A double-blind, placebo-controlled investigation of the efficacy of modafinil for sustaining the alertness and performance of aviators: a helicopter simulator study.

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.

Efficacy of Dexedrine for maintaining aviator performance during 64 hours of sustained wakefulness: a simulator study.

INTRODUCTION: The efficacy of Dexedrine for sustaining aviator performance despite 64 h of extended wakefulness was investigated. This study was conducted to extend the findings of earlier research that had proven the efficacy of Dexedrine during shorter periods (i.e., 40 h) of sleep deprivation. METHODS: Dexedrine (10 mg) or placebo was given at midnight, 0400, and 0800 hours on two deprivation days in each of two 64-h cycles of continuous wakefulness. Test sessions consisting of simulator flights, electroencephalographic evaluations, mood questionnaires, and cognitive tasks were conducted at 0100, 0500, 0900, 1300, and 1700 hours on both deprivation days. Two nights of recovery sleep separated the first and second 64-h sleep-deprivation cycles. RESULTS: Simulator flight performance was maintained by Dexedrine throughout sleep deprivation. The most benefit occurred at 0500 and 0900 hours (around the circadian trough) on the first deprivation day, but continued throughout 1700 hours (after 58 h awake) on the second day. Dexedrine suppressed slow-wave EEG activity which occurred under placebo after 23 h awake and continued to exert this effect throughout 55 h (and sometimes 59 h) of deprivation. The drug sustained self-perceptions of vigor while reducing fatigue and confusion. Recovery sleep was slightly less restful under Dexedrine. CONCLUSIONS: Dexedrine sustained aviator performance and alertness during periods of extended wakefulness, but its use should be well controlled. Although effective, Dexedrine is no replacement for adequate crew rest management or restful sleep.