OBJECTIVES

Untreated insomnia can lead to daytime fatigue and poor quality of life (QOL). This study assessed the changes in QOL at one month from baseline, using EQ-5D-3L collected in the SUNRISE-1 Phase-3 study of lemborexant, a dual-orexin-receptor-antagonist approved for the treatment of insomnia.

METHODS

Subjects were randomized to treatment with lemborexant-10mg (LEM10, n=269), 5mg (LEM5, n=266), placebo (n=208), or zolpidem extended-release 6.25mg (ZOL-ER, n=263). Responders on patient-reported (subjective), sleep diary-based sleep onset latency (sSOL) were defined as sSOL ≤20minutes at the end of one month of treatment, provided their baseline sSOL was >30minutes. Subjects did not have to meet criteria for sleep onset insomnia in this study. Exclusion criteria for the EQ-5D analysis: did not meet baseline criteria of sSOL>30minutes (n=230), missing sleep data (n=53), fall during the study (n=4), and/or missing EQ-5D data (n=19). EQ-5D-3L data were scored to QOL scores (utility values) using UK tariffs. ANCOVA detected the difference of QOL score changes from baseline between responder and non-responder groups using age, sex, baseline QOL scores, and comorbidities of depression or anxiety disorder histories as covariates.

RESULTS

Seven-hundred-and-three subjects were eligible for EQ-5D analysis with n=36, 44, 15, and 21 for LEM10, LEM5, placebo, and ZOL-ER in responder group, and n=143, 151, 125, and 168 in non-responder group, respectively, after the exclusions. Mean baseline QOL scores (SD) were 0.904 (0.157) in responder and 0.900 (0.154) in non-responder group. Increments of QOL scores from the baseline were 0.026 larger in responder group compared with non-responder group with no statistical significance (p=0.068). The subjects who were older, had higher baseline QOL score and had histories of depression tended to have lower QOL score changes (p<0.001).

CONCLUSIONS

Subjects who responded to the treatments for insomnia had larger improvement of QOL than those without responses, and the QOL increments were estimated 0.026 based on sSOL.