. Let the pump return to the starting position. If your doctor prescribed only one spray of ZOLPIMIST (5 mg dose), go directly to Step 14.
13. If your doctor prescribed a second spray of ZOLPIMIST (10 mg dose), repeat Step 11.
14. Put the clear protective cap back over the pump at the top of the child-resistant base after each use (see Figure 6).

15. Snap the child-resistant cap back onto the base and rotate the child-resistant cap and the child-resistant base so that the arrows are not lined up (see Figure 7).

16. The child-resistant container should be thrown away when the 28 sprays have been used.

If you forget to use ZOLPIMIST

If you forget to use ZOLPIMIST before you go to bed, and you wake up late in the night or very early in the morning, do not take it.

You may have trouble waking at your normal time.

If you are not sure what to do, ask your doctor.

If you use too much ZOLPIMIST

If you think that you have used too much ZOLPIMIST, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much your consciousness may be impaired ranging from drowsiness to light coma.

5. What should I know while using ZOLPIMIST?

Things you should do

Tell all the doctors, dentists and pharmacists who are treating you that you are using ZOLPIMIST.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking ZOLPIMIST.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are using this medicine.

If you become pregnant or suspect that you are pregnant while you are taking this medicine, stop taking it and tell your doctor or pharmacist immediately.

ZOLPIMIST spray should be kept away from your eyes

Call your doctor straight away if you:

• have any of the serious side effects listed in section 6

Remind any doctor, dentist, or pharmacist you visit that you are using ZOLPIMIST.

Things you should not do

• Do not take more than the recommended dose unless your doctor tells you to. This can increase the risk of side effects.
• Do not inhale ZOLPIMIST
• Do not use ZOLPIMIST with or immediately after a meal
• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not use this medicine to treat any other complaints unless your doctor tells you to.
• Do not drink alcohol before or after taking this medicine. This can increase the risk of side effects or the effects of alcohol could be made worse while taking ZOLPIMIST.

Things to be careful of:

• if you are over 65 and unwell or taking other medicines. You may be more sensitive to some of the side effects of ZOLPIMIST. Some patients may be particularly susceptible to the sedative effects of the medication, which may increase the possibility of a fall.

After using ZOLPIMIST

• Sleep medicines should in most cases, be used only for short periods of time. If your sleep problems continue, consult your doctor.
• Some medicines can cause dependence, especially when they are used regularly for longer than a few weeks. People who have been dependent on alcohol or other drugs in the past may have a higher chance of becoming addicted to sleep medicines. If you have been addicted to alcohol or drugs in the past, it is important to tell your doctor before starting ZOLPIMIST.
• Sometimes when medicines are stopped suddenly, after being used for a long time, withdrawal symptoms may occur. Symptoms of withdrawal may include abdominal and muscle cramps, vomiting and sweating. In some cases, your insomnia may appear worse for a short time; speak to your doctor if this occurs. Patients taking part in trials have not had any problems when they stopped taking ZOLPIMIST. However, let your doctor know if you have any problems when you stop taking ZOLPIMIST.

Driving or using machines

Because ZOLPIMIST will make you sleepy, you should not operate dangerous machinery or drive motor vehicles for 8 hours after you take it. You should also be careful the next morning when you wake up.

Make sure you know how you react to ZOLPIMIST before you drive a car or operate machinery. This is very important if you are taking other drugs that also make you drowsy.

Drinking alcohol

You should not drink alcohol while you are taking ZOLPIMIST.

Tell your doctor if you drink alcohol.

Alcohol may increase the risk of side effects or the effects of alcohol could be made worse while taking ZOLPIMIST.

Looking after your medicine

• Keep ZOLPIMIST in the child resistant packaging until it is time to use it.
• Keep the medicine in a cool, dry place where the temperature stays below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat, or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on windowsills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Head and neurology related: drowsiness dizziness headache fatigue anxiety nightmares Unexpected changes in behaviour. These have included rage reactions, worsened insomnia, confusion, agitation, depression, hallucinations, and other forms of unwanted behaviour. Gastrointestinal related: diarrhoea, nausea, and vomiting abdominal pain Musculoskeletal related: back pain muscle weakness Infection related: infections of the nose, throat, and chest Although these side effects can occur at the usual recommended doses, the risk of these behaviours occurring may also be increased if you take more than the recommended dose.

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Allergic reactions: swelling of the face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing hives fainting Sleepwalking and associated behaviours: Sleep walking, driving motor vehicles and other unusual, and on some occasions dangerous, behaviours whilst apparently asleep. These have also included preparing and eating food, making phone calls, or having sexual intercourse. People experiencing these effects have had no memory of the events.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Alcohol can increase the risk of sleep walking and other related behaviours. These side effects can also occur without the presence of alcohol. Although these side effects can occur at the usual recommended doses, the risk of these behaviours occurring may also be increased if you take more than the recommended dose.

Some sleep medicines may cause short-term memory loss. When this occurs, a person may not remember what has happened for several hours after taking the medicine. This is usually not a problem since most people fall asleep after taking the medicine.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What ZOLPIMIST contains

Active ingredient (main ingredient)	zolpidem tartrate (5 mg/actuation)
Other ingredients (inactive ingredients)	benzoic acid Cherry flavor Art 825.382 (ARTG PI No: 111494) citric acid monohydrate dilute hydrochloric acid neotame propylene glycol purified water

Do not take this medicine if you are allergic to any of these ingredients.

What ZOLPIMIST looks like

ZOLPIMIST (AUST R 315000) is presented in a two-part child-resistant polypropylene (PP) packaging system. An outer child-resistant PP base houses a type 1 amber glass bottle filled with Zolpimist spray solution fitted with a snap-on metered-dose pump assembly and clear over cap. The base and fitted components are then sealed using an outer child-resistant PP cap. ZOLPIMIST is supplied in Australia in one volume.

The 4.5 mL oromucosal spray contains 4.8 g of product formulation. There are 28 metered actuations per container after 7 initial priming actuations.

Who distributes ZOLPIMIST

Sponsor:

Arovella Therapeutics Ltd Unit 12, 55 Howe Street,
Osborne Park, WA 6017
Email: drugsafety@arovella.com
Tel: 1800 207 455
Website: www.arovella.com

Distributed by:

STADA Pharmaceuticals Australia Pty Ltd

This leaflet was updated in July 2022.