Lemborexant Shows Promise for Patients With Insomnia Short Sleep Who Do Not Respond to CBT–Insomnia

The current study aimed to assess rates of response and remission with Lemborexant based on the Insomnia Severity Index in the insomnia short sleep subgroup.

Lemborexant (LEM) may benefit patients with insomnia short sleep (ISS) who do not respond to cognitive behavioral therapy–insomnia (CBT-I), according to research recently presented at the 2022 Annual Meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held from June 4 to 8, 2022, in Charlotte, North Carolina.

Phase 3 Study 304 indicated LEM is beneficial for patients with insomnia compared with placebo (PBO), based on polysomnographic (PSG) and sleep diary-based sleep onset and maintenance outcomes seen over 1 month. In that study, Insomnia Severity Index (ISI) was used for inclusion criteria and outcome measure. Participants had insomnia with objective short sleep (total sleep time [TST] less than 6 hours) or objective long sleep (TST of at least 6 hours). Patients with ISS may respond more poorly to CBT-I. The current study aimed to assess rates of response and remission with LEM based on ISI in the ISS subgroup.

Women aged at least 55 years and men aged at least 65 years participated in Study 304, a 1-month, randomized, double-blind PBO- and active-controlled, parallel-group analysis that included 1006 individuals. Participants ingested PBO, LEM 5 mg (LEM5), LEM 10 mg (LEM10), or zolpidem tartrate extended-release 6.25 mg. About 71% (n=525) of individuals in the PBO/LEM groups were in the ISS subgroup.

The researchers obtained PSGs during a single-blind PBO at baseline and paired PSGs on Nights ½ and Nights 29/30. Participants completed the ISI at baseline and end of treatment.

The investigators found that responder and remitter rates for LEM5 (56.25% responders 27.84% remitters) and LEM10 (53.89% responders 27.78% remitters) exceeded those for PBO (42.14% responders 15% remitters).

“Older adults with ISS achieved clinically meaningful improvement with LEM as assessed at the end of 1 month with treatment, with nearly 30% considered remitters and >50% considered treatment responders,” the researchers noted. “LEM is a potential therapy for ISS patients who may have limited response to CBT-I.”

Disclosure: This research was supported by Eisai Inc. Please see the original reference for a full list of disclosures.


Edinger J, Krystal A, Kumar D, Pappadopulos E, Malhotra M, Moline M. Lemborexant treatment of older adults with insomnia and objective short sleep: rates of response and remission. Presented at SLEEP 2022; June 4-8; Charlotte, North Carolina. Abstract 451.