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Modafinil/armodafinil in obstructive sleep apnoea: a systematic review and meta-analysis

Julia L. Chapman, Andrew Vakulin, Jan Hedner, Brendon J. Yee, Nathaniel S. Marshall
European Respiratory Journal 2016 47: 1420-1428; DOI: 10.1183/13993003.01509-2015
Julia L. Chapman
1The NHMRC Centres of Research Excellence, CIRUS and NEUROSLEEP, Woolcock Institute of Medical Research, The University of Sydney, Sydney, Australia
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  • For correspondence: julia.chapman@sydney.edu.au
Andrew Vakulin
1The NHMRC Centres of Research Excellence, CIRUS and NEUROSLEEP, Woolcock Institute of Medical Research, The University of Sydney, Sydney, Australia
2Adelaide Institute for Sleep Health, A Flinders Centre of Research Excellence, School of Medicine, Faculty of Medicine, Nursing and Health Sciences, Flinders University, Adelaide, Australia
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Jan Hedner
3Centre for Sleep and Vigilance Disorders, Dept of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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Brendon J. Yee
1The NHMRC Centres of Research Excellence, CIRUS and NEUROSLEEP, Woolcock Institute of Medical Research, The University of Sydney, Sydney, Australia
4Dept of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Sydney, Australia
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Nathaniel S. Marshall
1The NHMRC Centres of Research Excellence, CIRUS and NEUROSLEEP, Woolcock Institute of Medical Research, The University of Sydney, Sydney, Australia
5Sydney Nursing School, The University of Sydney, Sydney, Australia
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Abstract

Modafinil is used internationally to treat residual sleepiness despite continuous positive airway pressure in obstructive sleep apnoea (res-OSA). In 2011, the European Medicines Agency removed the indication based on an unfavourable risk–benefit profile in two trials for efficacy and all accumulated safety data. We performed a meta-analysis of all randomised controlled trials of modafinil (or armodafinil) in res-OSA to quantify efficacy and safety.

We systematically searched and assessed studies from major databases, conferences and trials registries to find randomised, placebo-controlled trials of modafinil/armodafinil for ≥2 weeks in adult res-OSA treating sleepiness.

We analysed 10 of the 232 articles identified that met inclusion criteria (1466 patients). Modafinil/armodafinil improved the Epworth Sleepiness Scale score (2.2 points, 95% CI 1.5–2.9) and the Maintenance of Wakefulness Test over placebo (3 min, 95% CI 2.1–3.8 min). Modafinil/armodafinil tripled adverse events and doubled adverse events leading to withdrawal but did not increase serious adverse events (hospitalisations or death).

Modafinil and armodafinil improve subjective and objective daytime sleepiness in res-OSA. We believe our analysis is a fairer analysis of the risk–benefit profile of this indication. Clinicians may want to use this data to balance the risks and benefits on a case-by-case basis with their patients.

Abstract

An EMA risk–benefit analysis of modafinil in OSA was negative. Does analysing extra trials change the conclusion? http://ow.ly/VYvO8

Footnotes

  • This article has supplementary material available from erj.ersjournals.com

  • Support statement: This research was supported by an Australian National Health and Medical Research Council (NHMRC) grant to N.S. Marshall (1004528) and a University of Sydney Bridging Grant to N.S. Marshall. J.L. Chapman is supported by a NHMRC postgraduate scholarship (1038709). Funding information for this article has been deposited with FundRef.

  • Conflict of Interest: Disclosures can be found alongside the online version of this article at erj.ersjournals.com

  • Received September 10, 2015.
  • Accepted November 27, 2015.
  • Copyright ©ERS 2016
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Modafinil/armodafinil in obstructive sleep apnoea: a systematic review and meta-analysis
Julia L. Chapman, Andrew Vakulin, Jan Hedner, Brendon J. Yee, Nathaniel S. Marshall
European Respiratory Journal May 2016, 47 (5) 1420-1428; DOI: 10.1183/13993003.01509-2015

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Modafinil/armodafinil in obstructive sleep apnoea: a systematic review and meta-analysis
Julia L. Chapman, Andrew Vakulin, Jan Hedner, Brendon J. Yee, Nathaniel S. Marshall
European Respiratory Journal May 2016, 47 (5) 1420-1428; DOI: 10.1183/13993003.01509-2015
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