Aripiprazole
A second-generation antipsychotic taken as a daily tablet or as an injection every month or two. It causes little weight gain, but inner restlessness is common.
At a glance
- Type
- Medicine: second-generation antipsychotic that partly activates dopamine receptors
- Used for
- Schizophrenia in adults and young people from 15, and mania in bipolar disorder
- Status
- Approved in Europe
- First used
- 2004, approved across the European Union
- How well it works
- About 34 in 100 people relapsed within 26 weeks, compared with 57 in 100 on placebo.1
- Evidence
- EstablishedHow evidence is rated
- Administration
- Tablets, once a day, with or without food. Also as a long-acting injection every month or every 2 months
- Starts to work
- Improvement can take several days to some weeks
- Common side effects
- Inner restlessness (akathisia), nausea, sleeplessness and anxiety, headache
- Checks needed
- Blood sugar in people with diabetes or its risk factors. Ask about new urges, such as gambling or binge eating
Clinical summaryFor health professionals
- Relapse prevention, 26-week placebo-controlled trial in stable patients: 34% relapsed on aripiprazole, 57% on placebo.
- Metabolic: among the mildest of 18 antipsychotics (Pillinger 2020). Weight gain of 7% or more over 26 weeks: 13% on aripiprazole, 33% on olanzapine.
- Akathisia in schizophrenia trials: 6.2% vs 3.0% on placebo. Prolactin is not raised and may fall.
- Dose: start 10 or 15 mg once daily; usual maintenance 15 mg; maximum 30 mg. No change needed for smokers.
- Halve the dose with strong CYP2D6 inhibitors (fluoxetine, paroxetine) or CYP3A4 inhibitors (ketoconazole); double it with carbamazepine.
- Ask specifically about new gambling, sexual, shopping or eating urges.
What it is
Aripiprazole is a second-generation antipsychotic. It treats schizophrenia in adults and in young people from the age of 15, and mania in bipolar disorder.1 It also comes as a long-acting injection: see long-acting injections (opens in a new tab).
How it works
Most antipsychotics block the dopamine D2 receptor. Aripiprazole works differently. It binds firmly to D2 receptors and activates them, but only partly, so it is called a partial agonist.2 In animal studies, it dampened dopamine activity where it was too high, and raised it where it was too low. It also partly activates the serotonin 5-HT1A receptor, blocks the 5-HT2A receptor, and has almost no effect on receptors for acetylcholine.1
Many antipsychotics raise prolactin, a hormone. Aripiprazole does not; in trials, it lowered prolactin more often than placebo did.3
History
When it was described in 2002, aripiprazole was presented as the first antipsychotic to work by partly activating dopamine D2 receptors rather than blocking them.2 It was approved across the European Union in June 2004.4 A monthly long-acting injection was tested in a trial that ran from 2008 to 2011.5
How well it works
| Outcome | Aripiprazole | Placebo |
|---|---|---|
| Relapsed | 34 | 57 |
In this trial, people whose symptoms were stable were randomly assigned to aripiprazole or to placebo.1 A Cochrane review also found fewer relapses with aripiprazole than with placebo, and fewer people leaving the trials early, though many trials lost a large share of their participants.3
In a year-long comparison with haloperidol, about as many people stayed well: 77 in 100 on aripiprazole against 73 in 100 on haloperidol. More people completed the year on aripiprazole: 43 in 100 against 30 in 100.1
For preventing relapse, trials found no clear difference between antipsychotics, so the choice depends mainly on side effects.6 When clozapine has not helped enough, adding aripiprazole is one of the better-supported options, though most of the trials were small.7
Side effects
| How common | Side effects |
|---|---|
| Common: 1 in 100 to 1 in 10 | Inner restlessness (akathisia), stiffness, tremor and other movement problems; headache; sleepiness and dizziness; sleeplessness and anxiety; nausea, vomiting, indigestion and constipation; producing too much saliva; blurred vision; tiredness; diabetes |
| Uncommon: 1 in 1,000 to 1 in 100 | Tardive dyskinesia, lasting involuntary movements; muscle spasms; restless legs; raised or lowered prolactin; raised blood sugar; depression; increased sex drive; a fast heartbeat; dizziness on standing up; double vision; sensitivity to light; hiccups |
| Frequency not known, reported after approval | Pathological gambling, binge eating, compulsive shopping and other impulse-control problems; suicidal thoughts and behaviour; neuroleptic malignant syndrome, a reaction with high fever and stiff muscles; seizures; serotonin syndrome; dangerous heart rhythms and sudden death; blood clots; inflammation of the liver or pancreas; weight gain or loss; low sodium; allergic reactions |
The side effects above are from the European product information.1 Three need particular attention:
- Restlessness. In schizophrenia trials, akathisia, an inner restlessness that makes it hard to sit still, affected 6.2 in 100 people on aripiprazole against 3.0 in 100 on placebo. In a year-long trial, movement side effects of all kinds were less common than with haloperidol: 25.8 in 100 against 57.3 in 100.1
- Weight. In a 26-week trial, 13 in 100 people gained at least 7 in 100 of their body weight on aripiprazole, against 33 in 100 on olanzapine.1 Among 18 antipsychotics, aripiprazole was one of those with the mildest effects on weight, blood sugar and blood fats.8
- New urges. Some people develop strong urges they cannot control, especially to gamble, but also to have sex, shop or eat. In some cases, the urges stopped when the dose was lowered or the medicine was stopped. Prescribers are advised to ask about such urges directly.1
Get medical help straight away for high fever with stiff muscles, sweating or confusion; signs of very high blood sugar, such as great thirst, passing a lot of urine and weakness; thoughts of harming yourself; or signs of a blood clot.1
Side effects can be reported to Lareb, the Dutch side-effects centre, to the FAMHP in Belgium, or to the manufacturer.
Administration
Aripiprazole tablets are taken once a day, with or without food. The prescriber sets the dose. Higher doses did not work better for most people, though some may benefit. Smoking does not change its level in the blood.1 The long-acting injection is given every month, or every 2 months.5,9
People with diabetes or its risk factors have their blood sugar checked regularly, and everyone is watched for signs of high blood sugar.1
Contraindications and cautions
The only reason not to use aripiprazole at all is an allergy to it or to an ingredient.1
It is not used for psychosis in dementia. In trials in older people with Alzheimer’s disease, deaths were about twice as common as on placebo: 3.5 in 100 against 1.7 in 100.1
Care is needed in people with heart or blood vessel disease, low or high blood pressure, seizures, swallowing problems, a family history of heart rhythm problems, or a risk of blood clots. Suicidal behaviour is part of psychotic illness and has sometimes occurred soon after starting or switching antipsychotics, so people at high risk are watched closely.1
Some antidepressants, such as fluoxetine and paroxetine, and some antifungal medicines raise the level of aripiprazole, so the dose is lowered. Carbamazepine, an epilepsy medicine, and St John’s wort lower it, so the dose is raised. Serotonin syndrome has been reported when it was combined with antidepressants that act on serotonin. Alcohol adds to the sleepiness.1
There is too little information on pregnancy, so aripiprazole is used only if the benefit clearly justifies the risk, and babies exposed late in pregnancy are watched after birth. It passes into breast milk, so breastfeeding is weighed with the prescriber. It can affect driving. It is not recommended for schizophrenia in children under 15.1
Check the patient leaflet, and ask the prescriber about your own situation.
Stopping
Across 30 trials with 4,249 people, 24 in 100 people who stayed on an antipsychotic relapsed within 7 to 12 months, against 61 in 100 who switched to placebo.10 Changes are best planned with the prescriber.
Alternatives
When restlessness or other movement side effects appear, the prescriber may lower the dose.1 Other antipsychotics have different side effects: olanzapine (opens in a new tab), for example, causes much more weight gain.8 When two antipsychotics have not helped enough, the next step is clozapine (opens in a new tab). Alongside medicine, NICE recommends CBT for psychosis (opens in a new tab) and family intervention (opens in a new tab).11
What we don’t know yet
- Why some people develop impulse-control problems on aripiprazole.
- Whether its milder effect on weight holds over many years.
- Who does better on a partial agonist than on a medicine that blocks dopamine.
