A phase 3, double-blind, randomized, placebo-controlled study of armodafinil for excessive sleepiness associated with jet lag disorder.
OBJECTIVE
To assess the effect of armodafinil, the longer-lasting isomer of modafinil, on jet lag disorder.


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%).


CONCLUSIONS
Armodafinil increased wakefulness after eastward travel through 6 time zones.


BACKGROUND
clinicaltrials.gov identifier: NCT00758498.
Rosenberg
Russell P
RP
NeuroTrials Research, Atlanta, GA 30342, USA. russell.rosenberg@atlantasleep.com
Bogan
Richard K
RK
Tiller
Jane M
JM
Yang
Ronghua
R
Youakim
James M
JM
Earl
Craig Q
CQ
Roth
Thomas
T
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001294:Attitude to Health; D001559:Benzhydryl Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D020179:Jet Lag Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D017286:Polysomnography; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects*
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil