Why Prescribe ADAFLEX
Prescribing ADAFLEX Aligns With NICE Guidance1,2
Prescribing ADAFLEX Aligns With NICE Guidance on Melatonin Use for Insomnia in Children With ADHD1,2
NICE guidance recommends that melatonin may be prescribed for children and adolescents aged 6-17 years with ADHD who have insomnia, where sleep hygiene measures have been insufficient.1,2
ADAFLEX can be taken by children taking methylphenidate.2 For patients who experience insomnia as a result of methylphenidate use,7 dose adjustment or switching to another product should be considered.2
ADAFLEX Provides the Reassurance of a Licensed Product
ADAFLEX Provides the Reassurance of a Licensed Product
Around 50% of prescriptions for melatonin are for patients under 18, however prior to the launch of ADAFLEX, prescribing melatonin to those with ADHD and insomnia had been off-label.3 This created challenges with the interface between primary and secondary care as recent research suggests many GPs are reticent to prescribe off-label/unlicensed melatonin.4 As a result, the burden of melatonin prescribing responsibility potentially remained in secondary care, which may be impacting on diagnostic assessment wait times for patients that can be up between 2-3 years in some parts of the UK.5
With ADAFLEX, while use is often initiated by specialists, ongoing maintenance could be continued by GPs – depending on local guidance. Giving the confidence to prescribe a licensed treatment that is in line with NICE guidance on managing insomnia in children and adolescents aged 6-17 years1,2, with ADHD.
ADAFLEX Provides the Reassurance of a Pharmaceutical Quality Product
ADAFLEX Provides the Reassurance of a Pharmaceutical Quality Product
ADAFLEX is a pharmaceutical grade, quality-controlled melatonin that helps avoid any issues patients may encounter with non-prescribed over-the-counter products.
If it’s licensed it’s going to be useful for uptake for families
– UK psychiatrist6
It has a licence…it validates what we are doing
– UK GP6
Administration and Dosing
ADAFLEX Is Uniquely Available in 1-5mg for Effective Titration & Ease of Administration
Helping Healthcare Professionals to ACHIEVE OPTIMUM MELATONIN DOSING
- The ONLY melatonin available in a range of tablet strengths from 1-5mg for children and adolescents aged 6–17 years with insomnia due to ADHD, where sleep hygiene measures have been insufficient.1-5
- The aim of treatment is to establish a healthy sleep pattern with the lowest effective melatonin dose.1 The range of strengths allows you to prescribe a dose that is individualised to your patient.1-5
- The ONLY melatonin available in a 1mg tablet for the treatment of insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient1 – allowing consistency with NICE guidance, which recommends a starting melatonin dose of 1–2mg.6
- NO need to break tablets to achieve correct dosing.
- For those with swallowing difficulties ADAFLEX can be easily crushed and mixed with water.1
- The ONLY melatonin available in a range of tablet strengths from 1-5mg for children and adolescents aged 6–17 years with insomnia due to ADHD, where sleep hygiene measures have been insufficient.1-5
- The aim of treatment is to establish a healthy sleep pattern with the lowest effective melatonin dose.1 The range of strengths allows you to prescribe a dose that is individualised to your patient.1-5
- The ONLY melatonin available in a 1mg tablet for the treatment of insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient1 – allowing consistency with NICE guidance, which recommends a starting melatonin dose of 1–2mg.6
- NO need to break tablets to achieve correct dosing.
- For those with swallowing difficulties ADAFLEX can be easily crushed and mixed with water.1
Are patients taking unlicensed melatonin?
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Advising Patients on ADAFLEX Use
Advise patients to take ADAFLEX 30-60 minutes before bedtime.1
Melatonin has been shown to advance the dim light melatonin onset (DLMO) in children.8
Advise parents/ children to set a desired ‘end-goal’ bedtime, regardless of the actual bedtime, with melatonin taken every night 30–60 minutes before this desired bedtime.1 Melatonin’s ability to improve sleep onset8 should be monitored.
No – there is no need to crush ADAFLEX tablets for immediate release of melatonin.1
As an uncoated tablet, ADAFLEX can be easily crushed and mixed directly with water to make it easy for patients who struggle to swallow tablets.1
This could be an alternative to oral melatonin solutions, which may be more expensive.
Yes – Advise patients to avoid food 2 hours before and after ADAFLEX dose as food can enhance the increase in plasma concentration of melatonin. In addition, intake of melatonin with carbohydrate-rich meals may impair blood glucose control for several hours.1
Initiating Treatment Guidance
Establishing the Optimum ADAFLEX Dose
The Optimal Melatonin Dose
Individual melatonin profiles differ, and therefore optimal dosing may vary among individuals.1 It is recommended that dosing of melatonin supplementation be individually adjusted to account for this variability.2,3 Melatonin treatment should be initiated by physicians experienced in the management of ADHD and/or paediatric sleep medicine.
Patients’ Sleep Symptoms and Melatonin Formulation
Immediate-release (IR) melatonin preparations significantly reduce sleep onset latency and increase total sleep time in patients with ADHD and insomnia4 by advancing the sleep phase and inducing sleep.5 IR formulations are most effective where there are symptoms of delayed sleep onset.6
Individual melatonin profiles differ, and therefore optimal dosing may vary among individuals.1 It is recommended that dosing of melatonin supplementation be individually adjusted to account for this variability.2,3 Melatonin treatment should be initiated by physicians experienced in the management of ADHD and/or paediatric sleep medicine.
Immediate-release (IR) melatonin preparations significantly reduce sleep onset latency and increase total sleep time in patients with ADHD4 by advancing the sleep phase and inducing sleep.5 IR formulations are most effective where there are symptoms of delayed sleep onset.6
Prescribe and Use ADAFLEX in Three Steps
1
Establish the Optimum Dose
- Start with the lowest possible dose.2 The recommended starting dose is 1–2mg, 30-60 minutes prior to the desired bedtime for one week.2
- As an uncoated tablet, ADAFLEX tablets can be easily crushed and mixed with water directly before administration for patients who find tablets difficult to swallow.2 It is recommended that food is not consumed 2 hours before and 2 hours after intake of ADAFLEX.2
- Sleep hygiene measures should be continued throughout treatment.
- Assess patient response and continue treatment if there is clear evidence of benefit.
- If after one week no change occurs, increase the dose by 1 mg weekly until an effect occurs, up to 5mg/day.2 The lowest effective dose should be sought.2
- After at least 3 months’ treatment, the physician should evaluate treatment effect and consider stopping treatment if no clinically relevant effect is seen.
2
Review
Patients should be monitored at regular intervals (at least every 6 months) to check that ADAFLEX is still the most appropriate treatment.2
3
Treatment Review and Discontinuation
During ongoing treatment, especially if the treatment effect is uncertain, discontinuation should be attempted periodically, for example once a year, to assess continued need and whether dosing continues to be the lowest effective dose2. To try to minimise the impact on daily life, consider timing the treatment break when it is convenient for the patient and/or carer, for example in line with school holidays. The duration of this melatonin-free break is at the prescriber’s discretion but could range from 1-4 weeks.
Patients can stop without the need for titration as the plasma elimination half-life is ~ 45 minutes in healthy adults. The half-life, on average, is comparable or slightly shorter in children compared to adults. Dosage once daily in combination with the short half-life means minimal accumulation of melatonin during regular treatment.2 During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should be done regularly, e.g. once per year.2 The use of ADAFLEX is not known to cause any withdrawal effects after treatment completion.7
When the patient has stopped melatonin, assess the impact of this change:
- Sleep patterns maintained: Consider stopping permanently
- Sleep impacted with a detrimental effect on daytime functioning: Restart melatonin treatment.
It is recommended that on re-initiation of melatonin, patients cycle through dose optimisation steps again as dose requirements may have changed, i.e. restart at Step 1.
Patients can stop without the need for titration as the plasma elimination half-life is ~ 45 minutes in healthy adults. The half-life, on average, is comparable or slightly shorter in children compared to adults. Dosage once daily in combination with the short half-life means minimal accumulation of melatonin during regular treatment.2 During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should be done regularly, e.g. once per year.2 The use of ADAFLEX is not known to cause any withdrawal effects after treatment completion.7
When patient has stopped melatonin, assess the impact of this change:
- Sleep patterns maintained: Consider stopping permanently
- Sleep impacted with a detrimental effect on daytime functioning: Restart melatonin treatment.
It is recommended that on re-initiation of melatonin, patients cycle through dose optimisation steps again as dose requirements may have changed, i.e. restart at Step 1.
Changing from Off-Label Melatonin Use
Dosing Considerations for Patients Taking Off-Label Melatonin
An unlicensed product should not be used where a product available and licensed within the UK could be used to meet the patient's special need.1
When changing a patient from one oral formulation to another, for example, switching from an off-label to a licensed treatment, dose adjustment and/or formulation change and additional monitoring may be required. There may also be other issues relating to the suitability of the formulation for the patient, for example administration differences, licence variations, excipients, and bioavailability.
While there is no definitive guidance on changing from one melatonin formulation to another, we have provided some suggestions below.
Regulatory advice is that off-label medicines should only be prescribed to meet the special needs of an individual patient where an equivalent licensed medicine would not meet and better serve the patient’s need.1
When changing a patient from one oral formulation to another, for example, switching from an off-label to a licensed treatment, dose adjustment and/or formulation change and additional monitoring may be required. There may also be other issues relating to the suitability of the formulation for the patient, for example administration differences, licence variations, excipients, and bioavailability.
There is no definitive guidance on changing from one melatonin formulation to another, either immediate-release or modified-release.
Changing Between Melatonin Preparations
Immediate-Release (IR)
Melatonin Tablets
Immediate-Release (IR)
If the optimal dose has been found using an alternative IR tablet, it may be appropriate to initiate ADAFLEX at the same dose as pharmacokinetic properties should be similar. However, considerations should be made to formulation differences which may affect bioavailability, e.g., capsules or liquid preparations. If uncertain, initiate ADAFLEX at 1-2mg and titrate up as appropriate.
Modified-Release (MR)
Melatonin Tablets
Modified-Release (MR)
MR melatonin and IR melatonin have different pharmacokinetic profiles (see figure below)
and as a result, dosing for patients may differ between treatments1.
If a patient is currently on a melatonin treatment (IR or MR), a treatment break could be considered to assess the continued need for melatonin. In patients with insomnia aged 6-17 with ADHD, where ADAFLEX immediate-release, licensed melatonin is clinically appropriate, ADAFLEX should be initiated in line with Steps 1-2 above to ensure optimal dosing2.
Pharmacokinetic profile of modified-release melatonin compared to immediate-release melatonin 2 mg formulations
Figure adapted from Zisapel, 2010.1
UK-AGB-ADA-0023 | Date of preparation: Dec 23
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