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

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

SUBMITTER: Rosenberg RP 

PROVIDER: S-EPMC2894718 | biostudies-literature | 2010 Jul

REPOSITORIES: biostudies-literature