Residual effects of evening and middle-of-the-night administration of zaleplon 10 and 20 mg on memory and actual driving performance

Abstract

Zaleplon, a new pyrazolopyrimidine hypnotic, possesses an unusually short elimination half-life (ca 1 h). This study was conducted to determine whether middle-of-the-night administration of zaleplon aects memory or driving performance the following morning. Twenty-eight healthy volunteers participated in a double-blind, 7-way, crossover study. They ingested capsules twice on each treatment night; once before initiating sleep and again after being brie¯y awakened 5 h later. Treatments were: placebo at both times, zaleplon 10 or 20 mg, or zopiclone 7 . 5 mg followed by placebo, or the same in reverse order. Subjects arose 3 h after the second dose. One hour later, sleep quality and mood were assessed by questionnaires and balance and memory in a test battery. A standardized actual driving test was undertaken between 5 and 6 h after the second dose. All drugs similarly improved sleep quality, but only zopiclone hindered awakening. Evening zaleplon doses were without signi®cant eects. Late-night zaleplon had minor eects in one memory test. Evening zopiclone shared these eects and also signi®cantly impaired driving performance. Late-night zopiclone's eects were signi®cant in every test. Its eects on driving were severe. The results suggest that zaleplon 10 mg certainly, and 20 mg probably, can be taken at bedtime or later in the night, up to 5 h before driving with little risk of serious impairment. #

Hypnotics and Driving Safety: Meta-Analyses of Randomized Controlled Trials Applying the on-the-Road Driving Test

“…Ten studies [10][11][12][13][14][15][16][17][18] (labeled Study 1-10 in the text and Tables) were identified that met all inclusion criteria for the meta-analyses. Study characteristics are summarized in Table 1.…”

“…Six studies [10][11][12][13][14] (Study 1-6) were performed in the 1980s and examined the effects of benzodiazepines and zopiclone after two nights of bedtime administration. Three studies [15][16][17] (Study 7-9) examined the effects of zopiclone, zolpidem and zaleplon after one night of bedtime administration. Two studies [16,18] (Study 8 and 10) also examined zolpidem and zaleplon after middle-of-the-night administration.…”

“…Three studies [15][16][17] (Study 7-9) examined the effects of zopiclone, zolpidem and zaleplon after one night of bedtime administration. Two studies [16,18] (Study 8 and 10) also examined zolpidem and zaleplon after middle-of-the-night administration. In all studies, subjects were trained to become familiar with the vehicle and testing procedures.…”

“…Tests were performed in the morning, i.e. 10-11 hours after dosing (Study 1-10) [10][11][12][13][14][15][16][17][18], or in the afternoon, i.e. 16-17 hours after dosing (Study 1-6) [10][11][12][13][14].…”

A Laboratory Evaluation of Performance Following a Daytime Nap Under Zaleplon and Placebo Conditions

“…Additionally, Troy, Lucki, Unruh, Cevallos, Leister, Martin, Furlan, and Mangano (2000) showed no significant performance differences between placebo and 10-mg zaleplon 1.25 hours post-dose. However, Vermeeren, Danjou, & O'Hanlon (1998) found a significantly degraded memory effect at 6.5 hours after a single dose administration of both 10-mg and 20-mg zaleplon. Allen, Curran, & Lader (1993), tested normal participants after a 20-mg dose of zaleplon and found most performance at 3-hrs post-dose to be "generally similar to performance on placebo."…”