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Review
Pharmacological treatments for ADHD
Caroline Parker MRPharmS, MCMHP in association with

Pharmacological
treatments for ADHD
In the fourth of this series on the major psychiatric drug groups, Caroline Parker discusses the
use of drug treatments in the management of attention deficit hyperactivity disorder (ADHD),
including their indications, efficacy, adverse effects and recommended dosing regimens.

A
Attention deficit hyperactivity disorder (ADHD) and The aim of any medication is to help children and
the very similar hyperkinetic disorder (HKD) are the adolescents with ADHD to concentrate, to help them
most common psychiatric disorders that affect chil- to be calmer, less hyperactive and more focused.
dren. They are known as neurodevelopmental disor-
ders. The exact causes are unknown but it is thought Evidence base supporting pharmacotherapy
that there is a complex interaction between a range of The 2008 NICE Clinical Guidelines2 on the manage-
genetic, environmental and biological factors.1 ment of ADHD, were based on the 2004 NICE
Worldwide, two diagnostic systems are used to Technology Appraisal of methylphenidate, atomoxe-
clinically diagnose psychiatric disorders: tine and dexamfetamine for ADHD in children and
• American Diagnostic and Statistical Manual of adolescents, 3 and the 1998 European Clinical
Mental Disorders 4th edition, American Psychiatric Guidelines (updated in 2004).4
Association, 2000 (DSM-IVR) Medication is not indicated as the first-line treat-
• International Classification of Diseases 10th edition, ment for all children with ADHD. Medication should
WHO 1992, (ICD-10). be reser ved for those with severe and impairing
For conditions related to hyperactivity and inatten- symptoms, and for those with more moderate impair-
tion in children, these systems use slightly different ment who have refused or not responded to non-phar-
diagnostic criteria and terms: macological treatments. Medication should always be
• DSM-IVR: Attention deficit hyperactivity disorder offered as part of a comprehensive treatment plan
(ADHD) that includes psychological, behavioural and educa-
• ICD-10: Hyperkinetic disorder (HKD). tional advice and interventions.2 Medication should
The latter system is routinely used in the UK, and be initiated by a specialist in ADHD but may be con-
hyperkinetic disorder has more stringent diagnostic tinued by GPs under a prescribing shared care agree-
criteria. However, as the term ‘ADHD’ is used more ment.2 The most commonly used first-line medication
commonly in the literature, for convenience and in line is methylphenidate; other agents are atomoxetine,
with the National Institute for Health and Clinical and much less frequently, dexamfetamine. Rarely, and
Excellence (NICE) Guidelines,2 this term will be used only under the care of tertiary services, other medi-
throughout this article to refer to a diagnosis under cines such as imipramine (a tricyclic antidepres-
both systems. sants), clonidine, bupropion and modafinil may be
The core symptoms of ADHD are: considered.2 As there is no definitive data to suggest
• Inattention - children may find it hard to pay atten- greater ef ficacy of any licensed medicine over
tion, and have difficulty concentrating. They may be another1-5 the prescribers’ choice of medication for
easily distracted and may skip from task to task. They an individual patient should be guided by the follow-
may be forgetful, disorganised and find it hard to set- ing considerations:2
tle down to do a task. • any co-morbid conditions (such as epilepsy,
• Hyperactivity - children may be restless or fidgety, Tourette syndrome, tics)
are often talkative and noisy. • medicine side-effect profiles
• Impulsivity - children may speak or act without • specific practical issues regarding compliance, eg
thinking, may frequently interrupt conversations and dif ficulties in storing/taking/administering a
talk out of turn. They may find it difficult to wait their lunchtime dose when at school
turn, for example in a game or a queue. • potential for misuse and/or diversion
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Review
Pharmacological treatments for ADHD

• Preferences of the child and carer. nists or re-uptake inhibitors.1 However the exact role
Treatment should be with a single medication – of dopamine and noradrenaline neurotransmission in
although sometimes is it necessary to combine differ- causing ADHD is largely unknown. Methylphenidate
ent formulations of methylphenidate. blocks the reuptake of noradrenaline and dopamine into
Methylphenidate and dexamfetamine are mild presynaptic neurones, and increases their release into
CNS stimulants (also known as psychostimulants). the extraneuronal space.19 Atomoxetine is a highly
Available since the 1950s, methylphenidate, often selective and potent blocker of the presynaptic nora-
known by the brand name Ritalin, has been the main drenaline transporter, thereby enhancing the activity
and commonly used medication for ADHD in the UK of noradrenaline. It has minimal effect on other neuro-
since the 1980s. The non-pharmaceutical industr y transmitter receptors or transporters.
sponsored Multimodal Treatment Study of Children
with ADHD (MTA) studies robustly demonstrated the Routes of metabolism
efficacy of methylphenidate alone, and in conjunction Atomoxetine is metabolised by CYP2D6. Poor
with behavioural therapy.6-8 metabolisers of CYP2D6 will have higher levels of ato-
In more recent years a range of extended-release moxetine, and are therefore at a greater risk of side-
formulations have been brought to the market that ef fects, compared with patients with a functional
allow for once daily9,-11 rather than twice or thrice daily enzyme. Approximately 7 per cent of Caucasians are
dosing. This has a significant impact on treatment, as CYP2D6 poor metabolisers, meaning that they have a
previously the requirement for frequent doses often genotype corresponding to a non-functional CYP2D6
presented a practical barrier to effective medicine use. enzyme. Poor metabolisers should be prescribed
Dexamfetamine is used far less often, as it is com- lower doses.20
monly perceived to have a greater abuse potential than
methylphenidate. It is only available in an immediate- Pharmacokinetic parameters
release formulation warranting multiple daily dosing.12 There a several different controlled-release formula-
Atomoxetine was the first non-psychostimulant tions of methylphenidate. It is impor tant that pre-
to have demonstrated efficacy13-17 to be licensed for scribers understand the differences between these
the treatment of ADHD in the UK (2004, and in the formulations before prescribing, as they have a pro-
US since December 2002). In a randomised, double- found effect on the dosage regimen. Refer to Table 1.
blind, placebo-controlled study in adults the abuse-
potential of atomoxetine and placebo were Onset of action
compared. Atomoxetine was not associated with Unlike most medicines used within psychiatr y, the
behaviour suggesting stimulant or euphoriant prop- psychostimulants (methylphenidate and dexamfeta-
erties,18 consequently it is not classified as a con- mine) usually start having an effect within a few hours,
trolled drug. This lack of abuse potential may be of although they can take a week to full ef fect.
particular use in situations where there is concern Atomoxetine has a much slower onset of action, and
that the patient and/or members of their family may the initial dose titration may take a several weeks.13,20
potentially be misusing medicines or diverting sup-
plies for misuse.2 Dosing regimens
Previously some older medicines such as Once-daily modified-release formulations of
imipramine and clonidine have been used, and occa- methylphenidate are used commonly for ongoing
sionally these are still used in more resistant cases treatment as these formulations confer huge practical
where methylphenidate, dexamfetamine and atom- advantages regarding the frequency of doses com-
oxetine have failed. However, these have significant pared to the older immediate-release formulation,
side-effect burdens, are unlicensed for this indica- which required twice or thee-times daily dosing. The
tion and therefore should only be initiated by spe- first, or only, daily dose of methylphenidate is usually
cialists in ter tiar y ser vices, and are not given before breakfast, in order to allow it to begin to
recommended for routine use. Similarly, bupropion be released and take effect as the child gets up and
and modafinil may be used.2 starts their morning routine.19 If the effect begins to
wear off in the early evening, ie around 6pm, this can
Pharmacology result in rebound hyperactivity, disturbed behaviour
Mechanism of action and/or an inability to go to sleep. A small dose of an
All medicines known to treat ADHD act on dopamine immediate-release methylphenidate formulation late
and/or noradrenaline neurotransmission, either as ago- in the day may help.21
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Review
Pharmacological treatments for ADHD

Active agent Brand name Dosing frequency and release profile Formulation28 Comments

Methylphenidate Concerta XL Once daily dosing.The overcoat dissolves Modified-release Tablets must not be chewed or
hydrochloride immediately,providing initial peak concentrations tablets opened.The hard plastic tablet
in about 1-2 hours. Methylphenidate is then 18mg, 27mg, 36mg shell is excreted in faeces
gradually released from two internal layers over unchanged.
the next few hours. Second peak plasma An 18mg tablet is considered
concentrations are achieved at about 6-8 hours. to be equivalent to a daily
Once-daily Concerta XL gives serum levels dose of 15mg of immediate-
comparable to three times a day immediate- release methylphenidate.
release methylphenidate Schedule 2 Controlled Drug

Equasym XL Once daily dosing. 30% of the dose is released Modified-release Capsules and contents must
immediately, 70% of the dose is in a modified- capsules not be crushed or chewed.
release compartment designed to deliver 10mg, 20mg, 30mg Capsule contents can be
therapeutic plasma levels for a period of sprinkled on a tablespoon
approximately 8 hours of apple sauce, then
swallowed immediately.
Schedule 2 Controlled Drug

Medikinet XL Once daily dosing. 50% of the dose is released Modified-release Capsule contents can be
immediately, 50% is released approximately capsules sprinkled on a tablespoon
three hours later. Delivers therapeutic plasma 10mg, 20mg, 30mg, of apple sauce or other
levels for approximately 8 hours. Once daily 40mg similar soft food (then
Medikinet XL gives serum levels comparable to swallowed immediately
twice daily administration of immediate-release without chewing).
tablets Schedule 2 Controlled Drug

Immediate-release Twice or three times daily dosing, eg at Scored tablet Maximum plasma
formulations: breakfast and lunch, and early afternoon 5mg, 10mg, 20mg concentrations are reached
Ritalin, Equasym about 1-2 hours after admin-
Medikinet istration.Tablets can be halved.
Also as generics Schedule 2 Controlled Drug

Dexamfetamine Dexedrine Usually twice daily dosing. Scored tablets, 5mg Schedule 2 Controlled Drug
Immediate-release

Atomoxetine Strattera Once daily; if not tolerated, it may be given Capsules  CSM close surveillance.
twice daily 10mg, 18mg, 25mg, Capsules should not be
40mg, 60mg, 80mg opened.Atomoxetine is an
ocular irritant

Clonidine Catapres Twice daily dosing Scored tablets Unlicensed indication

100µg, 300µg

Imipramine Generic Twice daily dosing Coated tablets, Unlicensed indication. Should
10mg, 25mg not be used with psycho-
stimulants. Metabolism of
tricyclics is possibly inhibited
by methylphenidate
Table 1. Summary of preparations12,19,20,21,26,27,32
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Pharmacological treatments for ADHD

Side-effect Suggested Management Methylphenidate Atomoxetine

Abdominal pain This is most common at the start of treatment. It usually settles after Common Very common
a couple of weeks.The dose can be taken with or after food

Appetite decreased This is most common at the start of treatment. It usually settles after a Common Very common*
couple of weeks

Blurred vision Patients should be advised not to drive (if applicable) Rare n/a

Constipation Patients should be advised to maintain a good fluid intake, a fibrous diet, n/a Common
and exercise regularly

Dizziness Patients be advised to avoid standing up quickly. If they feel dizzy, they Common Common
should try to lie down. Patients should be advised not to drive (if applicable)

Drowsiness Patients should be advised not to drive (if applicable) Common Common*

Dry mouth Patients should be advised that frequent sips of water, sugar-free boiled Common n/a
sweets, chewing gum or citrus fruits will often help

Growth slower than normal Growth is generally not affected, but it is advisable to monitor during treatment28 Rare n/a

Headache Patients should be advised to try a mild analgesic such as paracetamol Common n/a

Indigestion Patients should be advised to try sleeping propped up on pillows n/a Common

Movement disorders This should be assessed. It may be appropriate to change the medicine Common n/a

Nausea and vomiting Patients should be advised to try taking the dose with or after food.This is Common Very common
most common at the start of treatment

Nervousness and insomnia This is most common at the start of treatment. It usually settles after a Very common n/a
couple of weeks. If it continues it may be appropriate to reduce the dose
or change the dosage regimen

Palpitations and tachycardia These should be investigated, and the treatment may need to be discontinued Common Uncommon

Postural hypotension The patient should be advised to try to sit or stand up slowly. If patient n/a Uncommon
feels dizzy, they should be advised not to drive (if applicable)

Rashes and pruritus If the rash is severe and itchy or does not go away, it may be necessary Common Common
to stop the medicine

Weight loss with loss of appetite Weight gain and growth should be monitored. If there is a notable lack of n/a Common
weight gain and growth consider stopping the treatment

Very common: >10 per cent; common: 1-10 per cent; uncommon: 0.1-1 per cent; rare: 0.01-0.1 per cent; n/a: not applicable/not a reported adverse reaction
* Thought to be dose related14

Table 2. Comparative adverse reactions2,3,12,19,20,21,26-28,32

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Pharmacological treatments for ADHD

If there is no clinical response to treatment at ade-

Box 1. The Children s National Service Framework: 10 markers of good practice
quate doses after a month, it should be discontinued.
For those clinically responding, treatment should be
Standard 9: Mental Health and psychological wellbeing of children and young people35 continued as long as there is a meaningful response,
‘All children and young people, from birth to their 18th birthday, who have mental health but the need for treatment should be re-assessed annu-
problems and disorders, have access to timely, integrated, high-quality, multidisciplinary ally.2 This assessment often involves a break in treat-
mental health services to ensure effective assessment, treatment and support, for them and ment for a number of weeks (usually in the school
their families.’ holidays) during which time any re-emerging symp-
toms are assessed. Such treatment breaks are more
easily conducted with the psychostimulants due to
Standard 10: Medicines for children and young people36
their rapid onset of action. A treatment break is much
‘Children, young people, their parents or carers, and healthcare professionals in all settings harder to initiate with atomoxetine, as it takes much
make decisions about medicines based on sound information about risk and benefit.They longer to achieve therapeutic action.
have access to safe and effective medicines that are prescribed on the basis of the best
available evidence.’ Safety warnings
In 2005, the Committee for Safety of Medicines (CSM)
Atomoxetine is usually given once a day in the issued guidance following reports of rare, but some-
morning, but if this is not tolerated this can be divided times severe hepatic disorders associated with atomox-
into two doses. For a comparison of the various med- etine use.24 Atomoxetine should be discontinued in
ications, refer to Table 1. patients with jaundice or laboratory evidence of liver
injury, and should not be restarted. Children and car-
Adverse effects ers should be advised how to recognise the symptoms
Methylphenidate and atomoxetine are generally well of hepatotoxicity, eg abdominal pain, unexplained nau-
tolerated (for a summary of effects refer to Table 2). sea, malaise, darkening of the urine, jaundice. As this is
The side-effects of methylphenidate have been well a rare and idiosyncratic reaction, routine monitoring of
established over its decades of use and the most com- liver function tests is not recommended.2,24 Later in
mon adverse effects include nervousness/irritability 2005, the CSM also issued guidance regarding concerns
and insomnia, headaches, abdominal pain and discom- of an increased risk of suicidal thoughts and behaviour
fort, which may cause decreased appetite, nausea, in patients taking atomoxetine.25 Patients should be
vomiting and diarrhoea, dry mouth and dizziness. In monitored for signs of depression, suicidal thoughts or
clinical trials of atomoxetine, adverse effects were rel- suicidal behaviour and referred for appropriate treat-
atively common, but generally not serious.5,13-17,22 ment if necessary. Patients and carers should be warned
Increasing doses were associated with statistically sig- of these risks and advised to watch for any worsening
nificant small increases in systolic BP and pulse. symptoms of irritability or agitation, suicidal thoughts or
However this small increase may not be clinically sig- behaviour or other unusual changes in behaviour.
nificant,14,15 and no effect has been noted on cardiac
conduction, repolarisation or rhythm.17 Use in special populations
Adults
Duration of t reatment A diagnosis of ADHD requires that symptoms were pres-
Although administered daily, it is important that the ent during early childhood (usually by five or six years
psychostimulants (methylphenidate and dexamfeta- of age). Commonly the symptoms ease as the child
mine) are used in a manner that allows serum levels to enters adolescence and consequently treatments may
diminish to zero within the 24-hour cycle, thereby not be reduced and stopped. For other children, the symp-
inducing tolerance and addiction. Although parents and toms continue and therefore treatments need to be con-
carers often express concern that their children may tinued into adolescence, and possibly even into
develop a drug misuse habit, there is data to demon- adulthood.1 There is a growing evidence base to support
strate that children with ADHD who are not treated the use of methylphenidate and atomoxetine29-31 in
with medicines are at a significantly increased risk of adults with ADHD. However, this data is not as robust
any substance misuse disorder in the future, compared as that for children and consequently current guidelines
with those without ADHD. Those with ADHD who are for the treatment of adults1,2,4 are largely based on
successfully treated with medication are at a signifi- expert consensus opinions. In general, as a patient with
cantly reduced risk of a future substance misuse disor- a diagnosis of ADHD turns 18 years old, the treatment
der compared with untreated ADHD patients.23 should continue as before, with periodic assessments
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Pharmacological treatments for ADHD

and reviews. For adults without a childhood diagnosis

of ADHD, the situation is less clear and open to debate.1 Box 2. Key information for patients
It can be extremely difficult to diagnose ADHD retro-
spectively based on symptoms experienced in childhood, • Children and their carers should ensure that all medicines are stored safely and securely,
and both existing diagnostic criteria are not adapted to whether at home, school or elsewhere
diagnose ADHD based on symptoms presenting in adult-
• Medicines should be kept out of reach of children for whom they are not prescribed
hood. Currently in the UK, no medicines are licensed
• Methylphenidate and atomoxetine can help children and young people with ADHD to
for the treatment of ADHD in adults.32 Therefore any
medicines that are prescribed for this are off-licence. concentrate, and focus more clearly on what they are doing, and help them to be calmer,
less hyperactive and more focused
Pre-school children • All medicines should be taken following the doctors’ instructions, and atomoxetine
Medications for the treatment of ADHD are not rec- particularly needs to be taken regularly and every day for it to be of any benefit
ommended2 nor licensed12,19,20,21,26,27 for use in pre- • Do not chew or crush tablets or pills unless you have confirmed with your pharmacist or
school children, as the diagnosis cannot be definitively doctor that it is OK to do so
clarified in this age group. • If a child is having difficulty in swallowing the tablets or pills, ask your pharmacist for advice
about other formulations and ways of taking it
Future developments
There are few new medicines in development for the
treatment of ADHD. However, there is great attention medicines in the management of ADHD. It is now
towards developing further new extended-release and available in a range of once-daily formulations that
controlled-release formulations of the currently available have different release profiles allowing the prescribers
medications. Several such formulations are currently to tailor treatment to the individual child.
available in the USA but not in the UK, for example: Methylphenidate is effective in most children with
• Adderall immediate-release and Adderall XL (Shire ADHD. If it is not clearly seen to be working, it should
Pharmaceuticals) - A mixture of amphetamine salts be stopped and the situation reviewed. All treatments
and dexamfetamine should be reviewed annually, or sooner if clinical indi-
• Daytrana (Shire Pharmaceuticals) - a daily patch cated. Atomoxetine, a non-stimulant, is a suitable alter-
releasing methylphenidate for transdermal absorption. native for children and young people where there is
• Dexmethylphenidate (Focalin XR, Novartis) - Single concern about misuse or diversion. Parents and carers
isomer form of once daily methylphenidate. should be reassured that treating childhood ADHD
• Lisdexamfetamine dimesylate (Vyvanse, Shire) with psychostimulants does not lead to later life sub-
once-daily - A prodrug of dexamfetamine. stance misuse behaviour.
Other agents that have undergone research include:
• Guanfacine (Shire) - A selective alpha2-adrenocep- Caroline Parker, Consultant Pharmacist, Adult
tor agonist, ie a non-stimulant. Submitted to USA FDA Mental Health Services, Central and North West
for approval.33,34 Has shown mixed results regarding London NHS Foundation Trust
efficacy.
• Modafinil (Provigil, Cephalon) - Currently licensed References
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Review
Pharmacological treatments for ADHD

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primheconferences
the leading primary care conferences for mental health
PRIMARY
CARE
M E N TA L
H E A LT H
& E D U C AT I O N

integrated primary mental 23rd September 2009

09:00 til 16:30
health care making it happen University of Warwick Arts Centre
CV4 7AL
Ruby Wax has agreed to be guest-speaker at the pre conference dinner.
Key note speakers include; Dr Steve Field, John Seddon & Dr George Tadros. conference fees
places can be booked via our
workshops website at www.primhe.org.uk
Balint and how it harmonises the primary/secondary care interface (1a)
conference only £150 + VAT
'A pain in the neck?' (1b)
conference + B&B £200 + VAT
Psychology of terrorism (1c)
Primary care a worldwide perspective (1d) conference + B&B +
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Medically unexplained symptoms (2a)
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Mental and physical health needs of the
prison population. Facts and practicalities (2b)
Sick Doctors – Looking after our own (2c)
Service redesign innovations that work (2d)

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