Comparison of the treatment effectiveness between lemborexant and zolpidem tartrate extended release for insomnia disorder subtypes defined based on polysomnographic findings.

STUDY OBJECTIVES
Patients with chronic insomnia may respond differently to therapeutic modalities. This study examined differences in response of individuals with two insomnia phenotypes: short sleep duration (I-SSD, <6 hours) and normal sleep duration (I-NSD, ≥6 hours) determined by polysomnography (PSG), to treatment with lemborexant and zolpidem tartrate extended-release 6.25 mg (zolpidem ER), compared with placebo.


METHODS
Study E2006-G000-304 (Study 304; SUNRISE-1; NCT02783729) was a global, randomized, double-blind, placebo and active comparator-controlled, parallel-group study comparing lemborexant 5 and 10 mg in individuals aged ≥55 years with insomnia disorder. In this analysis, changes in subjective variables based on sleep diaries and objective variables based on PSGs were assessed after 1-month administration of study drugs. Data from subjects with I-SSD and I-NSD were compared.


RESULTS
In the I-SSD subgroup, both lemborexant doses provided significant benefit for sleep onset latency (SOL), total sleep time (TST), and wake after sleep onset (WASO) versus placebo; zolpidem ER also provided significant benefit for TST and WASO, but not SOL, on both measures versus placebo. In the I-NSD subgroup, lemborexant and zolpidem ER provided significant benefit for TST and WASO versus placebo objectively, but not subjectively; both doses of lemborexant provided significant benefit for SOL versus placebo subjectively, but not objectively.


CONCLUSIONS
Both drugs, but lemborexant more consistently, showed subjective and objective benefits compared to placebo in insomnia subjects with objective short sleep duration. However, neither LEM nor ZOL provided consistent benefits for subjects with normal sleep duration on sleep onset and sleep maintenance variables.


CLINICAL TRIAL REGISTRATION
Registry: ClinicalTrials.gov; Title: Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1); Identifier: NCT02783729; URL: https://clinicaltrials.gov/ct2/show/record/NCT02783729.