Copyright note for Mind factsheets: Both individuals and organisations are welcome to print and photocopy any complete factsheet from the 'Information' section of Mind's website. Organisations are free to distribute them to service users and colleagues, but must ensure they always use the latest version of the factsheet, as available on the website, at the time of distribution.
Introduction
Background to the drugs used for ADHD
How do the medicines work?
How are medicines used in ADHD?
Why is the use of these medicines controversial?
Screening before and during treatment
Side-effects
Methylphenidate
Atomoxetine
Dexamfetamine
Useful organisations
Further reading
References
The diagnosis of ADHD is controversial, and so is the treatment. Mind has produced a booklet that describes the condition: Understanding attention deficit hyperactivity disorder.
Although they are mentioned here, information about individual medicines, dosages and side-effects can also be found in the patient information leaflet that is provided with the medicine. You can also ask your pharmacist, specialist or family doctor or NHS Direct for more information, and these medicines are included in the Medicines Guides available at www.medicines.org.uk
Most of the information in this factsheet comes from the British National Formulary (BNF) and the datasheets for the medicines produced by the manufacturers and published in the electronic Medicines Compendium (emc.medicines.org.uk).
Stimulant drugs (amphetamines) have been used to treat ADHD since 1937. Studies show that they decrease physical activity and increase alertness, and improve performance in learning tasks. More recently, non-stimulant drugs have been developed for the treatment of ADHD.
Three medicines are licensed in the UK for the treatment of ADHD in children: methylphenidate and dexamfetamine, which are stimulants, and atomoxetine, which is not a stimulant. Methylphenidate and atomoxetine are licensed for use in children aged 6 years and over. Dexamfetamine is licensed for children aged 3 years and over. [1]
In its guidelines on the treatment of ADHD, the National Institute for Health and Clinical Excellence (NICE) recommends that medicines should not be used as the first treatment, except in the most severe cases, and that medicines should only be used in conjunction with social, behavioural and psychological treatments. [2] Methylphenidate or atomoxetine are suggested as the first choice of drug treatment. Dexamfetamine can be tried for children who do not respond to these.
Neither methylphenidate nor dexamfetamine is licensed for treatment of ADHD in adults. Atomoxetine is licensed for continuing treatment in adults who have been given it as children. A doctor may still prescribe these medicines for adults off licence.
When these medicines aren't suitable, don't work or have unpleasant side-effects, a doctor may prescribe antidepressants for ADHD in children. [3] These may also be useful when the doctor feels that depression in a child with a diagnosis of ADHD is more disabling than their ADHD symptoms. However, antidepressant medicines also have side-effects, and there are only a few that can be prescribed for children. For more detailed information, see Mind's booklet Making sense of antidepressants.
Tricyclic antidepressants should not be prescribed at the same time as a stimulant.
The way these medicines work for ADHD is not known, and the long-term effects of these medicines are not known.
Methylphenidate and dexamfetamine are related to amphetamine and are stimulants. They increase activity in the parts of the brain that control attention. It is possible that they boost communication between brain cells. Both are potentially addictive and are therefore Schedule II controlled drugs – in the same category as barbiturates and methadone.
Atomoxetine is not a stimulant, but acts in a similar way to some antidepressants. It is less likely to be addictive than the stimulant ADHD medicines and is less likely to be abused as a street drug.
Medicines are rarely used as the first treatment, because ADHD can often be managed successfully using behaviour management, social skills training and/or counselling or psychotherapy. Medication does not cure ADHD, but it can help the child to think more clearly, understand better, and feel calmer and more in control of themselves.
Stimulants should only be prescribed to children with severe and persistent symptoms and when a diagnosis of ADHD has been confirmed by a specialist. [4] The decision to use medicines should be made only after discussion with the parents or carers – and with the child if they are considered able. Treatment is started by the specialist but may be continued under the supervision of the family doctor.
Doctors need to calculate the right dose of the medicine, and should monitor the effect on the child. They should aim to give the child the lowest dose that provides some benefit. They may start by prescribing a low dose, and then increase it gradually if necessary.
Drug treatment should be stopped if a response is not seen within a month. If one medicine doesn't work, a different one can be tried. Some children take these medicines for 6 months, others for much longer, depending on how helpful they prove. Treatment often needs to be continued into adolescence, and sometimes into adulthood.
Drug treatment should be stopped for a short while every 1–2 years. These ‘drug holidays’ allow the doctor to assess the child’s condition and determine if drug treatment needs to continue, and may also allow catch-up growth if a child’s growth has been affected (see ‘Side-effects’ below). Medicines should not be stopped suddenly, however. The dose should be reduced gradually in order to avoid withdrawal symptoms.
Some experts have said that the use of medicines gives both children and their families a breathing space from the troubled behaviour of ADHD, and helps the parents to maintain a more loving relationship with their child. Others believe that children are being prescribed these medicines unnecessarily and fear that using them may mask emotional or other causes behind the behaviour, especially in very young children.
Dr Sami Timimi, a child and adolescent psychiatrist who is critical of the overuse of medicines in psychiatry, commented in response to the NICE guidance that NICE had cited no evidence that ADHD existed or that medication worked, despite producing guidance to support its use. NICE cited one study to support the use of methylphenidate which showed it worked in the short-term, but they did not consider the longer term results of the same study, which showed that after 3 years it made no difference. [5]
A study of children’s views found that they do not like taking stimulants, and they felt unhappy taking them, though they rarely complain to their prescribers. [6]
Prescribers should be alert to the possibility that these drugs may be passed on to others for whom they were not prescribed, for misuse.
As with any medicine, the medicines used to treat ADHD are not suitable for people who have some other medical conditions. These include epilepsy, tic disorders, Tourette’s syndrome, thyroid disorders, liver or kidney disease, glaucoma (raised pressure in the eye) and mental health problems. Before prescribing medicines for ADHD, the specialist should ask about existing medical conditions, psychiatric problems, and any family history of heart problems or sudden death. They should record blood pressure and heart rate, and may also take blood samples to check that the medicines do not have any effect on blood cells.
They should also ask about other medicines that are being taken, including over-the-counter and herbal medicines.
Your doctor should check heart function and blood pressure regularly throughout treatment and, for children, measure height and weight at regular intervals to check that they are growing normally.
Medicines used to treat ADHD can have unwelcome side-effects, particularly at the beginning of treatment. Children may have less appetite, lose weight and have problems falling asleep.
The effects of each dose of medicine usually last for three to five hours, and when it wears off there can be a rebound effect, with the problem behaviour returning in an extreme form.
ADHD medicine may make some children tearful and withdrawn. Reducing the dose often helps.
Although growth is not generally affected by medicines used for ADHD, it may be slowed in some children. This effect seems to be separate from the effect on appetite. Children’s growth should be monitored during treatment, and ‘drug holidays’ used to allow catch-up growth if necessary.
The long-term effect on children who are going through puberty is not known. [7]
An American study has suggested that all these medicines may be associated with psychotic symptoms or mania in a small number of children. [8] The investigators warn that if symptoms such as these are not recognised as a reaction to a medicine, the child may be given an additional diagnosis or a new diagnosis, together with an additional new medicine.
In February 2006, the Drug Safety and Risk Committee of the US Food and Drug Administration (FDA) recommended that ADHD stimulant treatments carry a ‘black box’ warning of the risk of sudden death, following a report listing 25 sudden deaths in adults and children between 1999 and 2003. Some of the patients had known heart disease, and the cautions for these medicines do include heart disease. [9] In the UK, atomoxetine is a ‘black triangle’ drug, which means that its adverse effects are closely monitored by the Commission on Human Medicines and the MHRA.
The additional cautions and side-effects relating to individual medicines are described below. Note that the side-effects listed are all those that might be related to the medicine: it does not mean that a child will necessarily experience all or any these effects. Some of the side-effects wear off after a few days as the body gets used to the medicine.
Brand names: Ritalin, Equasym, Medikinet, Concerta XL, Equasym XL, Medikinet XL
Dosage
The dosage used depends on the age and weight of the child. The maximum dose for children under the age of 6 years is 1.4mg/kg body weight; the maximum for a child over 6 years is 60mg/day.
Methylphenidate comes in tablet and capsule forms. Ritalin tablets contain a 10mg dose. Equasym and Medikinet tablets contain 5, 10 or 20mg. These tablets are usually taken twice a day.
The XL forms are modified-release formulations, which mean that the drug is released slowly and is active over a longer period than with the standard tablets. The advantage of the modified-release formulations is that children can take a single dose in the morning and do not need to take a controlled drug to school.
Concerta XL tablets contain either 18mg or 38mg, and are intended to have an effect for 12 hours. The 18mg XL tablet is equivalent to the 15mg normal-release (standard) formulation.
Equasym XL and Medikinet XL capsules contain doses of 10, 20 or 30mg, and are intended to have an effect lasting 8 hours. The contents of the Equasym XL and Medikinet XL capsules can be sprinkled on a spoonful of apple sauce and swallowed immediately without chewing.
The modified-release forms are not appropriate for people with recurrent indigestion or a narrowed gut as they may pass through the gut without being broken down.
When not to use methylphenidate
In addition to the general points above, methylphenidate should not be given to people with severe mental health problems (including anorexia and some personality disorders) or diseases affecting the heart or blood vessels. [10] It should be not be used in pregnancy, or while breastfeeding. If a patient becomes pregnant while taking methylphenidate they should contact their doctor or specialist as soon as possible.
If the child develops symptoms such as palpitations (irregular heart rate, felt as the heart racing or a fluttering feeling in the chest), fainting or breathlessness, their heart should be monitored.
Side-effects of methylphenidate
Very common (affecting 1 in 10 people or more): headache; nervousness and difficulty sleeping – reducing the dose or leaving out the afternoon or evening dose may help.
Common (affecting 1 in 10 to 1 in 100 people): nose and throat irritation; feeling anxious; sudden mood changes; stomach pain, feeling or being sick – these usually occur at the beginning of treatment (taking the medicine with food may help); dry mouth; dizziness; uncontrolled movements; irritability; cough; high temperature; weight loss.
Uncommon (affecting fewer than 1 in 100 people): reduced appetite; mental health problems including depression, psychotic symptoms and suicidal thoughts; sleepiness; shaking; blurred or double vision; fast heart rate, palpitations, changes in heart rhythm, changes in blood pressure (usually an increase); breathlessness; constipation; aching muscles and painful joints; rashes, itching, hair loss.
Rare (affecting 1 in 1,000 to 1 in 10,000 people): difficulty seeing, dilated pupils; excessive sweating.
Very rare: (affecting fewer than 1 in 10,000 people) hyperactivity, fits, muscle cramps, dance-like movements, tics; liver problems; blood disorders; heart pain; cold and numbness in fingers and toes (Raynaud’s phenomenon); problems affecting blood vessels in the brain.
Brand name: Strattera
Atomoxetine is not a stimulant, and though its effects on the brain are similar to those of stimulant drugs, it is less likely to be addictive or to become a drug of abuse.
Dosage
Adolescents weighing over 70kg and adults: 40mg/day for seven days, then increased according to response to usual maintenance dose of 80mg/day. Maximum dose 100mg/day.
Children over six years and adolescents weighing up to 70kg: 500 micrograms /kg per day for seven days, increased according to response to usual maintenance dose of 1.2mg/kg per day. Maximum dose: 1.8mg/kg per day. For example, for a child weighing 30kg, the starting dose would be 500 micrograms (which is the same as 0.5mg)/30kg = 15mg/day; the usual maintenance dose would be 1.2mg/30kg = 36mg/day; the maximum dose would be 1.8mg/30kg = 54mg/day.
The total daily dose can be given either all at once in the morning, or divided into two doses, one given in the morning and the second no later than early evening.
The medicine comes in capsule form. It is available in doses ranging from 10mg to 60mg.
When not to use atomoxetine
Atomoxetine should not be given to children under 6 years old. It should be avoided if possible during pregnancy, and should not be used while breast-feeding.
Side-effects of atomoxetine
Very common: (affecting 1 in 10 or more people): reduced appetite, stomach pain, feeling or being sick, headache, sleepiness; these effects may wear off as the body gets used to the medicine.
Common (affecting 1 in 10 to 1 in 100 people): loss of appetite, irritability, mood swings, inability to sleep, dizziness, constipation, indigestion, rashes, tiredness, increased blood pressure. Additional common side-effects that have been seen particularly in adults are hot flushes, problems urinating, inflammation of the prostate gland, groin pain, difficulties with erection and abnormal orgasm; menstrual problems.
Rare: (affecting 1 in 100 to 1 in 1,000 people): suicidal thoughts, aggression, unstable moods, early morning waking; fainting; shaking; migraine; dilated pupils; increased heart beat, palpitations; rashes, sweating, hot flushes, allergic reactions; loss of energy.
A few people have developed liver disease while taking this medicine. You should take your child to a doctor promptly if they have stomach pain, unexplained nausea (feeling sick), feeling unwell, dark urine, or jaundice (yellow tinge to the skin or whites of the eyes).
Adolescent girls and women taking this medicine should be monitored for painful periods, and boys and men for problems with erection and ejaculation.
Children taking atomoxetine may experience suicidal thoughts and behaviour [11] or psychotic or manic symptoms. If these symptoms occur, treatment should be discontinued. [12]
Brand name: Dexedrine
This medicine may be tried in children who do not respond to methylphenidate or atomoxetine.
Dosage
Dexamfetamine comes in 5mg tablets. The usual dose is 2.5mg/day for children aged under 6 years, and 5-10mg/day for those over 6 years. The usual maximum dose is 20mg/day, although some older children may be given up to 40mg/day.
When not to use dexamfetamine
In addition to the general advice given in the section ‘Screening before and during treatment’, dexamfetamine should not be given to people with excitability or agitation, a history of drug or alcohol abuse; or during pregnancy or breast-feeding.
It should be used with caution in people with slightly raised blood pressure or epilepsy (stop if fits [seizures] become more frequent or occur for the first time).
It should not be stopped abruptly, as this may induce depression or renewed hyperactivity. It may increase behavioural disturbances and thought disorder in children with a diagnosis of psychosis.
Side-effects of dexamfetamine
The relative frequency of the adverse effects of dexamfetamine is not published. The following side-effects are listed for this medicine: sleeplessness, panic attacks, restlessness, irritability and excitability, nervousness, night terrors, excitement, shaking, dizziness, headache, fits; becoming dependent on the medicine; sometimes psychosis, loss of appetite, stomach and gut symptoms, slowed growth in children, dry mouth, sweating, fast heart beat, palpitations/disturbed heart rhythm, raised blood pressure, dilated pupils and visual disturbances; heart muscle problems with long-term use; movement disorders, tics and Tourette syndrome; sexual problems; high temperature (see a doctor immediately).
AADD-UK
email: aadd.org@googlemail.com
web: www.aadd.org.uk
The Adult Attention Deficit Disorder UK provides information and support for adults with ADHD and related disorders.
ADDERS
tel: 0871 590 3693
www.adders.org
Provides support and information about ADHD in adults and children.
ADDiSS
Premier House, 112 Station Road, Edgware HA8 7BJ
tel: 020 8952 2800
email: info@addiss.co.uk
web: www.addiss.co.uk
The National Attention Deficit Hyperactivity Disorder Information and Support Service. Provides information, training and support for parents, people with ADHD, and professionals working in the fields of ADHD and related learning and behavioural difficulties. Website has a comprehensive resource centre.
Medicines guides
http://medguides.medicines.org.uk
Website provides information about medicines.
Mindinfoline
tel: 0845 766 0163 (Mon–Fri 9.00am to 5.00pm).
NICE
MidCity Place, 17 High Holborn, London WC1V 6NA
tel: 0845 003 7780
web: www.nice.org.uk
email: nice@nice.org.uk
The National Institute for Health and Clinical Excellence publishes independent guidance on the management and treatment of health issues.
MHRA
www.mhra.gov.uk
The role of the Medicines and Healthcare products Regulatory Agency is to safeguard public health by ensuring that medicines and medical devices work and are safe. The MHRA provides information about medicine licensing and administers the Yellow Card scheme for report side-effects of medicines.
Mind publications
The following booklets are available on Mind’s website at www.mind.org.uk or to purchase from Mind Publications on 020 8221 9666, from the online shop, or via publications@mind.org.uk
Making sense of antidepressants
Understanding attention deficit hyperactivity disorder (ADHD)
Understanding childhood distress
NICE publications
The following, written for parents and carers, can be obtained from NICE (via the website – see ‘Useful organisations’). The full versions of the guideline is also available via the NICE website.
Understanding NICE guidance: Attention deficit hyperactivity disorder
[1] Summary of product characteristics for Dexedrine, emc.medicines.org.uk
[2] NICE, 2009, Clinical guideline 72, Attention deficit hyperactivity disorder (ADHD), nice.org.uk/CG72
[3] British National Formulary for Children, 2008.
[4] British National Formulary 58, September 2009
[5] James, A, 2009, ‘ADHD drugs should not be first-line treatment’, Openmind, 154, p5.
[6] Moncrieff, J, 2009, A straight talking introduction to psychiatric drugs, PCCS Books.
[7] Moncrieff, J, 2009, A straight talking introduction to psychiatric drugs, PCCS Books.
[8] Cassels, C. et al, 2009, ‘Hallucinations, other psychotic symptoms in children linked to use of ADHD medications’, Medscape Medical News, 29 January.
[9] ‘FDA panel proposes black box warning for ADHD stimulants’, www.scripnews.com, No 3131, 15 February 2006.
[10] MHRA and CHM, 2009, Drug Safety Update, vol 2, issue 8, March.
[11] MHRA, 2006, ‘Updated warnings on the attention deficit hyperactivity disorder drug Strattera – information for healthcare professionals’, www.mhra.gov.uk, 16 February.
12 MHRA and CHM, 2009, Drug Safety Update, vol 2, issue 8, March.
This factsheet was written by Katherine Darton, Mind Information Unit, and updated October 2009.