Risperidone and olanzapine: restrictions on use

This factsheet should be read in conjunction with factsheet 408 Dementia: drugs used to relieve behavioural symptoms

Information for care staff

Background

The Committee on Safety of Medicines (CSM) has decided that the neuroleptic drugs risperidone and olanzapine should no longer be prescribed for the treatment of behavioural symptoms in people with dementia.

Why has the CSM published this guidance now?

Evidence from a number of placebo-controlled studies of risperidone for the treatment of agitation in people with dementia has shown that people are more likely to have a stroke if prescribed risperidone. There is less information available for olanzapine, but the risk appears to be similar.

The CSM believes that the risk of stroke when using risperidone and olanzapine is at an unacceptable level in people with dementia and that these drugs should not be prescribed.

Are other neuroleptic drugs a suitable alternative?

Neuroleptics (also known as major tranquillisers) are sedative drugs used to treat schizophrenia and prescribed widely to people with dementia. People with dementia should not be prescribed neuroleptic drugs unless absolutely necessary. These drugs can accelerate cognitive decline and impair quality of life.

There is very limited evidence available on the use of neuroleptics for people with dementia and most of it is associated with harmful side-effects, such as parkinsonism, drowsiness, stiffness and falls (with related fractures). The long term use of any neuroleptic in people with dementia is not advisable and should only be considered as a last resort.

Neuroleptic drugs are usually divided into those called 'typical neuroleptics' (older drugs such as haloperidol and chlorpromazine) and 'atypical neuroleptics' (newer drugs such as risperidone, olanzapine, quetiapine and amisulpiride). There are no published studies comparing newer drugs with a placebo, other than for risperidone and olanzapine.

Overall, neuroleptic drugs have modest effects. Trials show that, over four to 12 weeks, 60 per cent of people respond to a neuroleptic, while 40 per cent of people respond to a placebo. However, there is no evidence of ongoing benefit. None of these drugs have a specific licence for treating behavioural symptoms in people with dementia. Doctors can prescribe neuroleptic drugs for people with dementia 'off licence'.

What should happen to someone with dementia who is taking risperidone or olanzapine?

It is recommended that the person stops taking the drug for a trial period of two to four weeks and that they are not prescribed an alternative during this time. This allows adequate time to see whether extra treatments are necessary or needed.

Can a person with dementia be taken off risperidone or olanzapine immediately?

If the person is on a low dose of risperidone or olanzapine, they can stop taking it immediately. If they are on a high dose, the drug should be phased out over two to three weeks. Advice from a GP should be sought.

There is evidence from three withdrawal trials that when a person with dementia stops taking a neuroleptic drug their behavioural symptoms do not get significantly worse. In these studies, 70 per cent of people needed no further drug treatment.

What if a person with dementia continues to be distressed or a risk to themselves of others?

In the small number of individuals who experience some worsening of symptoms, treatments that don't involve drugs can be very effective. These should always be considered first for people with dementia, and can include very simple strategies such as:

More detailed and individualised assessments of the person's personality and behaviour
Removing obvious triggers for symptoms - noise, pain, for example
Physical presence: spending time with a person
Recreational and social activities and therapies that help structure and give meaning to the day
Alternative therapies. Four placebo-controlled trials suggest that aromatherapy with lemon balm or lavender oil may be an effective treatment for symptoms.

The key to reducing, improving and managing behavioural symptoms is good person-centred care, fully utilising and developing the interpersonal skills of staff in the right environment. Training materials are available from the Alzheimer's Society, which may be helpful.

Drugs for treating people with early to moderate Alzheimer's disease, such as Aricept, Exelon and Reminyl, may improve some behavioural and psychiatric symptoms. These drugs are much better tolerated than neuroleptics and have the advantage of improving cognition and general functioning in many people. Emerging evidence suggests that they may also help behavioural and psychiatric symptoms in vascular dementia, severe Alzheimer's and dementia with Lewy bodies. Aricept, Exelon or Reminyl are probably the preferred options if drug treatment is being considered.

The antidepressant trazodone and anti-epileptic medication such carbamazepine and sodium valproate may be helpful in some people with dementia but they can also cause drowsiness and increase falls.

Further treatment with neuroleptic or sedative drugs should only be considered if monitoring and other treatments have been unsuccessful and the behavioural symptoms are resulting in risk or leading to distress. There is little evidence for the usefulness of these types of drugs for people with dementia and they are associated with a high risk of falls.

Can risperidone and olanzapine still be prescribed?

Short term use of the drugs (up to a few weeks) is allowed under specialist supervision for the treatment of severe and distressing acute psychotic symptoms in people with dementia.

These drugs can still be used to treat other groups of older people (including those with acute confusional states), although caution is required in older people at risk from stroke.

What about people with dementia with Lewy bodies (DLB)?

Neuroleptic drugs are potentially very dangerous in people with DLB. They can cause a severe sensitivity reaction that results in severe symptoms of Parkinson's disease, unstable temperature and blood pressure control and breakdown of muscle tissue. This can cause death.

There is evidence that cholinesterase inhibitors (Aricept, Exeleon, Reminyl) can improve psychiatric and behavioural symptoms in these individuals, and should be the treatment of first choice. Given the complexities involved in treating DLB, people should be referred to a specialist.

What questions should you ask the doctor?

It is important to establish whether the person is being prescribed a neuroleptic drug and, if so, when the treatment is going to be reviewed and when it is likely to be stopped. Treatment should be reviewed regularly and should probably be stopped within three to six months for most individuals. In these circumstances, it is very important to remind the doctor when treatment reviews are due.
If a medication is prescribed for behavioural symptoms in someone with dementia, it is very important to get a clear explanation of why this is necessary and what other treatment approaches have been tried first. Showing your awareness of other treatment approaches and discussing alternatives with the doctor may be very helpful.

Alzheimer's Society