Sublingual Zolpidem (Edluar™; Sublinox™)

Abstract

Zolpidem is a non-benzodiazepine hypnotic used in the short-term treatment of insomnia. A sublingual orally disintegrating tablet formulation of zolpidem (Edluar™; Sublinox™) has been developed to provide a more rapid onset of action than oral immediate-release zolpidem. Sublingual zolpidem has demonstrated bioequivalence to oral zolpidem. In a randomized, double-blind, double-dummy, crossover, multi-centre study in adult patients with primary insomnia (n=70), a single 10-mg dose of sublingual zolpidem significantly reduced latency to persistent sleep (primary endpoint) compared with a single 10-mg dose of oral immediate-release zolpidem. Sleep-onset latency and latency to stage 1 sleep were also significantly shorter with sublingual zolpidem than with oral zolpidem. Moreover, compared with the oral formulation, sublingual zolpidem was noninferior in terms of total sleep time and did not significantly differ in terms of duration of wake after sleep onset. Sublingual zolpidem was generally well tolerated in this trial, with most adverse events being of mild or moderate severity. The overall tolerability profile of sublingual zolpidem was similar to that of oral zolpidem.