Clinical Overview
Immediate Release (IR) Melatonin Is Clinically Proven to Improve Sleep in Children Aged 6–17 Years With ADHD-Related Insomnia, Where Sleep Hygiene Measures Have Been Insufficient1-5
ADAFLEX contains melatonin, which is clinically proven in a number of studies to improve sleep in children with ADHD and insomnia.1-5 Meta-analyses and systematic reviews also confirm the sleep-enhancing benefits of melatonin in this patient population.6,7
ADAFLEX’s immediate release (IR) formulation1 makes it particularly suitable for patients experiencing sleep onset difficulty – seen in 87% of children with ADHD-related sleep problems.8
Clinically Proven to Reduce Sleep Onset Latency1
IR Melatonin: Reduces Time to Sleep Onset in ADHD Children With Insomnia, Aged 6–12 Years, Where Sleep Hygiene Measures Have Been Insufficient
Van der Heijden, 20071
Randomised, double-blind, placebo controlled study in 105 medication-free children aged 6-12 years with ADHD and chronic sleep onset insomnia given either melatonin or placebo for 4 weeks.1
- Sleep onset advanced by 26.9 ± 47.8 minutes with melatonin and was delayed by 10.5 ± 37.4 minutes with placebo (p < .0001).1
- 49% of children showed an advance of sleep onset of >30 minutes with melatonin vs 13% taking placebo at 4 weeks (p=0.001).1
- In addition, melatonin vs placebo, at 4 weeks1:
- Reduced difficulty falling asleep (p<0.0001)
- Improved sleep efficiency (p=0.011).
Parental Experience with ADAFLEX2
In a survey, 91% of parents were highly satisfied/satisfied with ADAFLEX's impact on their child’s sleep onset issues.2‡
‡Based on an online survey of parents of users of ADAFLEX and other immediate release melatonin products (n=152).2
IR Melatonin: Reduces Time to Sleep Onset in ADHD Children With Insomnia, Aged 6–12 Years, Where Sleep Hygiene Measures Have Been Insufficient
Van der Heijden, 20071
Randomised, double-blind, placebo controlled study in 105 medication-free children aged 6-12 years with ADHD and chronic sleep onset insomnia given either melatonin or placebo for 4 weeks.1*
- Melatonin advanced sleep onset by 26.9 ± 47.8 minutes with melatonin and delayed sleep onset by 10.5 ± 37.4 minutes with placebo (p < .0001). 1
- 49% of children showed an advance of sleep onset of >30 minutes with melatonin vs 13% taking placebo at 4 weeks (p=0.001).1
- In addition, melatonin vs placebo, at 4 weeks1:
- Reduced difficulty falling asleep (p<0.001)
- Improved sleep efficiency (p=0.011).
Parental experience with ADAFLEX2
In a survey, 94% of parents were highly satisfied/satisfied with ADAFLEX’s impact on their child’s sleep onset issues.2‡
‡Based on an online survey of parents of users of ADAFLEX and other immediate release melatonin products (n=270).9
Mean difficulty in falling asleep as reported by parents, averaged over 7 days on a scale of 1 (not difficult) to 5 (very difficult).
Figure adapted from Van der Heijden, et al, 2007.1
IR Melatonin: Reduces Time to Sleep Onset in ADHD Children With Insomnia, Aged 6–14 Years, Where Sleep Hygiene Measures Have Been Insufficient
Weiss, 20063
Randomised, double-blind, placebo-controlled, 30-day crossover study in 33 ADHD children with initial insomnia aged 6-14 years, who did not respond to sleep hygiene measures.3*
- Melatonin time to sleep onset was 46.4 minutes vs 62.1 minutes for placebo on the mean somnolog measure at 30 days (p<0.01).3
- Melatonin was superior to placebo on actigraph measurement of sleep onset latency by 16 minutes at 30 days (p<0.01)3
- In addition, melatonin vs placebo, at 30 days3
- Improved total sleep time vs placebo by 15 minutes (p<0.01)
- During the open-label phase of the study (additional 90 days), sleep duration with melatonin improved by a further 23 minutes (p<0.01).
*Subjects (children aged 6-14 years) randomly assigned to receive either melatonin 5mg or placebo or the reverse3
IR Melatonin: Reduces Time to Sleep Onset in ADHD Children With Insomnia, Aged 6–14 Years, Where Sleep Hygiene Measures Have Been Insufficient
Weiss, 20063
Randomised, double-blind, placebo-controlled, 30-day crossover study in 33 ADHD children with initial insomnia aged 6-14 years, who did not respond to sleep hygiene measures.3*
- Melatonin time to sleep onset was 46.4 minutes vs 62.1 minutes for placebo on the mean somnolog measure at 30 days (p<0.01).3
- Melatonin was superior to placebo on actigraph measurement of sleep onset latency by 16 minutes at 30 days (p<0.01)3
- In addition, melatonin vs placebo, at 30 days3
- Improved total sleep time vs placebo by 15 minutes (p<0.01)
- During the open-label phase of the study (additional 90 days), sleep duration with melatonin improved by a further 23 minutes (p<0.01).
*Subjects (children aged 6-14 years) randomly assigned to receive either melatonin 5mg or placebo or the reverse3
Melatonin was superior to sleep hygiene and placebo in improving sleep onset latency3
Melatonin was superior to sleep hygiene and placebo in improving sleep onset latency3
Figure adapted from Weiss, et al, 2006.3
Almost 9 Out of 10 Parents Surveyed Saw the Benefits in Their Children’s Sleep Onset1*
IR melatonin: parents saw the benefits in their children's ADHD-related insomnia, aged 6–12 years, where sleep hygiene measures have been insufficient
Hoebert, 20091*
Follow-up questionnaire1 of parents of 94 children participating in van der Heijden, 2007 study (a randomised, double-blind, placebo-controlled trial of immediate release melatonin treatment in children aged 6-12 years over 4 weeks).2
- 87.8% of parents felt melatonin was an effective treatment in improving sleep onset in their child.1
- 64.9% of children were still taking melatonin daily at follow-up (mean follow-up time was 3.66 years).1†
- A further 11.7% of children were taking melatonin occasionally to help them sleep.1
Discontinuing Melatonin
- Among children who discontinued melatonin use, 92.3% had a delay in sleep onset time.1
†Melatonin dose at follow up: 0.5-10mg.1
*Based on a follow-up questionnaire of parents of 72 children participating in Van der Heijden, 2007 study (a randomised, double-blind, placebo-controlled trial of melatonin treatment in children aged 6-12 years over 4 weeks).4
IR melatonin: parents saw the benefits in their children's ADHD-related insomnia, aged 6–12 years, where sleep hygiene measures have been insufficient
Hoebert, 20091*
Follow-up questionnaire1 of parents of 72 children participating in van der Heijden, 2007 study (a randomised, double-blind, placebo-controlled trial of immediate release melatonin treatment in children aged 6-12 years over 4 weeks).2
- 87.8% of parents felt melatonin was an effective treatment in improving sleep onset in their child.1
- 64.9% of children were still taking melatonin daily at follow-up (mean follow-up time was 3.66 years).1†
- A further 11.7% of children were taking melatonin occasionally to help them sleep.1*
Discontinuing melatonin
- Among children who discontinued melatonin use, 92.3% had a delay in sleep onset time.1
*Based on a follow-up questionnaire of parents of 72 children participating in Van der Heijden, 2007 study (a randomised, double-blind, placebo-controlled trial of melatonin treatment in children aged 6-12 years over 4 weeks).4
†Melatonin dose at follow up: 0.5-10mg.1
Parental opinion of effect of melatonin on sleep onset insomnia1
Parental opinion of effect of melatonin on sleep onset insomnia1
Figure adapted from Hoebert, et al, 2009.1
Over 90% of Parents/Caregivers Were Satisfied With the Effect of ADAFLEX on Their Child’s Sleep Onset1*
ADAFLEX: Parents Were Highly Satisfied With the Effect of ADAFLEX on Their Child's Insomnia.
Based on an online survey of parents of users of ADAFLEX and other IR melatonin products (n=152).
AGB-Pharma Parent/Caregiver Survey1*
In a survey of parents/caregivers of children taking immediate release melatonin, ADAFLEX was found to offer high levels of satisfaction with its impact on children’s sleep:
- 91% were highly satisfied/satisfied with ADAFLEX’s impact on sleep onset insomnia
-
Parents reported on average a 70% improvement in sleep onset issues in their children.
*Based on an online survey of parents of users of ADAFLEX and other immediate release melatonin products (n=152).
Parental opinion of effect of ADAFLEX on sleep onset insomnia1
Parent/Caregivers Reported Benefits as a result of improved sleep:1*
- Parents/caregivers reported less psychological strain due to their child’s sleeping issues with Adaflex use – dropping from 72% before treatment to 9% after treatment.
- Parents/caregivers reported a reduced impact of their child’s sleep after Adaflex treatment on:
- Education (from 51% reporting an impact pre-treatment to 17% after treatment)
- Mental health (from 51% to 11%)
- Family life (46% to 10%)
- Social life (26% to 9%)
- Sporting activities (20% to 3%).
Clinically Proven to Increase Total Sleep Time1
IR Melatonin: Increased Sleep Time in ADHD Children With Insomnia, Aged 6–12 Years, Where Sleep Hygiene Measures Have Been Insufficient
Van der Heijden, 20071
Randomised, double-blind, placebo controlled study in 105 medication-free children aged 6-12 years with ADHD and chronic sleep onset insomnia given either melatonin or placebo for 4 weeks.1*
- Melatonin increased total time asleep by up to 80 minutes: Total time asleep increased with melatonin (+19.8 ± 61.9 minutes)
as compared to placebo (-13.6 ± 50.6 minutes; p = .01).1
IR Melatonin: Increased Sleep Time in ADHD Children With Insomnia, Aged 6–12 Years, Where Sleep Hygiene Measures Have Been Insufficient
Van der Heijden, 20071
Randomised, double-blind, placebo controlled study in 105 medication-free children aged 6-12 years with ADHD and chronic sleep onset insomnia given either melatonin or placebo for 4 weeks.1*
- Melatonin increased total time asleep by up to 80 minutes; Total time asleep increased with melatonin (+19.8 ± 61.9 minutes)
as compared to placebo (-13.6 ± 50.6 minutes; p = .01).1
Melatonin increased total sleep time at 4 weeks (p=0.01)1
Figure adapted from Van der Heijden, et al, 2007.1
Melatonin Is Well-Tolerated1-5
Short-Term Data
Extensive research has shown that melatonin is well tolerated in the short-term.1,2,4,5
A low frequency of, in general, mild adverse reactions have been reported in the paediatric population.4 The number of adverse reactions has not differed significantly between children who have received placebo compared to melatonin.4 The most common adverse reactions were headache, hyperactivity, dizziness and abdominal pain.4
Long-Term Data
While there are limited data on long-term effects,4 several studies and literature reviews have confirmed the long-term acceptability of melatonin in a range of patient types, including children, used over a period of 1-10.8 years.6-9
A follow-up questionnaire among parents of ADHD children taking melatonin for a mean of 3.66 years noted that long-term use had identified no safety concerns among their children.3
During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should be done regularly, e.g. once per year.4
UK-AGB-ADA-0024 | Date of preparation: Jan 24
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