There are a number of options to print:

• Click "Print this page" on the left to print the whole section
• Download a handy PILL (Patient Information Leaflet), a two-page summary of the main questions and answers from here for zaleplon. This can then be printed.
• Download a handy QuILL (Quick Information Leaflet), a shorter, pictorial version of the PILL, designed for younger people. This can then be printed.
• Download a BILL (Basic Information Leaflet), a one-page larger print basic summary of the really main questions and answers from here. This can then be printed.

There are many other Patient Information Leaflets (PILs) across the world for patients and carers. There are also official information leaflets (often called a Data Sheet, Package Insert, or Summary of Product Characteristics). They are not on our site, so we can't take any responsibility for them but you can click here for links to other sites and leaflets.

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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).

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The usual dose of zaleplon for adults is 10mg at bedtime. It can be taken after going to bed if you are finding it hard to get to sleep. In older people the dose should be 5mg, as it can cause more drowsiness.

It is not recommended in children but this is only because it has not been studied rather than because of any concerns about safety.

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To help you choose, click on the links for the main options (self-help and help from others), the main medicines, and a handy chart comparing the main medicines for:

• Insomnia - main options, main medicines and handy chart

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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.

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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.

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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.

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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. See also insomnia.

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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. See also insomnia.

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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. 

For a drug to be addictive or produce dependence, then it must have a number of characteristics:

• should produce craving for the drug when the last dose "wears off"

• there should be a "reward" (e.g. a good feeling) from taking the drug

• should produce tolerance ie you need more drug to get the same effect

• should produce withdrawal symptoms specific to that drug.

These characteristics come from the World Health Organisation. Zaleplon can cause some discontinuation effects and some tolerance and so has some addictive potential. However, these are not usually serious if just taking it just to help sleep.

Click here to read a bit more about this, where you can find our thoughts on this knotty problem.

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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.

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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.

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The table below will show you some of the main side effects you might get from zaleplon. These are a few side effects from taking higher doses of zaleplon, but if you just take it at night then you will probably get very few side effects.

Do not be worried by this list of side effects. Some people get no side effects at all and others may get some effects that are not listed in this table. Side effects tend to be worse with higher doses. Starting with a lower dose sometimes helps. If you think you might have a side effect to your medicine, you should discuss this with your doctor, nurse of pharmacist. You should also see the manufacturer's information leaflet.

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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.

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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.

Click here for a few tips on how to help you feel less hungry and lose weight.

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Drugs can affect desire (libido), arousal (erection) and orgasmic ability. Zaleplon is not thought to have any effects on any of these stages. Unless of course you have already gone to sleep.

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You should have no problem with any foods or drinks, other than alcohol (see separate question).

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Whether or not it is safe to drink alcohol with any medicine will depend on:

• How much you have to drink e.g. the amount and over how long
• What you then try to do (e.g. sleep or drive)
• If you have any other conditions e.g. epilepsy, asthma or a chest infection (as alcohol can make it harder to breathe)
• If you are taking any other medicines

Alcohol reaches all parts of the brain and can affect many things e.g. thinking, reactions and breathing. Alcohol can also boost the effect of GABA (the brain's main calming chemical messenger).

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. You might also increase your risk of sleep-walking.  

It is not safe to drive after drinking alcohol, with or without zaleplon. Some countries allow driving after a small amount of alcohol but others have a zero tolerance. The UK has the highest limit in Europe, France lower, Scandanavia even lower and zero in some Eastern European countries. It is not possible to say what blood level you might have from a drink so it is safest not to drink if you know you may have to drive. It is taken as a very serious offence in most countries. You should see National Guidelines, laws and regulations in the country in which you are driving.

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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 is just that you may need to follow your doctor's instructions very carefully. There are other possible drug interactions (e.g. you can try an external on-line drug interactions checker, although this is nothing to do with our site).

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Cigarette smoke contains over 3000 different chemicals. Some of these chemicals can make some of the enzymes in the liver work faster (called "enzyme induction" of e.g. CYP1A2 or P4501A2). This means that any medicine those enzymes break down will be broken down quicker. So, you'll end up with less of that medicine if you smoke. And also you will have more of it in the body if you stop smoking. However, it seems that there are no extra problems if smoking with zaleplon.

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By including this section, we're not saying it's right to take illicit or illegal drugs, because it isn't. We're just trying to answer the questions as best we can under the circumstances. With illicit drugs, the full answer is usually that we don't really know. So, we can only go on a few studies, a few reports and what we know about the drugs themselves.

Cannabis (illegal in most countries):

Smoking cannabis increases the amount of dopamine in the pleasure centres of the brain, which is where the reward or buzz comes from. However, psychosis also comes from having too much dopamine in another area of the brain. You have to remember that cannabis can increase dopamine in all areas of the brain and so can make psychosis worse. Please be careful, everything in moderation and if dope makes you worse, keep off the grass. It really won't help you in the long-term. Don't forget that if you're a toker, you're also a smoker, so see the question above. However, zaleplon does not seem to be affected so there seem to be no extra problems if smoking cannabis with zaleplon, although you might feel a little more drowsy.

Cocaine (illegal in most countries)

Cocaine is of course highly addictive and has many adverse or side effects on the body and brain. It can make most mental health symptoms worse in the long-term. However, there are no reports of extra problems with zaleplon and cocaine, although this doesn't mean it's safe.

Ecstasy (illegal in most countries)

Ecstasy has many effects on the brain, the main ones producing the high seem to be by boosting serotonin, noradrenaline and dopamine in the brain. While it can cause a high, the effect wears off fairly quickly. It seems that the toxic effects on the brain are cumulative i.e. the more tablets you have over your lifetime, the more chance you have of having damage to the brain e.g. long-term depression and poor memory. However, there are no reports of extra problems with zaleplon and ecstasy, but again this doesn't mean it's safe.

Opiates

The opiates include many chemicals, some of which are used in medical care (e.g. codeine for diarrhoea and stopping coughs, diamorphine and morphine for pain). However, taking zaleplon can increase the high from opiates (e.g. heroin, methadone, codeine), which might increase your dependence. You would also feel more drowsy.

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You should have no problems with "The Pill" and zaleplon.

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In the UK, Levonelle one step® is available and is usually known as 'the morning after pill'. It is taken to reduce the chances of becoming pregnant after unprotected sex or failure of a contraceptive method. In fact "Emergency Contraception" is the better term because it can be taken up to 72 hours (3 days) afterwards. It can be bought over-the-counter without a prescription from pharmacies. EllaOne® tablets (which may work up to 5 days afterwards) and a coil (Intra-uterine device) can also be used but must be prescribed by a Doctor.

If you are taking zaleplon, the usual dose should work if you follow the instructions carefully.

N.B. We accept that for religious, cultural or ethical reasons some people do not approve of, or agree with, the use of the "Morning After" pill. However, we have answered the question because it is one of the most often asked of NHS Direct in UK, and they suggested we include it.

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Several female functions such as menstrual cycle (e.g. your periods) are controlled by a hormone called prolactin. Prolactin in the body rises during and after pregnancy and this triggers the body to make breast milk. The amount of prolactin in the body is kept in control by one part of the brain uses dopamine as its chemical messenger. Some medicines (especially antipsychotics) block the effect of dopamine in the brain.

Luckily zaleplon doesn't seem to have any effect on dopamine in this part of the brain and so should not have any effect on your periods. If your periods are irregular or late, or you start leaking milk, then you should see your doctor about this to find the cause.

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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.

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Almost every medicine passes into breast-milk. The main questions are how much and if this is likely to have an effect on your baby. But also remember that being ill (e.g. depressed, manic, psychotic) may have more harmful and lasting effects on you and your child (such as bonding and behaviour e.g. Field, 2010) than a small amount of an effective medicine. If you have been taking a medicine while you are pregnant, you should usually be able to carry on as the amount in breast-milk is much less than the baby would have got while you were pregnant. It is usually thought to be fairly safe if the baby gets less than 10% of the mum's dose. But there may be times when although a medicine gets into breast milk the benefit may be worth the risk, so you should seek personal advice on this.

If you stop any medicine suddenly, some people can get discontinuation or withdrawal symptoms (see question above). If you have been taking a medicine during pregnancy, the same can sometimes happen to the baby when born. If the drug gets into breast milk, this can reduce the effect of suddenly not having the medicine (as well as coping with being in the big wide world too).

If you want to breast-feed there are some things you can do to reduce any risk:

• Nearly all medicines can be taken once a day. So, taking your daily dose just before the baby's longest sleep (often this will be at night) will reduce the amount the baby gets from the milk.

• Any side effects in the baby will be higher if the mum is taking a higher dose. So, try to take the lowest dose possible to still get an effect.

• Try not to take any medicines you don't really need. This includes any medicines you might buy over-the-counter

• Make sure your nurse, health visitor or doctor checks your baby for any side effects e.g. being extra sleepy, having colic, feeding problems, being floppy or poor weight gain. If there are any problems you might need to switch medicines or drop your dose a bit

• Hind milk (the second half of the feed) is likely to contain slightly more of any medicine than the first half

• Avoid new medicines if possible as there is less information about them and breast-feeding.

You must be extra careful of any medicines if your baby was pre-mature, or has kidney, liver, heart or brain problems.

We know that some zaleplon gets into breast milk but it is probably very low (less than 1% of the mum's dose, well below the 10% "safe" level). So, taking zaleplon is not recommended while breast-feeding. However, if you want to carry on with zaleplon you should talk about this to your doctor, nurse or health visitor because they will be able to do regular checks on your baby to make sure there are no problems e.g. poor feeding or extra drowsiness. Zolpidem might be a better alternative.

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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.

If you are taking any medicines, the rules about driving will depend on the country you’re driving in. Click on the links below for advice:

• Medicines and driving in the UK (England, Scotland, Northern Ireland and Wales)

• Medicines and driving in the Republic of Ireland

General advice on driving safely

If you want to drive, you should take sensible steps to reduce any risk. These could include:

• Avoid driving when you are tired or ill
• Do not drive after having any alcohol as this can make any 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, parking and petrol, you may actually find it is cheaper to get taxis and busses, and walk the short journeys.

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You should not need to have any tests to check on your zaleplon.

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The European Medicines Agency (EMA) is the body that approves medicines for use in the EU. Their website has a summary of the European Public Assessment Report (EPAR) for zaleplon (Sonata®). The EPAR is all the scientific stuff put in a readable way. It explains how and why the Committee for Medicinal Products for Human Use (CHMP) looked at the information on zaleplon and decided to allow it to be marketed ("granting a marketing authorisation" as the call it).  Click here to see their readable report.

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