TREATMENTS FOR LACK OF SLEEP (INSOMNIA)

Drugs known as HYPNOTICS or sleeping tablets

DRUG CLASS:- Non-benzodiazepines

Chloral hydrate capsules ('Noctec') were discontinued in 1997.

Chlormethiazole is changing name to clomethiazole.

What are they used for ?

Hypnotics make you sleepy and are used as a short term treatment of insomnia (or difficulty in getting to sleep or staying asleep). Chlormethiazole ('Heminevrin') can also be used to help agitation and restlessness, and to help alcohol withdrawal symptoms.

How do they work ?

Hypnotics make you sleepy and are used to help as a short term treatment of insomnia (or difficulty in getting to sleep or staying asleep). They help to calm you down and can make you sleepy, particularly if you are also anxious.

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. mania. Any causes of insomnia should, where possible, be identified and treated. The principles of "sleep hygiene" should also be taken seriously. The 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).

How should I take them ?

Tablets and capsules:

Tablets and 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 the throat. It is especially important that you take chloral hydrate with plenty of water or milk to avoid it upsetting your stomach.

Liquids:

Your pharmacist should give you a medicine spoon. Use it carefully to make sure you measure the correct amount. (Ask your pharmacist for a medicine spoon if you do not have one).

You should take chloral hydrate with plenty of water or milk to avoid it upsetting your stomach. Chloral hydrate syrup and chlormethiazole syrup ("Heminevrin") do not taste very nice. You could add fruit juices or squash to help this if you like.

When should I take them ?

Take your medication at bedtime as directed on the medicine label. Take it about half an hour before you want to go to sleep. Do not take another if you wake up later unless specifically told to do so. Zaleplon and zolpidem are different, as they have a rapid onset of action (possibly about 15 minutes), are short-acting and have 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 four hours.

How long will they take to work ?

They should start to work about half an hour to an hour after you take them. Your doctor may need to adjust the dose to suit you, if they do not work or make you too sleepy the next morning.

How long will I need to keep taking them for ?

This should be discussed with your doctor as people respond differently. They are safe drugs if used sensibly. They should be taken in as low a dose as possible for the shortest time possible. This would ideally be for no longer than about one month to help you get over your problems. If you need to take them for longer you should discuss this regularly with your doctor. Taking them only when required or every few days (e.g. alternate nights) can be a useful way to use these drugs safely.

It is not recommended that chlormethiazole is taken for longer than nine days if used to help alcohol withdrawal.

Are they addictive ?

Due to the effects that these drugs have on the brain they can sometimes produce a type of dependence (or addiction) in some people if taken regularly every night for more than about four to six weeks. Dependence or addiction means that you cannot manage without them because if you stop them you get "withdrawal" symptoms. These withdrawal symptoms could at worst include e.g. anxiety, tension, poor concentration, difficulty in sleeping ("rebound insomnia"), palpitations and sweating. This is unlikely at normal doses. These withdrawal symptoms may occur several days after stopping your drug. They may last for a few weeks but could go on for longer. If you have taken them for a long period of time your doctor may need to take you off your hypnotic by gradually reducing your dose over a period of time to prevent these effects. It is also true to say that many people suffer no withdrawal symptoms at all when they stop, even if they have been taking hypnotics for a while. You should thus make sure that you discuss your particular treatment with your doctor. For further discussion, click here.

If someone has a drink problem and is taking chlormethiazole to help the withdrawal symptoms it is not a good idea to take chlormethiazole for more than about nine days. They may then get hooked on the chlormethiazole.

Can I stop taking them suddenly ?

Chloral hydrate and zopiclone are probably best not stopped suddenly if you have been taking more than one dose regularly every day for more than about four to six weeks or more. If you do you may get some withdrawal effects as mentioned above. If you take them only when really necessary this is better than taking them continuously and can help stop you depending on them. You should discuss this with your doctor.

What should I do if I forget to take them ?

Take the dose as soon as you remember. If you take it too late at night you may feel more drowsy the next morning.

What sort of side-effects might occur ?

Table adapted from UK Psychiatric Pharmacy Group leaflets, with kind permission (www.ukppg.org.uk )

Do 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 they make me drowsy ?

Hypnotics are used to help you sleep and therefore should make you feel drowsy. You may however feel drowsy the next morning so you should not drive (see below) or operate machinery until you know how they affect you. You should be careful as they may affect your reaction times, even if you feel OK.

Will they cause me to put on weight ?

It is not thought that any of these hypnotics cause 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.

Will it affect my sex life?

These hypnotics do not have any known significant effects, unless of course you have already gone to sleep.

Can I drink alcohol while I am taking these ?

You should avoid alcohol while taking these drugs 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. The hypnotics can also increase the effects of alcohol. If you take alcohol the next day e.g. lunchtime this can also make you feel more drowsy than you would expect.

Are there any foods or drinks that I should avoid ?

You should have no problems with any food or drink other than alcohol (see above).

Will they affect my other medication ?

You should have no problems if you take other medications although a few problems can occur. Chloral hydrate can "interact" with some anticoagulants, and chlormethiazole can "interact" with cimetidine ("Tagamet" - a treatment for stomach ulcers). They can all also "interact" with other sleeping drugs and some antidepressants by increasing their sedative effects. This also does not necessarily mean the drugs can not be used together, just that you may need to follow your doctors instructions very carefully. Make sure your doctor knows about all the medicines you are taking. Some other medicines e.g. the painkiller co-proxamol ("Distalgesic") and some antihistamines (for hay fever) can make you drowsy. Combined with your hypnotic this could make you even drowsier. You should tell your doctor before starting or stopping these or any other drugs and ask your pharmacist before buying any medicine over the counter.

If I am taking a contraceptive pill, will this be affected ?

It is not thought that the contraceptive pill is affected by any of these drugs.

What if I want to start a family or discover I'm pregnant?

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:

Zaleplon is classified as "C" and zolpidem is "B". Zopiclone not classified as it is not available in the USA. There is no evidence of a teratogenic effect, and animal tests show a low risk of danger but you should still seek personal advice from your GP, who may then if necessary seek further specialist advice. Occasional use of a low dose would probably be of a low risk.

Chloral is classified as "C". There is no evidence of a teratogenic effect, but some problems have been reported and so you should seek personal advice from your GP, who may then if necessary seek further specialist advice. Clomethiazole is not classified, as it is not available in the USA. There is no evidence of a teratogenic effect, and animal tests show a low risk of danger but some problems have been reported and so you should seek personal advice from your GP, who may then if necessary seek further specialist advice.

Will I need a blood test ?

You will not need to have a blood test to check on your hypnotic.

Can I drive while I am taking them ?

These 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 your drug affects you do not drive or operate machinery. You should be careful as they may affect your reaction times, even though you may feel OK.

It is against the law to drive, attempt to drive or be in charge of a vehicle when unfit, either through illness or from the side effects of medication. Under UK law, it is the drivers responsibility to let the DVLA and insurance company know if you may be "unfit" to drive. If you do not, and you have an accident, it could effect your insurance cover. Your doctor will be able to advise you, and may wish to access the UK Driver and Vehicle Licensing Agency (DVLA) guidelines website, which has the current DVLA guidelines on anxiety/depression, psychotic disorders, mania and other conditions or for epilepsy. If your doctor advises you not to drive, and you continue to do so, the doctor can inform the DVLA directly, as he or she would be lawfully responsible were you to have an accident. Once told, the DVLA may wish to carry out an enquiry, but you are entitled to drive until there a decision is made.

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Information here is based on published data. References include the UK British National Formulary (BNF, published by the British Medical Association and Royal Pharmaceutical Society of Great Britain), Martindale (the extra pharmacopoea, published by RPSGB Pharmaceutical Press), Psychotropic Drug Directory (latest edition), Data Sheet Compendium (UK Manufacturers Data Sheets, published by the Association of British Pharmaceutical Industry), MicroMedex (an independent and extensive CD-ROM based drug information source), UK Psychiatric Pharmacy Group leaflets, Royal College of Psychiatrists advice and guidelines and the current medical literature. Thanks also to all those people who left e-mail comments, suggestions and requests, who have helped shape the site.