Research Reports - Armodafinil for the treatment of excessive sleepiness associated with traumatic brain injury

J Clin Sleep Med. 2014 Nov 15;10(11):1181-91

Menn SJ(1), Yang R(2), Lankford A(3)

OBJECTIVE: To evaluate the efficacy and tolerability of armodafinil in patients
with excessive sleepiness following mild or moderate closed traumatic brain
injury (TBI).
DESIGN: Randomized, placebo-controlled, double-blind trial followed by open-label
extension.
SETTING: 40 US centers.
PATIENTS: Adults with closed TBI (N = 117), Glasgow Coma Scale score >8 at time
of injury; baseline Epworth Sleepiness Scale (ESS) ≥10; sleep latency <8 minutes
on multiple sleep latency test (MSLT); and Clinical Global Impression-Severity of
Illness (CGI-S) score ≥4 for excessive sleepiness.
INTERVENTION: Patients received armodafinil (50, 150, or 250 mg/day) or placebo
for 12 weeks followed by an optional 12-month open-label extension.
MEASUREMENTS AND RESULTS: Outcomes included MSLT, ESS, Clinical Global
Impression-Change (CGI-C), TBI-Work Instability Scale (TBI-WIS), CGI-S, and
tolerability. The study was terminated early due to low enrollment. Patients
receiving 250 mg armodafinil showed significant improvement in sleep latency from
baseline to final visit versus placebo (+7.2 minutes vs. +2.4 minutes; p =
0.0010). CGI-C ratings were much/ very much improved in approximately 50% of
patients receiving 150 and 250 mg armodafinil, compared to 38% on placebo. ESS
and TBI-WIS scores were not significantly different between groups. In the
open-label extension (N = 49), patients demonstrated gradual improvement in ESS,
TBI-WIS, and CGI-S scores up to 48 weeks post-baseline. Armodafinil was generally
well tolerated, with headache the most common adverse event in both double-blind
and open-label portions.
CONCLUSIONS: Armodafinil 250 mg significantly improved sleep latency in patients
with excessive sleepiness associated with mild or moderate TBI. Efficacy and
tolerability of armodafinil were sustained throughout the open-label extension.

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