OBJECTIVE: Next-day residual effects of a nighttime dose of gabapentin 250 mg were evaluated on simulated driving performance in healthy participants in a randomized, placebo-controlled, double-blind, multicenter, four-period crossover study that included diphenhydramine citrate 76 mg and triazolam 0.5 mg. METHODS: At treatment visits, participants (n = 59) were dosed at ~23:30, went to bed immediately, and awakened 6.5 h postdose for evaluation. The primary endpoint was the standard deviation of lateral position for the 100-km driving scenario. Additional measures of driving, sleepiness, and cognition were included. RESULTS: Study sensitivity was established with triazolam, which demonstrated significant next-day impairment on all driving endpoints, relative to placebo (p < 0.001). Gabapentin demonstrated noninferiority to placebo on standard deviation of lateral position and speed deviation but not for lane excursions. Diphenhydramine citrate demonstrated significant impairment relative to gabapentin and placebo on speed deviation (p < 0.05). Other comparisons were either nonsignificant or statistically ineligible per planned, sequential comparisons. Secondary endpoints for sleepiness and cognitive performance were supportive of these conclusions. CONCLUSIONS: Together, these data suggest that low-dose gabapentin had no appreciable next-day effects on simulated driving performance or cognitive functioning.
RCT Entities:
OBJECTIVE: Next-day residual effects of a nighttime dose of gabapentin 250 mg were evaluated on simulated driving performance in healthy participants in a randomized, placebo-controlled, double-blind, multicenter, four-period crossover study that included diphenhydramine citrate 76 mg and triazolam 0.5 mg. METHODS: At treatment visits, participants (n = 59) were dosed at ~23:30, went to bed immediately, and awakened 6.5 h postdose for evaluation. The primary endpoint was the standard deviation of lateral position for the 100-km driving scenario. Additional measures of driving, sleepiness, and cognition were included. RESULTS: Study sensitivity was established with triazolam, which demonstrated significant next-day impairment on all driving endpoints, relative to placebo (p < 0.001). Gabapentin demonstrated noninferiority to placebo on standard deviation of lateral position and speed deviation but not for lane excursions. Diphenhydramine citrate demonstrated significant impairment relative to gabapentin and placebo on speed deviation (p < 0.05). Other comparisons were either nonsignificant or statistically ineligible per planned, sequential comparisons. Secondary endpoints for sleepiness and cognitive performance were supportive of these conclusions. CONCLUSIONS: Together, these data suggest that low-dose gabapentin had no appreciable next-day effects on simulated driving performance or cognitive functioning.
Authors: Shelby Hughes; Daniel O Claassen; Wery P M van den Wildenberg; Fenna T Phibbs; Elise B Bradley; Scott A Wylie; Nelleke C van Wouwe Journal: J Int Neuropsychol Soc Date: 2018-12-03 Impact factor: 2.892
Authors: Rowan P Ogeil; Laura K Barger; Steven W Lockley; Conor S O'Brien; Jason P Sullivan; Salim Qadri; Dan I Lubman; Charles A Czeisler; Shantha M W Rajaratnam Journal: BMJ Open Date: 2018-09-19 Impact factor: 2.692
Authors: Eric M Pearlman; Darren Wilbraham; Ellen B Dennehy; Paul H Berg; Max Tsai; Erin G Doty; Gary G Kay Journal: Hum Psychopharmacol Date: 2020-05-25 Impact factor: 1.672
Authors: Stewart J Tepper; Stephen D Silberstein; Noah L Rosen; Richard B Lipton; Ellen B Dennehy; Sherie A Dowsett; Erin Doty Journal: Headache Date: 2019-12-02 Impact factor: 5.887