Patients with insomnia can successfully transition directly from zolpidem to lemborexant, according to results from a recent open-label pilot study.

The findings were presented in a poster presentation at the Associated Professional Sleep Societies' Virtual SLEEP 2021 meeting.

“Subjects’ chief complaints about their sleep while taking Zolpidem, most subjects were bothered by waking too early and/or difficulty staying asleep,” explained Russell Rosenberg, PhD, D.ABSM, NeuroTrials Research, Inc., Atlanta, Georgia. “Prime focus of this study beyond the ability to transition to lemborexant was to evaluate whether these symptoms would be improved with lemborexant treatment.”

The study examined dosing paradigms for transitioning adult patients with insomnia from zolpidem immediate or extended release to 5mg or 10 mg of lemborexant, a dual orexin receptor antagonist.

A total of 53 participants were divided into two study cohorts; Cohort-1 consisting of intermittent zolpidem users who were assigned to a two-week titration period of 5mg lemborexant; and cohort-2 consisting of frequent zolpidem users randomized 1:1 to 5mg of lemborexant or 10 mg of lemborexant.

The primary endpoint was participants who transitioned to lemborexant at the end of the 2-week titration period.

Participants who experienced success under lemborexant were given the opportunity to enter a 12-week extension period.

Of the 53 participants, 43 or 81% transitioned to lemborexant following the 2-week titration period. A total of 38 participants entered the 12-week extension period.

In addition to successful transitions, subjects saw improvement of these symptoms under lemborexant.

Lemborexant was generally well-tolerated and safety profile was found to be consistent with existing clinical trial data

“Study results support the view that patients can successfully transition directly from ZOL (zolpidem) to LEM (lemborexant),” concluded Dr Rosenberg, et al.

--Erin McGuinness

Rosenberg, R, Amchin, J, et al. Evaluation of Dose Transition from Zolpidem to Lemborexant Across 14 Weeks: Results From a Multicenter Open-label Pilot Study. Presented at the Associated Professional Sleep Societies' Virtual SLEEP 2021 Meeting. June 10-13 2021; Virtual.