The impact of shift duration on the efficacy and tolerability of armodafinil in patients with excessive sleepiness associated with shift work disorder

Abstract

Objective:

To examine the impact of night-shift duration (≤9 hours or >9 hours) on efficacy and tolerability of armodafinil in patients with shift work disorder (SWD).

Methods:

This was a post hoc analysis of a 6 week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Shift workers with diagnosed SWD and late-in-shift sleepiness (between 4 am and 8 am, including the commute home) received armodafinil 150 mg or placebo before their night shift.

Results:

Proportion of patients with at least minimal improvement in late-in-shift sleepiness, late-in-shift Clinical Global Impressions–Change (CGI-C) rating and Karolinska Sleepiness Scale (KSS), as well as overall Global Assessment of Functioning (GAF) scale and modified Sheehan Disability Scale (SDS-M), were assessed at baseline and final visit.

Results:

Of the 383 patients enrolled, 279 (73%) worked shifts ≤9 hours and 104 (27%) worked shifts >9 hours. A greater percentage of patients receiving armodafinil had at least minimal improvement in late-in-shift CGI-C (≤9 hours: 78% vs 60%, P = 0.0017; >9 hours: 77% vs 46%, P = 0.0020) regardless of shift duration. Armodafinil patients also demonstrated significantly greater improvements in GAF score (≤9 hours: 9.5 vs 5.4, P < 0.0001; >9 hours: 9.6 vs 4.3, P = 0.0019) and KSS score (≤9 hours: −2.9 vs −1.9, P = 0.0002; >9 hours: −2.8 vs −1.6, P = 0.00 28). Improvement in SDS-M composite score was significantly greater for armodafinil patients working >9 hours (−6.8 vs −2.7, P = 0.0086). Headache was the most frequent adverse event in all treatment groups.

Conclusions:

Patients receiving armodafinil had significantly greater improvements in late-in-shift clinical condition and in wakefulness and overall global functioning than did placebo-treated patients, regardless of shift duration. Prospectively designed, randomized clinical trials that include objective measures of sleepiness are needed to support these findings.

Keywords::

• Armodafinil
• Shift duration
• Shift work disorder
• Sleep disorder

Transparency

Declaration of funding

This study was sponsored by Cephalon Inc. (now doing business as Teva Pharmaceuticals), a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd (Petah Tikva, Israel). Funding for the preparation of this manuscript was provided by Teva Pharmaceuticals.

Declaration of financial/other relationships

R.Y. has disclosed that he is an employee of Teva Pharmaceuticals. J.H. and S.G.H. have disclosed that they received sponsorship from Teva for their role in developing this study.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors thank Joyce Willets PhD and Sarah Mizne PharmD of MedVal Scientific Information Services LLC for providing medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals’ ‘Good Publication Practice for Communicating Company-Sponsored Medical Research: The GPP2 Guidelines’.

Previous presentations: American Psychiatric Association 165th Annual Meeting, Philadelphia, PA, USA, 5–9 May 2012; Associated Professional Sleep Societies SLEEP 2012 Meeting, Boston, MA, USA, 9–13 June 2012.