BACKGROUND:Zaleplon appears to be a prime candidate for assisting individuals in obtaining sleep in situations not conducive to rest (i.e., a short period during the day). However, should an early unexpected awakening and return to duty be required, the effect on performance is not known. HYPOTHESIS: Zaleplon (10 mg) would negatively affect human performance for some duration, compared with placebo, after a sudden awakening from a short period (1 h) of daytime sleep. METHODS: There were 16 participants, 8 men and 8 women, who volunteered to participate in this study. The study was conducted using a counterbalanced, double-blind, repeated measures design. At 1 h prior to drug administration, and at each of 7 h postdrug, performance measures (cognition, memory, balance, and strength) and subjective symptom reports were recorded. RESULTS:Zaleplon had a statistically significant (p < 0.05) negative impact on balance through the first 2 h postdose when compared with placebo. In addition, symptoms related to "drowsiness" were statistically more prevalent under zaleplon than under placebo through the first 3 h postdrug. Of the eight measures of cognitive performance, six were significantly negatively impacted in the zaleplon condition through 2 h postdose when compared with placebo, with one remaining significantly degraded through 3 h postdose. Zaleplon also had a significantly negative impact on memory at 1 h and 4 h postdose. CONCLUSIONS:Zaleplon (10 mg), when used as a daytime sleep aid, causes drowsiness (and related symptoms) up to 3 h postdose, and may impact task performance, especially more complex tasks, for at least 2-3 h postdose.
RCT Entities:
BACKGROUND:Zaleplon appears to be a prime candidate for assisting individuals in obtaining sleep in situations not conducive to rest (i.e., a short period during the day). However, should an early unexpected awakening and return to duty be required, the effect on performance is not known. HYPOTHESIS: Zaleplon (10 mg) would negatively affect human performance for some duration, compared with placebo, after a sudden awakening from a short period (1 h) of daytime sleep. METHODS: There were 16 participants, 8 men and 8 women, who volunteered to participate in this study. The study was conducted using a counterbalanced, double-blind, repeated measures design. At 1 h prior to drug administration, and at each of 7 h postdrug, performance measures (cognition, memory, balance, and strength) and subjective symptom reports were recorded. RESULTS:Zaleplon had a statistically significant (p < 0.05) negative impact on balance through the first 2 h postdose when compared with placebo. In addition, symptoms related to "drowsiness" were statistically more prevalent under zaleplon than under placebo through the first 3 h postdrug. Of the eight measures of cognitive performance, six were significantly negatively impacted in the zaleplon condition through 2 h postdose when compared with placebo, with one remaining significantly degraded through 3 h postdose. Zaleplon also had a significantly negative impact on memory at 1 h and 4 h postdose. CONCLUSIONS:Zaleplon (10 mg), when used as a daytime sleep aid, causes drowsiness (and related symptoms) up to 3 h postdose, and may impact task performance, especially more complex tasks, for at least 2-3 h postdose.
Authors: Maartje H de Groot; Jos P C M van Campen; Marije A Moek; Linda R Tulner; Jos H Beijnen; Claudine J C Lamoth Journal: Drugs Aging Date: 2013-11 Impact factor: 3.923