SOMIDEM®
| Consumer Medicine Information (CMI) summary |
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.
| 1. Why am I using SOMIDEM? |
SOMIDEM contains the active ingredient zolpidem tartrate. SOMIDEM is used to initiate and maintain sleep in those with sleeping difficulties, also called insomnia, in patients over 18 years of age. For more information, see Section 1. Why am I using SOMIDEM? in the full CMI.
| 2. What should I know before I use SOMIDEM? |
Do not use if you have ever had an allergic reaction to SOMIDEM or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, have been drinking alcohol, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use SOMIDEM? in the full CMI.
| 3. What if I am taking other medicines? |
Some medicines may interfere with SOMIDEM and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
| 4. How do I use SOMIDEM? |
- In adults: usual dose is one 10 mg tablet taken just before bedtime.
- In people over 65 years of age: the dose is one 5 mg tablet taken just before bedtime.
More instructions can be found in Section 4. How do I use SOMIDEM? in the full CMI.
| 5. What should I know while using SOMIDEM? |
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Drinking alcohol |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using SOMIDEM? in the full CMI.
| 6. Are there any side effects? |
Common side effects are: drowsiness, dizziness, headache, fatigue, worsened insomnia, hallucinations, delirium, nightmares, agitation, depression, abdominal pain, diarrhoea, nausea and vomiting, back pain, infections of the nose, throat and chest and loss of memory.
If any of the following happen, stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital: swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, hives, fainting. Sleep walking, driving motor vehicles and other unusual, and on some occasions dangerous, behaviours whilst apparently asleep may also occur. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
| WARNING: SOMIDEM 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 SOMIDEM AND PARTICULAR CAUTION IS NEEDED WITH OTHER DRUGS THAT MAY ALSO ACT ON THE BRAIN; BEFORE YOU TAKE SOMIDEM REFER TO THE "TAKING OTHER MEDICINES" SECTION BELOW OR ASK YOUR DOCTOR OR PHARMACIST. YOU MUST NOT DRINK ALCOHOL WHEN YOU TAKE SOMIDEM. DO NOT TAKE SOMIDEM FOR MORE THAN 4 WEEKS. IF YOUR SLEEP PROBLEMS CONTINUE, CONSULT YOUR DOCTOR. |
SOMIDEM®
Active ingredient(s): Zolpidem tartrate
| Consumer Medicine Information (CMI) |
This leaflet provides important information about using SOMIDEM. 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 SOMIDEM.
Where to find information in this leaflet:
1. Why am I using SOMIDEM?
2. What should I know before I use SOMIDEM?
3. What if I am taking other medicines?
4. How do I use SOMIDEM?
5. What should I know while using SOMIDEM?
6. Are there any side effects?
7. Product details
| 1. Why am I using SOMIDEM? |
SOMIDEM contains the active ingredient zolpidem tartrate. SOMIDEM 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.
SOMIDEM has a different chemical structure to other sleeping tablets. It works by binding to special sites in the brain which produce sleep.
Your doctor may have prescribed it for another reason.
| 2. What should I know before I use SOMIDEM? |
Warnings
Do not use SOMIDEM 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.
Do not give SOMIDEM to a child or adolescent. There is no experience with its use in children or adolescents under 18 years of age.
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 SOMIDEM.
- have, or have 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, SOMIDEM is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of taking it if you are pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
SOMIDEM can pass into breast milk. Your doctor will discuss the risks and benefits of using it if you are breast-feeding 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.
| 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 SOMIDEM and affect how it works.
Medicines that may increase the effect of SOMIDEM 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 used 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 SOMIDEM include:
- St John's Wort (also known as Hypericum), a herbal remedy used to treat depression
- Rifampicin, a medicine used to treat infection
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SOMIDEM.
| 4. How do I use SOMIDEM? |
How much to take
- The usual adult dose of SOMIDEM is one tablet (10 mg).
- If you are over 65 years of age the dose is half a SOMIDEM tablet (5 mg).
- If you have any liver problems, the usual recommended dose is half a STILNOX tablet (5 mg). Do not take STILNOX if you have severe liver problems.
- Your doctor may have prescribed a different dose. The lowest effective daily dose should be used and must not exceed 10 mg. Follow the instructions they give you.
- If you take the wrong dose, SOMIDEM may not work as well.
- If you take too much your consciousness may be impaired (see 'If you take too much SOMIDEM' below).
- Ask your doctor if you are unsure of the correct dose for you. They will tell you exactly how much to take.
When to take SOMIDEM
- Take SOMIDEM immediately before you go to bed or while you are in bed.
- SOMIDEM 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.
How long to take it
- Usually, SOMIDEM 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.
How to take SOMIDEM
- Swallow the tablet whole with a full glass of water, unless your doctor has told you to take half a tablet.
- It helps put you to sleep quite quickly. If you take SOMIDEM on an empty stomach it may work faster.
If you forget to use SOMIDEM
If you forget to take SOMIDEM 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 SOMIDEM
If you think that you have used too much SOMIDEM, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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.
You may need urgent medical attention.
If you take too much SOMIDEM, your consciousness may be impaired, ranging from drowsiness to light coma.
| 5. What should I know while using SOMIDEM? |
Things you should do
Tell all the doctors, dentists and pharmacists who are treating you that you are taking SOMIDEM.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking SOMIDEM.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.
If you become pregnant or suspect that you are pregnant while you are taking SOMIDEM, stop taking it and tell your doctor or pharmacist immediately.
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 SOMIDEM.
Things you must 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 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.
Things to be careful of
- Be careful if you are over 65 and unwell or taking other medicines. You may be more sensitive to some of the side effects of SOMIDEM. Some patients may be particularly susceptible to the sedative effects of this medication, which may increase the possibility of a fall.
After taking SOMIDEM
- 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 SOMIDEM.
- 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 which may be accompanied with other reactions including mood changes, anxiety and restlessness; speak to your doctor if this occurs. Patients taking part in trials have not had any problems when they stopped taking SOMIDEM. However, let your doctor know if you have any problems when you stop taking SOMIDEM.
Driving or using machines
Because SOMIDEM 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 SOMIDEM 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 SOMIDEM.
Tell your doctor if you drink alcohol.
The effects of alcohol could be made worse while taking SOMIDEM.
Looking after your medicine
- Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
- Keep your tablets in a cool dry place where the temperature stays below 25°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 window sills.
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.
Tell your doctor as soon as possible if you do not feel well while you are taking SOMIDEM.
Less serious side effects
| Less serious side effects | What to do |
Head and neurology related:
| 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:
| 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 SOMIDEM contains
| Active ingredient (main ingredient) | zolpidem tartrate 10 mg |
| Other ingredients (inactive ingredients) | lactose monohydrate microcrystalline cellulose pregelatinised maize starch magnesium stearate Instacoat Universal White A05G13783 |
| Potential allergens | lactose |
Do not take this medicine if you are allergic to any of these ingredients.
What SOMIDEM looks like
SOMIDEM is a white to off-white, capsule-shaped breakable tablet, marked "ZM break line 10" on one side and "G" on the other side (AUST R 119196).
Who distributes SOMIDEM
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in July 2023.
SOMIDEM® is a Viatris company trade mark
SOMIDEM_cmi\Jul23/00
Published by MIMS September 2023