Medication: Zaleplon
expandZaleplon was often known by the brand name Sonata®. It is one of a group of medicines called the "Z" hypnotics . Hypnotics make you sleepy and are used as a short term treatment of insomnia (or difficulty in getting to sleep or staying asleep).
Zaleplon was first made available in the UK in 2000. It is used across the UK and the rest of the world for sleep problems but is not used much these days.
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9.10
- What is zaleplon used for?
Zaleplon is called a "hypnotic" and makes you sleepy. It can be used as a short term treatment of insomnia (or difficulty in getting to sleep or staying asleep). Insomnia i.e. difficulty in going to sleep or staying asleep, is not an illness itself but can cause distress and make some conditions worse e.g. bipolar mania. Any causes of insomnia should, where possible, be identified and treated. The principles of 'sleep hygiene' should also be taken seriously. These principles of sleep hygiene are:
1. Avoid excessive use of caffeine, alcohol or nicotine. A hot milky (decaffeinated) drink at bedtime may help
2. Do not stay in bed for a long time if you are not asleep
3. Avoid daytime naps or long periods of inactivity
4. A warm bath or exercise a few hours before bedtime may help sleep
5. Avoid strenuous exercise or mental activity near bedtime
6. Make sure that the bed and bedroom are comfortable and avoid excess noise and temperature (ear-plugs may help if there is much noise)
7. Get up at the same time every morning, regardless of how long you slept (this makes sure that you are ready for sleep the next night).8.10
- How does zaleplon work?
Sometimes if your brain is too active, you cannot get off to sleep. Your brain usually produces a chemical messenger (or "neurotransmitter") called GABA (gamma-aminobutyric acid). This is the brain's naturally occurring "calmer". Zaleplon boosts the effect of GABA, which helps calm the brain down and helps you go to sleep.
8.10
- How should I take zaleplon?
The tablets or capsules should be swallowed with at least half a glass of water whilst sitting or standing. This is to make sure that they reach the stomach and do not stick in your throat.
8.10
- When should I take zaleplon?
Take your zaleplon when you go to bed as it has a quick action (possibly in about 15 minutes). It is also short-acting and has little or no hangover effect. It is thus possible to have a dose up to about 2am if you have not yet gone to sleep. The hypnotic effect should have gone within about two hours.
8.10
- How long will zaleplon take to work?
Zaleplon will start to work about 15 minutes to half an hour after you take it. Your doctor may need to adjust the dose to suit you, if they do not work or make you too sleepy the next morning.
8.10
- How long will I need to keep taking zaleplon?
This should be discussed with your doctor as people respond differently. Zaleplon is a safe drug if used sensibly. You should take as low a dose as possible for the shortest time possible. This would best be for no longer than about one month, to help you get over your sleep problems. If you need to take it for longer you should talk about this with your doctor. Taking it only when you need it, or every few days (e.g. alternate nights), can be a useful way to use zaleplon safely.
8.10
- Is zaleplon addictive?
If you take zaleplon regularly every night for more than about four to six weeks you might have problems sleeping if you stop. This is called "rebound insomnia". This is not likely if you do not have a dose every night. This problem can happen when you stop zaleplon, or a few days later. It may last for a few weeks but could go on for longer. If you have taken zaleplon for a long time you may need to stop it gradually by reducing your dose every few days or weeks, just to let your brain get used to the change. It is also true to say that many people get no problems at all when they stop, even if they have been taking zaleplon for a while.
8.10
- Can I stop taking zaleplon suddenly?
Zaleplon is probably best not stopped suddenly if you have been taking 20mg a day (or more) every night for more than about a month or so. If you do, you may get some rebound insomnia (see above). It is best to reduce the dose to 10mg at night and then stop. If you only take zaleplon when you really need it this is better than taking it continuously and can help stop you becoming dependent on it. You should discuss this with your doctor.
8.10
- What should I do if I forget to take a dose of zaleplon?
Take the dose as soon as you remember. If you went to sleep without it, that is absolutely fine. If you take a dose too late at night you may feel more drowsy the next morning.
8.10
- What sort of side effects might occur if I am taking zaleplon?
The table below will show you some of the side effects you might get from zaleplon.
The side effects listed here are grouped as follows:
- Very common = more than 1 in 10 people get this side effect
- Common 1 in 10 to 1 in 100 (1-10%) get this side effect
- Uncommon or less common = 1 in 100 to 1 in 1,000 (0.1-1%) get this side effect
- Rare = 1 in 1,000 to 1 in 10,000 (0.01-0.1%) get this side effect
- Very rare = less than 1 in 10,000 (0.01%) people get this side effect
But remember for each side effect:
- It is often dose related i.e. the higher the dose the more likely you are to get it, especially if you have a higher starting dose
- We have not included all side effects (see the information leaflet that came with the medicine for the rest)
- Many side effects may wear off with time (or, rarely, get worse)
- Everyone is unique so it is impossible to say who will get what side effect and who won't
Side effect What happens What to do about it ZALEPLON
Drowsiness or dizziness
You feel sleepy or sluggish the next morning.
Don't drive or use machinery.
Discuss with your doctor – it may be better to adjust the dose or try a different drug.
Headache
Your head is pounding and painful.
Try paracetamol. Your pharmacist will be able to advise if this is safe to take with any other medicines you may be taking.
Changes in behaviour
Feeling excitable. You may be talkative, unfriendly or disinhibited.
This is very rare, but discuss this with your doctor if it happens. He or she may want to adjust your drug or dose.
Table adapted from UK Psychiatric Pharmacy Group leaflets, with kind permission www.ukppg.org.ukDo not be worried by this list of side effects. You may get none at all. There are other rare side-effects. If you develop any unusual symptoms ask your doctor about them next time you meet.
- Will zaleplon make me feel drowsy?
Zaleplon is used to help you sleep and so should make you feel drowsy. You may, however, feel drowsy or sleepy the next morning. Because zaleplon has a very short action, this is unlikely unless you take a dose during the night. If so, you should take extra care is you have to drive or operate machinery. Zaleplon could also affect your reaction times, even if you feel OK.
8.10
- Will zaleplon make me put on weight?
It is not thought that zaleplon causes any changes in weight. If you do start to have problems with your weight, however, tell your doctor next time you meet as he or she can arrange for you to see a dietician for advice.
8.10
- Will zaleplon affect my sex life?
Zaleplon is not thought to have any effects on your sex life. Unless of course you have already gone to sleep.
8.10
- Are there any foods of drinks I need to avoid if I am taking zaleplon?
You should have no problem with any foods or drinks, other than alcohol (see separate question).
8.10
- Can I drink alcohol while I am taking zaleplon?
You should avoid alcohol while taking zaleplon as it may make you feel more sleepy. This is particularly important if you need to drive or operate machinery and you must seek advice on this. Zaleplon can also increase the effects of alcohol.
8.10
- Will zaleplon affect any of my other medicines?
Zaleplon has a few interactions with other medicines:
- Zaleplon can cause drowsiness (a bit obvious, as that's the reason people take it!) and so you should be careful if taking it with another medicine or drug that causes drowsiness e.g. alcohol or benzodiazepines (e.g. diazepam, lorazepam, temazepam)
- The effects of zaleplon can be increased by ketoconazole, erythromycin or cimetidine and decreased by carbamazepine or phenobarbital
This does not necessarily mean that this will happen in everyone or that some of these medicines can not be used together. It just that you may need to follow your doctor's instructions very carefully. There are many other possible drug interactions.
8.10
- If I am taking a contraceptive pill, will this be affected by taking zaleplon?
- What if I want to start a family or find I'm pregnant while taking zaleplon?
It is important to consider that there will be a risk to you and your child from taking a medicine during pregnancy but also a possible risk from stopping the medicine e.g. getting ill again. Unfortunately, no decision is risk-free. It will be for you to decide which is the least risk. All we can do here is to help you understand some of the issues, so you can make an informed decision. For your information, major malformations occur "spontaneously" in about 2-4% of all pregnancies, even if no drugs are taken. The main problem with medicines is termed "teratogenicity" i.e. a medicine causing a malformation in the unborn child. A medicine causing teratogenicity is called a "teratogen". Since a baby has completed it's main development between days 17 and 60 of the pregnancy (the so-called "first trimester") these first 2-16 weeks are the main concern. After that, there may be other problems e.g. some medicines may cause slower growth. The infant may also be affected after birth e.g. withdrawal effects are possible with some drugs.
If possible, the best option is to plan in advance. If you think you could become pregnant, discuss this with your doctor and it may be possible to switch to medicines thought to carry least risk, and take other risk-reducing steps e.g. adjusting doses, taking vitamin supplements etc. If you have just discovered you are pregnant, don't panic, but seek advice from your GP within the next few days if possible. He or she may also want to refer you on to someone with more specialist knowledge of your medicine.
Very few medicines have been shown to be completely safe in pregnancy and so no manufacturer or advisor can ever say any medicine is safe. They will usually advise not to take a medicine during pregnancy, unless the benefit is much greater than the risk. In the UK, there is the NTIS (National Teratology Information Service) who offer individual risk assessments. However, their advice should always be used to help you and your doctor decide what is the risk to you and your baby. There is a risk from taking the medicine and a risk should you stop a medicine e.g. you might become ill again and need to go back on the medication again. The advice offered here is just that i.e. advice, but may give you some idea about the possible risks and what (at the time of writing) is known through the medical press.
It may be helpful to know that in the USA, the FDA (Food and Drug Administration) classifies medicines in pregnancy in five groups:- A = Studies show no risk, so harm to the unborn child appears only a remote possibility
- B = Animal and human studies indicate a lack of risk but are not fully conclusive
- C = Animal studies indicate a risk but there is no safety data in humans
- D = a definite risk exists but the benefit may outweigh the risk in some people
- X = the risk outweighs any possible benefit
Zaleplon is classified as "C". Although there is no evidence of a teratogenic effect, and animal tests show a low risk of danger there are safer hypnotics so you should still seek personal advice from your GP. He or she may then if necessary seek further specialist advice. Occasional use of a low dose would probably be of a low risk.
8.10
- Will I need any blood tests if I am taking zaleplon?
- Can I drive if I am taking zaleplon?
All hypnotics can reduce your ability to carry out skilled tasks such as driving or operating machinery. You may also feel drowsy the day after you take them, especially if you then drink alcohol. Until these effects wear off or you know how zaleplon affects you do not drive or operate machinery. You should be careful as it may affect your reaction times, even though you may feel OK.
Under Section 4 of the Road Traffic Act 1988 anyone driving while unfit to drive, due to illness or any drug, can be prosecuted. Under UK law it does not matter if the drug is a prescribed medicine or an illegal drug. It’s the effect on your driving that is the main thing. If your ability to drive might be reduced due to illness or medicines, under UK law you must let your insurance company know. If you don’t, the insurance might say this is as 'withholding a material fact' (ie not telling them something they ought to know) and might mean that if you have an accident they might not pay up. Your doctor will be able to advise you.
Medical rules for all drivers:
For the full story click here (opens in new window) and go to "Medical standards". Here there is a pdf document (regularly updated) called "At a glance guide to the current medical standards of fitness to drive" that can be downloaded. It is aimed at medical practitioners (GPs).
For the "Customers guide" (ie a guide for the general public) click here (opens in new window) and download the 'Customer service guide for drivers with medical conditions'.
How to tell the UK DVLA:
If you need to tell the DVLA and you already have a license, you need to download the medical questionnaire from the DVLA website. Or you can call the DVLA to ask them to send it to you. You also need to fill out a form to give your consent for doctors from the DVLA doctors to contact your doctor or a specialist. You can either post, fax or email these forms back to:
Drivers Medical Group, DVLA, Swansea, SA99 1TU
Tel: 0870 600 0301
Fax: 0845 850 0095
Email: eftd@dvla.gsi.gov.uk
Web www.direct.gov.uk/motoring (opens in new window)
You should always allow DVLA to contact your doctor, as what your doctor says will help the DVLA decide if you can keep your license. Rarely, the DVLA may ask you to have a (free) medical examination, which will be free. This is called a medical enquiry.
What happens next
If you give the DVLA all the information they need, they can usually sort things out within 15 days. If they need more information from you, your doctor or other sources, they will try to sort it out within 90 days. What they decide will also depend on what you’re doing e.g. driving a bus is different to driving down to the shops. What can happen includes:- You may be able to keep your license or be issued with a new one.
- If the DVLA’s doctor thinks your fitness to drive needs to be reviewed again, you may be given a license valid for 1, 2 or 3 years.
- Your license may be taken from you (revoked) or your application refused. This will only happen if you do not meet the standards of fitness to drive at the moment. If this happens, you would be told the reasons for the decision. You would also be told when you can apply again.
Driving safely
If you want to carry on driving, you must take sensible steps to reduce any risk:- Avoid driving when you are tired or ill
- Do not drive after having any alcohol as this can make an drowsiness worse (a third of all fatal road traffic incidents involve alcohol-dependent drivers)
- Avoid driving at night, dusk or in bad weather
- Avoid motorways, dual carriageways and the rush hour
- Give yourself plenty of time. Don’t rush
- Be extra careful if you have not slept well the previous night
As some medicines can affect your driving, be extra careful:
- If starting a new medicine
- After a change in dose (especially an increase)
- If you are on a high dose or seem very sensitive to side effects
- If you are taking any medicines for other symptoms e.g. antihistamines for hay fever or allergies
- If your medicine causes you blurred vision, drowsiness, poor co-ordination, poor attention
If you are driving less than 2000 miles a year, once you consider insurance, tax, MoT, repairs, maintenance and petrol, you may actually find it is cheaper to get taxis and busses, and walk the short journeys.
