SynthesisPaediatric drugs2017
Safety, Tolerability and Efficacy of Drugs for Treating Behavioural Insomnia in Children with Attention-Deficit/Hyperactivity Disorder: A Systematic Review with Methodological Quality Assessment.
Synthesis in Paediatric drugs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05978271 (An Observational Study Investigating the Experience of Patients Undergoing Active Insomnia Clinical Trials), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Observational Study Investigating the Experience of Patients Undergoing Active Insomnia Clinical Trials
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.
- Sleep dysregulation in ADHD children: a systematic review and meta-analysis.Psychological medicine · 2025Pooled it
- The Impact of Transcranial Magnetic Stimulation on Symptoms of Attention Deficit Hyperactivity Disorder and Sleep Parameters: Preliminary Study.Bioengineering (Basel, Switzerland) · 2026Article
- ADHD and Methylphenidate Use in Prepubertal Children and BMI and Height at Adulthood.JAMA network open · 2026Article
- Sleep disturbances in children and adolescents with attention-deficit/hyperactivity disorder: A narrative review.World journal of clinical pediatrics · 2025Review
- Article
- A systematic meta-review of systematic reviews on attention deficit hyperactivity disorder.European psychiatry : the journal of the Association of European Psychiatrists · 2023Review
- Management of sleep disorders among children and adolescents with neurodevelopmental disorders: A practical guide for clinicians.World journal of clinical pediatrics · 2022Review
- Efficacy and safety of supplemental melatonin for delayed sleep-wake phase disorder in children: an overview.Sleep medicine: X · 2020Review
- Auricular Plaster Therapy for Comorbid Insomnia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Evidence-based complementary and alternative medicine : eCAM · 2019Review
- Effects of melatonin in children with attention-deficit/hyperactivity disorder with sleep disorders after methylphenidate treatment.Neuropsychiatric disease and treatment · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveA large proportion of paediatric patients with attention-deficit/hyperactivity disorder (ADHD) have associated sleep problems which not only affect the child's wellbeing but also impact family functioning. Management of sleep problems is consequently an important aspect of overall ADHD management in paediatric patients. Although some drugs are being used off-label for the management of paediatric insomnia, there is scant clinical evidence supporting their use. Our aim was to identify and assess the quality of published studies reporting the safety, tolerability and efficacy of drugs used for treating behavioural insomnia in children with ADHD.
methodsAfter an initial screen to determine which drugs were most commonly used, we conducted a systematic review of English-language publications from searches of PubMed, EMBASE, PsycINFO and two trial register databases to February 2017, using keywords 'clonidine', 'melatonin', 'zolpidem', 'eszopiclone', 'L-theanine', 'guanfacine', 'ADHD', 'sleep disorder' and 'children'. For quality assessment of included studies, we used the CONSORT checklist for randomised control trials (RCTs) and the Downs and Black checklist for non-RCTs.
resultsTwelve studies were included. Two case series for clonidine, two RCTs and four observational studies for melatonin and one RCT each for zolpidem, eszopiclone, L-theanine and guanfacine. Of the 12 included studies, only one on eszopiclone scored excellent for quality. The quality of the rest of the studies varied from moderate to low. For clonidine, melatonin and L-theanine, improvements in sleep-onset latency and total sleep duration were reported; however, zolpidem, eszopiclone and guanfacine failed to show any improvement when compared with placebo. Clonidine, melatonin, L-theanine, eszopiclone and guanfacine were well tolerated with mild to moderate adverse events; zolpidem was associated with neuropsychiatric adverse effects.
conclusionThere is generally poor evidence for prescribing drugs for behavioural insomnia in children with ADHD. Further controlled studies are warranted.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.