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Safety, tolerability and efficacy of drugs for treating behavioural insomnia in children with attention-deficit/hyperactivity disorder: a systematic review with methodological quality assessment

Safety, tolerability and efficacy of drugs for treating behavioural insomnia in children with attention-deficit/hyperactivity disorder: a systematic review with methodological quality assessment
Safety, tolerability and efficacy of drugs for treating behavioural insomnia in children with attention-deficit/hyperactivity disorder: a systematic review with methodological quality assessment
OBJECTIVE:

A 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.

METHODS:

After 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.

RESULTS:

Twelve 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.

CONCLUSION:

There is generally poor evidence for prescribing drugs for behavioural insomnia in children with ADHD. Further controlled studies are warranted.
1174-5878
235-250
Anand, Shweta
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Tong, Henry
bd7b8d82-5811-491a-a83d-cfc0547997c6
Besag, Frank M.C.
511d3cd8-e69b-4a6e-b5a3-6909a3f5cdb6
Chan, Esther W.
bc0ff55d-fb33-491c-8185-79f577e925d1
Cortese, Samuele
53d4bf2c-4e0e-4c77-9385-218350560fdb
Wong, Ian C.K.
840ce8fe-8964-48d1-9708-01609165d6a1
Anand, Shweta, Tong, Henry, Besag, Frank M.C., Chan, Esther W., Cortese, Samuele and Wong, Ian C.K. (2017) Safety, tolerability and efficacy of drugs for treating behavioural insomnia in children with attention-deficit/hyperactivity disorder: a systematic review with methodological quality assessment Paediatric Drugs, 19, (3), pp. 235-250. (doi:10.1007/s40272-017-0224-6).

Anand, Shweta, Tong, Henry, Besag, Frank M.C., Chan, Esther W., Cortese, Samuele and Wong, Ian C.K. (2017) Safety, tolerability and efficacy of drugs for treating behavioural insomnia in children with attention-deficit/hyperactivity disorder: a systematic review with methodological quality assessment Paediatric Drugs, 19, (3), pp. 235-250. (doi:10.1007/s40272-017-0224-6).

Record type: Article

Abstract

OBJECTIVE:

A 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.

METHODS:

After 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.

RESULTS:

Twelve 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.

CONCLUSION:

There is generally poor evidence for prescribing drugs for behavioural insomnia in children with ADHD. Further controlled studies are warranted.

Other Anand - Accepted Manuscript
Restricted to Repository staff only until 8 April 2018.

More information

Accepted/In Press date: 8 April 2017
e-pub ahead of print date: 8 April 2017
Published date: June 2017

Identifiers

Local EPrints ID: 412343
URI: http://eprints.soton.ac.uk/id/eprint/412343
ISSN: 1174-5878
PURE UUID: ed9727c3-67f4-4ef5-a6c9-548b51ecbbe3
ORCID for Samuele Cortese: ORCID iD orcid.org/0000-0001-5877-8075

Catalogue record

Date deposited: 17 Jul 2017 13:30
Last modified: 17 Jul 2017 13:30

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Contributors

Author: Shweta Anand
Author: Henry Tong
Author: Frank M.C. Besag
Author: Esther W. Chan
Author: Samuele Cortese ORCID iD
Author: Ian C.K. Wong

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