Drug treatment is not recommended for pre-school children with ADHD without a second opinion from an ADHD specialized practitioner. At the time of publication, lisdexamfetamine and dexamfetamine did not have SFDA approval. Informed consent should be obtained and documented.
Drug treatment is not indicated as the first-line treatment for all school-age children and young people with ADHD. It should be reserved for those with severe symptoms and impairment or for those with moderate levels of impairment who have refused non-drug interventions, or whose symptoms have not responded sufficiently to parent-training/education programmes or group psychological treatment where available.
Antipsychotics and tricyclic antidepressants are not recommended for the treatment of ADHD in children and young people.
Table 1
Name
Methylphenidate
Indication
- ADHD without significant comorbidity
- ADHD with comorbid conduct disorder
- In ADHD when tics, Tourette›s syndrome, anxiety disorder, stimulant misuse, or risk of stimulant diversion are present
Authorization Status (SFDA)
Authorized
Dosage
- Modified-release preparations are preferred because of:
- Convenience
- Improving adherence
- Reducing stigma (because the child or young person does not need to take medication at school)
- Reducing problems schools have in storing and administering controlled drugs
- Their pharmacokinetic profiles
- Initial treatment should begin with low doses of immediate-release or modified-release preparations consistent with starting doses in the Saudi National Formulary (SNF).
- The dose should be titrated against symptoms and side effects over 4 to 6 weeks until dose optimisation is achieved.
- Modified-release preparations should be given as a single dose in the morning
- Immediate-release preparations should be given in two or three divided doses
- Methylphenidate can be increased to 0.7 mg/kg per dose up to three times a day or a total daily dose of 2.1 mg/kg/day (up to a total maximum dose of 90 mg/day for immediate release; or an equivalent dose of modified-release methylphenidate
Special Precautions & Monitoring
- Height should be measured every 6 months.
- Weight should be measured 3 and 6 months after drug treatment has started and every 6 months thereafter.
- Height and weight should be plotted on a growth chart and reviewed by the healthcare professional responsible for treatment
- Healthcare professionals and parents or carers should monitor changes in the potential for drug misuse and diversion, which may come with changes in circumstances and age. In these situations, modified-release methylphenidate or atomoxetine may be preferred
- For people who have sustained resting tachycardia, arrhythmia or systolic blood pressure greater than the 95th percentile (or a clinically significant increase) measured on two occasions should have their dose reduced and be referred to a paediatrician.
- If psychotic symptoms (for example, delusions and hallucinations) emerge starting methylphenidate or dexamfetamine, the drug should be withdrawn and a full psychiatric assessment carried out. Atomoxetine could be considered as an alternative.
- Although there is no evidence that methylphenidate increases the risk of seizures, if seizures are exacerbated in a child or young person with epilepsy, or de novo seizures emerge following the introduction of methylphenidate, the drug should be discontinued immediately. Dexamfetamine may be considered as an alternative in consultation with a regional tertiary specialist treatment centre.
- If tics emerge in people taking methylphenidate, healthcare professionals should consider whether:
- The tics are stimulant-related (tics naturally wax and wane)
- Tic-related impairment outweighs the benefits of ADHD treatment
- If tics are stimulant-related, reduce the dose of methylphenidate; consider changing to atomoxetine, or stop drug treatment.
Table 2
Name
Atomoxetine
Indication
- When tics, Tourette’s syndrome, anxiety disorder, stimulant misuse, or risk of stimulant diversion are present.
- If methylphenidate has been tried and has been ineffective at the maximum tolerated dose, or the child or young person is intolerant to low or moderate doses of methylphenidate.
Authorization Status (SFDA)
Authorized
Dosage
- For those weighing up to 70 kg, the initial total daily dose should be approximately 0.5 mg/kg; the dose should be increased after 7 days to approximately 1.2 mg/kg/day.
- For those weighing more than 70 kg, the initial total daily dose should be 40 mg; the dose should be increased after 7 days up to a maintenance dose of 80 mg/day.
- A single daily dose can be given; two divided doses may be prescribed to minimise side effects.
- Atomoxetine may be increased to 1.8 mg/kg/day (up to a total maximum dose of 120 mg/day).
Special Precautions & Monitoring
- People treated with atomoxetine should be observed for agitation, irritability, suicidal thinking and self-harming behaviour, and unusual changes in behaviour, particularly during the initial months of treatment, or after a change in dose.
- For people who have sustained resting tachycardia, arrhythmia or systolic blood pressure greater than the 95th percentile (or a clinically significant increase) measured on two occasions should have their dose reduced and be referred to a paediatrician.
- If seizures are exacerbated in a child or young person with epilepsy, or de novo seizures emerge following the introduction atomoxetine, the drug should be discontinued immediately. Dexamfetamine may be considered as an alternative in consultation with a regional tertiary specialist treatment centre.
Table 3
Name
Dexamfetamine or
Lisdexamfetamine
Indication
- Dexamfetamine should be considered (if available) in children and young people whose ADHD is unresponsive to a maximum tolerated dose of methylphenidate or atomoxetine.
Authorization Status (SFDA)
At time of publication, not approved by SFDA.
Dosage
- Initial treatment should begin with low doses
- The dose should be titrated against symptoms and side effects over 4 to 6 weeks
- Treatment should be given in divided doses increasing to a maximum of 20 mg/day
- For children aged 6 to 18 years, doses up to 40 mg/day may occasionally be required
Special Precautions & Monitoring
- Healthcare professionals and parents or carers should monitor changes in the potential for drug misuse and diversion, which may come with changes in circumstances and age. In these situations, modified-release methylphenidate or atomoxetine may be preferred
- For people who have sustained resting tachycardia, arrhythmia or systolic blood pressure greater than the 95th percentile (or a clinically significant increase) measured on two occasions should have their dose reduced & be referred to a paediatrician.
- If psychotic symptoms (for example, delusions and hallucinations) emerge starting methylphenidate or dexamfetamine, the drug should be withdrawn and a full psychiatric assessment carried out. Atomoxetine could be considered as an alternative.
- If tics emerge in people taking dexamfetamine, healthcare professionals should consider whether:
- The tics are stimulant-related (tics naturally wax & wane)
- Tic-related impairment outweighs the benefits of ADHD treatment
- If tics are stimulant-related, reduce the dose of dexamfetamine; consider changing to atomoxetine, or stop drug treatment.
Table 4
Name
Bupropion, Clonidine, Modafinil
Imipramine
Indication
In children and young people whose ADHD is unresponsive to methylphenidate, atomoxetine and dexamfetamine
Authorization Status (SFDA)
(Off-label)
Dosage
–
Special Precautions & Monitoring
- The use of medication unlicensed for ADHD should only be considered in the context of tertiary services.
- Informed consent should be obtained and documented.
- A cardiovascular examination and electrocardiogram (ECG) should be carried out before starting treatment with clonidine in children or young people with ADHD.