A double-blind, placebo-controlled investigation of the
efficacy of modafinil for sustaining the alertness and performance of aviators:
a helicopter simulator study.
Caldwell JA, Caldwell JL, Smythe NK, Hall KK
Aeromedical Research Laboratory,
Fort Rucker, AL 36362-0577, USA John.Caldwell@se.amedd.army.mil
Psychopharmacology (Berl) 2000 Jun;150(3):272-82
ABSTRACT
RATIONALE: In 1998, the FDA approved modafinil for
treating excessive daytime sleepiness in narcoleptics, and this has raised
questions about the appropriateness of this compound for enhancing alertness in
sleep-deprived controls. This study explored the efficacy of modafinil for
maintaining the performance of volunteers required to accomplish highly
demanding tasks despite sleep loss.
OBJECTIVE: The principal objective was to determine whether prophylactic doses
of modafinil would attenuate decrements in aviator performance and arousal
throughout 2 days and 1 night without sleep.
METHODS: Six pilots were exposed to two 40-h periods of continuous wakefulness.
In one, three 200-mg doses of modafinil were given and in the other, matching
placebos were administered. Helicopter simulator flights, resting EEGs, and
Profile of Mood States (POMS) questionnaires were evaluated.
RESULTS: Modafinil attenuated sleep deprivation effects on four of six flight
maneuvers, reduced slow-wave EEG activity, and lessened self-reported problems
with mood and alertness in comparison to placebo. The most noticeable benefits
occurred between 0330 and 1130 hours, when the combined impact of sleep loss and
the circadian trough was most severe. The most frequently observed drug side
effects were vertigo, nausea, and dizziness. These could have been related to:
1) the motion-based testing, 2) the use of a simulator rather than an actual
aircraft (i.e., "simulator sickness"), and/or 3) the administration of more than
400 mg modafinil.
CONCLUSIONS: Modafinil is a promising countermeasure for sleep loss in normals;
however, additional studies aimed at reducing side effects are needed before it
should be used in aviators.
