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Mayo Clin Proc. 2010 Jul;85(7):630-8. doi: 10.4065/mcp.2009.0778. Epub 2010 Jun 7.

A phase 3, double-blind, randomized, placebo-controlled study of armodafinil for excessive sleepiness associated with jet lag disorder.

Author information

1
NeuroTrials Research, Atlanta, GA 30342, USA. russell.rosenberg@atlantasleep.com

Abstract

OBJECTIVE:

To assess the effect of armodafinil, the longer-lasting isomer of modafinil, on jet lag disorder.

PARTICIPANTS AND METHODS:

This double-blind, randomized, parallel-group, multicenter study was conducted between September 18, 2008, and February 9, 2009. Adults with a history of jet lag symptoms on previous flights through multiple time zones flew from the United States to France (a 6-hour time zone change) for a 3-day laboratory-based study period. Participants received armodafinil (50 or 150 mg/d) or placebo each morning. Wakefulness was assessed by the coprimary outcomes, mean sleep latency on the Multiple Sleep Latency Test (MSLT) (average of all MSLT sessions across days 1 and 2) and Patient Global Impression of Severity in relation to jet lag symptoms (averaged across days 1 and 2).

RESULTS:

A total of 427 participants received armodafinil at 50 mg/d (n=142), armodafinil at 150 mg/d (n=143), or placebo (n=142). Armodafinil at 150 mg/d provided a significant benefit in sleep latency on the MSLT (days 1-2: mean, 11.7 minutes vs 4.8 minutes for placebo; P<.001) and participants' perception of their overall condition in relation to jet lag symptoms (Patient Global Impression of Severity, days 1-2: mean, 1.6 vs 1.9 for placebo; P<.05). The most frequently reported adverse events for armodafinil at 150 mg/d were headache (27%), nausea (13%), diarrhea (5%), circadian rhythm sleep disorder (5%), and palpitations (5%).

CONCLUSION:

Armodafinil increased wakefulness after eastward travel through 6 time zones.

TRIAL REGISTRATION:

clinicaltrials.gov identifier: NCT00758498.

PMID:
20530317
PMCID:
PMC2894718
DOI:
10.4065/mcp.2009.0778
[Indexed for MEDLINE]
Free PMC Article

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