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Eur Respir J. 2018 Jul 19;52(1). pii: 1800149. doi: 10.1183/13993003.00149-2018. Print 2018 Jul.

Effect of 1 month of zopiclone on obstructive sleep apnoea severity and symptoms: a randomised controlled trial.

Author information

1
Neuroscience Research Australia (NeuRA), Sydney, Australia.
2
The Woolcock Institute of Medical Research, Sydney, Australia.
3
School of Psychology, Faculty of Science, Brain and Mind Centre and Charles Perkins Centre, The University of Sydney, Sydney, Australia.
4
Prince of Wales Hospital, Sydney, Australia.
5
Royal Prince Alfred Hospital and Sydney Local Heath District, Camperdown, Australia.

Abstract

Hypnotic use in obstructive sleep apnoea (OSA) is contraindicated due to safety concerns. Recent studies indicate that single-night hypnotic use worsens hypoxaemia in some and reduces OSA severity in others depending on differences in pathophysiology. However, longer clinical trial data are lacking. This study aimed to determine the effects of 1 month of zopiclone on OSA severity, sleepiness and alertness in patients with low-moderate respiratory arousal thresholds without major overnight hypoxaemia.69 participants completed a physiology screening night with an epiglottic catheter to quantify arousal threshold. 30 eligible patients (apnoea-hypopnoea index (AHI) 22±11 events·h-1) then completed standard in-laboratory polysomnography (baseline) and returned for two additional overnight sleep studies (nights 1 and 30) after receiving either nightly zopiclone (7.5 mg) or placebo during a 1-month, double-blind, randomised, parallel trial (ANZCTR identifier ANZCTRN12613001106729).The change in AHI from baseline to night 30 was not different between zopiclone versus placebo groups (-5.9±10.2 versus -2.4±5.5 events·h-1; p=0.24). Similarly, hypoxaemia, next-day sleepiness and driving simulator performance were not different.1 month of zopiclone does not worsen OSA severity, sleepiness or alertness in selected patients without major overnight hypoxaemia. As the first study to assess the effect of a hypnotic on OSA severity and sleepiness beyond single-night studies, these findings provide important safety data and insight into OSA pathophysiology.

PMID:
29976648
DOI:
10.1183/13993003.00149-2018
[Indexed for MEDLINE]
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Conflict of interest statement

Conflict of interest: S.G. Carter reports grants from the National Health and Medical Research Council (NHMRC; grant 1042493), and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), personal fees (Postgraduate Research Top-up Scholarship) from NeuroSleep, a NHMRC Centre for Research Excellence and personal fees (Supplementary Scholarship) from Neuroscience Research Australia (NeuRA), during the conduct of the study; and personal fees for part-time employment from ResSleep, outside the submitted work. Conflict of interest: J.C. Carberry reports grants from the NHMRC (grant 1042493) and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), during the conduct of the study. Conflict of interest: G. Cho reports grants from the NHMRC (grant 1042493) and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), during the conduct of the study. Conflict of interest: L.P. Fisher reports grants from the NHMRC (grant 1042493) and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), during the conduct of the study. Conflict of interest: C.M. Rollo reports grants from the NHMRC (grant 1042493) and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), during the conduct of the study. Conflict of interest: D.J. Stevens reports grants from the NHMRC (grant 1042493) and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), during the conduct of the study. Conflict of interest: R.R. Grunstein reports grants the NHMRC (grant 1042493) and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), during the conduct of the study, and personal fees for local advisory board activity from Merck and Teva, outside the submitted work. Conflict of interest: D.J. Eckert reports grants from the NHMRC (grant 1042493 and fellowship 1116942) and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), during the conduct of the study, and grants from Commonwealth Government of Australia Cooperative Research Centre Grant (industry partner Oventus Medical) and personal fees for advisory board activities and consultancy from Bayer, outside the submitted work. Conflict of interest: A.L. D'Rozario reports grants from the NHMRC (grant 1042493), and NeuroSleep, a NHMRC Centre for Research Excellence (grant 1060992), during the conduct of the study.

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