Melatonin prolongedrelease tablets (Circadin) for insomnia This Medicine Update is for people who are taking, or thinking about taking, prolongedrelease melatonin. Summary Melatonin prolonged-release tablets (Circadin) can be used by people over 55 years of age to treat sleeping problems (insomnia) not caused by other physical or psychological conditions. Medicines should only be used short term for sleep problems. Learning good sleep habits can be just as effective and lasts longer. If you and your doctor think that a medicine is necessary, prolongedrelease melatonin is an alternative to other sleep medicines that can have unpleasant side effects. Between 30% and 50% of people will probably get some benefit from prolonged-release melatonin either in the quality of sleep, or the time it takes to fall asleep. It does not seem to affect the overall length of time spent sleeping. Prolonged-release melatonin tablets do not seem to affect daytime alertness or cause addiction or withdrawal symptoms. Prolonged-release melatonin is approved for use for up to 3 months. www.nps.org.au/medicineupdate Independent, not-for-profit and evidence based, NPS enables better decisions about medicines and medical tests. We are funded by the Australian Government Department of Health and Ageing.
Contents section What prolonged-release melatonin is...1 What prolonged-release melatonin is for... 2 Who can take prolonged-release melatonin... 3 How to take prolonged-release melatonin... 4 What does prolonged-release melatonin do?... 5 Important side effects to consider... 6 What else you should know about prolonged-release melatonin... 7 Other medicines available for insomnia... 8 How to decide between melatonin and other medicines... 9 What does prolonged-release melatonin cost?...10 Other ways to relieve insomnia...11 Where to find more information...back page Asking the right questions about new medicines What is Medicine Update? Medicine Update provides independent information about new medicines and new listings on the PBS. It tells you about the possible benefits and harms of new medicines, who can and can't use them, and some of the other treatment options available. How to use Medicine Update Medicine Update is a tool to help you understand your treatment choices and to discuss them with your doctor. Medicine Update doesn t describe all possible side effects, precautions, or interactions with other medicines so you should always read the consumer medicine information (CMI) leaflet (see back page). Who is it for? Medicine Update is for anyone who is starting this medicine, or thinking of starting it, and their carers. Where does Medicine Update come from? Medicine Update is written by NPS: Better choices, Better health in consultation with consumers and health professionals. NPS is an independent, not-for-profit, governmentfunded organisation. This information is not intended to take the place of medical advice and you should seek advice from a qualified health professional. Reasonable care is taken to ensure that this information is accurate at the date of creation. Where permitted by law, NPS disclaims all liability (including for negligence) for any loss, damage or injury resulting from reliance on or use of this information. 2
1. What prolonged-release melatonin is The active ingredient of this medicine is melatonin (pronounced mel-ah-toe-nin). Melatonin is a chemical produced naturally by the body. Circadin is the brand name for a synthetic melatonin in the form of prolonged-release melatonin tablets. This Medicine Update is not about other forms of melatonin. The active ingredient is the chemical in the medicine that makes the medicine work. Many medicines are known by their brand names as well as by the name of the active ingredient. Some medicines are available under several different brand names. 2. What prolonged-release melatonin is for Prolonged-release melatonin is used to treat primary insomnia. Insomnia is a persistent sleep problem where people find it difficult to get to sleep or stay asleep, or they have poor quality sleep. This affects their ability to function properly the next day. Primary insomnia is when this sleep problem is not caused by a medical condition, another medicine, use of illicit drugs, or external reasons such as a poor sleeping environment. Sleep problems can be caused by: a medical condition (for example, pain or depression) another medicine use of illicit drugs a poor sleeping environment. In which case, the sleep problem is known as secondary insomnia. 3. Who can take prolonged-release melatonin Prolonged-release melatonin is approved for treating primary insomnia in people who are over 55 years of age. You will need a prescription from your doctor for prolonged-release melatonin. (See section 10 for information on the cost.) Speak to your doctor before taking prolonged-release melatonin if you: are pregnant or are breast-feeding are under 18 have liver or kidney problems have an autoimmune disease. Prolonged-release melatonin is not approved for treating jet lag. Prolonged-release melatonin is not suitable if you have secondary insomnia (see section 2 above). Studies into the effectiveness of prolonged-release melatonin demonstrated the best results in people 55 years of age or older. It was not found to be particularly effective for people younger than this. An autoimmune disease is where the body is attacked by the immune system. Some examples include rheumatoid arthritis, multiple sclerosis, lupus and inflammatory bowel disease. 3
3. Who can take prolonged-release melatonin... continued No matter which type of insomnia you have, ask your health professional for advice about improving your sleep habits. This can be an effective way to solve sleep problems without taking medicines. Talk with your health professional about all the treatment options for your insomnia. Resources with advice on how to get a good night s sleep are available from www.nps.org.au/ sleep 4. How to take prolonged-release melatonin Take one prolonged-release melatonin tablet at around the same time each night 1 to 2 hours before going to bed. Don't take it much earlier as this may cause problems with waking early. Swallow the tablet whole with water. Don t crush, chew or break the tablet. It s best to take the tablet soon after eating, as this will help with the prolonged-release effect for this form of melatonin. You should avoid drinking alcohol before or after taking a tablet. Alcohol interferes with the absorption of melatonin so that it may be less effective. Ask your doctor how long to take prolonged-release melatonin for. It is approved for up to a maximum of 3 months (13 weeks). There is no evidence that the benefits are maintained when you stop taking it. 5. What does prolonged-release melatonin do? The melatonin your body produces naturally usually increases as it is getting dark and continues to rise during the night. This helps to regulate the body s sleep wake cycle. It is thought that as we age, natural melatonin levels reduce and this may contribute to sleep problems. Prolonged-release melatonin tablets provide your body with additional melatonin. This may improve your quality of sleep and morning alertness. In clinical trials, prolonged-release melatonin helped improve some aspect of sleep (e.g. sleep quality, morning alertness) for between 30% and 50% of people. However, the same improvements were found in 20% to 30% of people taking a dummy pill (placebo). The time it took to fall asleep was reduced by an average of 9 minutes. But there was no significant change in the length of time spent sleeping. A clinical trial is a research study conducted with patients, which compares one treatment with one or more other treatments, or with no other treatment, to assess its effectiveness and safety. A dummy pill, or placebo, has no active ingredient. Participants in clinical trials do not know whether they are taking the active or dummy medicine. To find out more about clinical trials, see What are clinical trials and why are they important? at www.nps.org.au/medicinewise_ choices 4
6. Important side effects to consider All medicines can have side effects. Sometimes the side effects are serious, but most of the time they are not. People reported several different side effects in clinical trials. The most frequently reported common side effects were: headache respiratory infections back pain joint pain feeling weak or tired. Information on the side effects from taking melatonin for longer than 6 months is still limited. Melatonin doesn t seem to be addictive or cause withdrawal effects occur after stopping. For a list of possible side effects, see the consumer medicine information (CMI) leaflet for Circadin (prolonged-release melatonin). Common is one of the terms used to describe the chance of getting a side effect. It means that up to 1 in 10 people (10%) might get that side effect. Always tell your doctor about any changes to your condition if you are taking a new medicine. You can also discuss side effects with a pharmacist by calling the Adverse Medicines Event (AME) Line on 1300 134 237 (Mon Fri, 9am 5pm). 7. What else you should know about prolonged-release melatonin Do not take melatonin with other medicines for sleep problems, including non-prescription or herbal remedies, as it may interact with them. In particular, you should not take melatonin if you are taking the following medicines: prescription sleep medicines such as hypnotics and tranquilisers (e.g. benzodiazepines, zolpidem see list in section 8) fluvoxamine, imipramine and thioridazine (used to treat depression or psychiatric problems). It may also interact with: carbamazepine (used to prevent seizures and convulsions) cimetidine (used to treat stomach ulcers and heartburn) oestrogen (contraceptives or hormone replacement therapy). Check with your doctor or pharmacist before using these medicines together. Prolonged-release melatonin rarely causes daytime drowsiness, but it is not recommended that you drive or operate machinery for 8 hours after you take it. If you do feel drowsy during the day, you should consult your doctor. An interaction is when another medicine, food or drink (including alcohol) changes how strongly a medicine works, or changes its side effects in some way. The interaction may be with a food or food supplement, another prescription or over-thecounter medicine, or a natural or herbal remedy. The NPS Medicines Name Finder (www.nps.org.au/ medicinenamefinder) can help you identify your prescription medicines by the active ingredient name and brand name. Use a medicine list to help keep track of the medicines you are taking. Take it with you each time you visit your health professional, or if you go into hospital. Get an NPS Medicines List as a printed card or app for your iphone at www.nps.org.au/ medicineslist 5
8. Other medicines available for insomnia There are ways to improve your sleep without using medicines see section 11 for more information. Your doctor can also help you find out about cognitive and behavioural therapies for insomnia. These have been found to be just as effective as medicines and have a longer-lasting effect on sleep. Most prescription sleep medicines are only suitable for short-term use because of the risk of side effects and addiction. Several complementary medicines including chamomile, hops, lavender, passiflora and valerian are used to treat insomnia. There is some evidence to suggest that valerian may be helpful (see section 9), but less for the others. Avoid sedating antihistamines People sometimes use medicines called sedating antihistamines to help them sleep. These are available over the counter at pharmacies. But they are not suitable for treating insomnia, particularly in older people, because they quickly stop being effective. They can also cause unpleasant side effects such as dry mouth, constipation and blurred vision. Examples of prescription sleep medicines Active ingredient Brand names Flunitrazepam Nitrazepam Temazepam Zolpidem Zopiclone Hypnodorm Alodorm Mogadon Normisom Temtabs Temaze Dormizol Somidem Stildem Stilnox Zolpibell Imovane Imrest Examples of sedating antihistamines Active ingredient Brand names Diphenhydramine Snuzaid, Unisom Sleepgels Doxylamine Promethazine Dozile, Restavit Phenergan 9. How to decide between melatonin and other medicines Talk to your doctor or pharmacist about your insomnia. Remember, effective non-drug options are available and are probably more helpful than medicines in the long term. You need to consider the side effects as well as the potential benefits when deciding to take a medicine for insomnia. No medicine should be taken for longer than the recommended period. Remember that benefits and side effects differ between medicines and from person to person. Melatonin only helps some people In clinical trials, between 30% and 50% of people who took prolonged-release melatonin felt their sleep had improved. But so did 20% to 30% of people who took a dummy pill (placebo). The time taken to fall asleep, quality of sleep and morning alertness may improve, but not the total length of time spent sleeping. Many prescription sleep medicines are addictive The prescription sleep medicines listed in section 8 like nitrazepam and zolpidem are generally effective. But they can disturb the normal rhythm of sleep so it may not be as deep or restful. They should only be used for a short time. If you take them for longer than 4 weeks, it can be difficult to stop. And when you do stop, you may get withdrawal symptoms including muscle pain, tremors, anxiety and depression or your insomnia might be worse than it was before (rebound insomnia). For more information about zolpidem, see the NPS fact sheet at www.nps.org.au/ consumers/publications/ factsheets/factsheets/ medicine-specific/ zolpidem_including_ stilnox_brand There is currently no evidence to suggest that prolonged-release melatonin causes dependence or withdrawal effects. 6
9. How to decide between melatonin and other medicines... continued Some medicines may affect you during the day Prolonged-release melatonin doesn t seem to cause problems with drowsiness or concentration during the day for most people. But other sleep medicines can. Problems include drowsiness, poor concentration, memory loss and dizziness. These can increase the risk of a fall or a car accident. Possible side effects when you re asleep Zolpidem and zopiclone (see section 8) have been linked to uncommon but potentially dangerous side effects like sleepwalking, sleep-eating and sleep-driving. There is currently no evidence to suggest that other prescription sleep medicines or prolonged-release melatonin cause similar effects. What about complementary medicines? Some studies suggest that valerian can reduce the time it takes to fall asleep and improve the quality of sleep. But the studies only lasted for about 6 weeks, so they did not provide information about longer term use. 10. What does prolonged-release melatonin cost? Prolonged-release melatonin is not covered by the Pharmaceutical Benefits Scheme (PBS). It is only available by private prescription. The price may vary between different pharmacies, but as an indication you should expect to pay around $30.00 for 3 weeks supply of prolonged-release melatonin tablets. When a medicine prescribed by your doctor is not covered by the Pharmaceutical Benefits Scheme (PBS), you will need to pay the full price. For more information, see www.pbs.gov.au You can find out more about private prescriptions at www.nps.org.au/ consumers/publications/ medicines_talk/mt15/ private_prescriptions2 7
11. Other ways to relieve insomnia Developing good sleep habits is more effective than using medicines. In the long term, most sleep medicines usually make sleep problems worse, not better. If you re having problems sleeping, these tips will get you on the right track: Try to go to sleep and wake up at the same time each day. Be as active as possible during the day and spend some time outdoors. Reduce the amount of caffeine you have each day and avoid caffeinated drinks after lunchtime. Avoid naps during the day. If you do nap, keep it to 20 minutes and before 3pm. Avoid heavy meals, exercise or working on the computer late in the evening. Avoid smoking and drinking alcohol in the evening. Relax for 30 minutes before going to bed (e.g. take a warm bath or listen to music). Don t eat, work, watch television, read or discuss problems in bed. Make sure your bedroom is not too hot or cold. Ensure you are comfortable and your bedroom is quiet and dark. Don t stay in bed if you are awake for more than 20 minutes go to another room and do something relaxing. The following resources with advice on how to get a good night s sleep are available from the NPS website at www.nps.org.au/sleep: Sleep right, sleep tight fact sheet Sleep right, sleep tight sleep diary to record your sleep habits complete and take to your doctor to use as the basis for discussing your sleep problems Sleep right, sleep tight quiz to help you assess your quality of sleep. 8
Where to find more information Read the consumer medicine information (CMI) leaflet The CMI for Circadin (prolonged-release melatonin) will tell you: who should not use the medicine how to take the medicine most of the possible side effects the ingredients. You can get the CMI leaflet for Circadin from: your doctor of pharmacist the CMI search on the Therapeutic Goods Administration (TGA) website at www.tga.gov.au/consumers/ information-medicines-cmi.htm Call Medicines Line for information over the phone NPS works with healthdirect Australia to provide consumers with information on medicines. To get information about prolonged-release melatonin, call 1300 MEDICINE (1300 633 424) from anywhere in Australia for the cost of a local call (excluding mobiles). This service is available Monday to Friday, 9am 5pm EST, with the exception of NSW public holidays. To report a side effect with prolonged-release melatonin Call the Adverse Medicines Event (AME) Line on 1300 134 237 (Monday to Friday, 9am 5pm EST). The AME Line lets you report and discuss side effects that might be related to your medicine. The side effects of your medicine but not your personal details are reported to the Australian medicines regulatory agency, the Therapeutic Goods Administration (TGA). The information helps to improve the safe use of medicines. For more information about the AME Line, visit www.nps.org.au/ame_line More about using medicines wisely For more information on how to make wise choices about taking medicines, see Medicinewise choices at www.nps.org.au/medicinewise_choices More information on understanding side effects is available from www.asmi.com.au Date published: August 2011 Visit the NPS website to find out about our free activities and resources for consumers www.nps.org.au/consumers Independent, not-for-profit and evidence based, NPS enables better decisions about medicines and medical tests. We are funded by the Australian Government Department of Health and Ageing. 2011 National Prescribing Service Limited. This work is copyright. You may download, display print and reproduce this work in unaltered form only (retaining this notice) for non-commercial use either personally or within your organisation. Apart from any such use or otherwise as permitted under the Copyright Act 1968, all rights are reserved. Queries concerning reproduction and rights should be sent to info@nps.org.au. ABN 61 082 034 393 l Level 7/418A Elizabeth Street Surry Hills NSW 2010 l PO Box 1147 Strawberry Hills NSW 2012 Phone: 02 8217 8700 l Fax: 02 9211 7578 l email: info@nps.org.au l web: www.nps.org.au