Efficacy and Safety of Lemborexant for Insomnia Patients With Nocturia—A Prospective Study

Abstract

Objectives

Nocturia is considered a clinical problem when nocturnal urinary frequency is two or more times. For affected patients, development of depression, falling, and increased mortality rate are matters of concern. The present study investigated the efficacy and safety of lemborexant for insomnia patients with nocturia.

Methods

Insomnia patients (Athens Insomnia Scale [AIS] ≥ 6) who typically awoke twice or more during the night to urinate and were examined at our institutions from June 2021 to December 2022 were enrolled. Each was administrated 5 mg of lemborexant, one tablet, daily for 4 weeks. Total AIS score, nocturia frequency, individual frequency-volume chart findings, and N-QOL score were examined before and after administration.

Results

Of the 37 patients recruited, 5 were excluded, thus 32 were enrolled and subjected to analyses. Following lemborexant therapy, the mean AIS total score was significantly decreased from 11.4 to 7.8 (p < 0.01) as was mean number of nocturia episodes from 3.4 to 2.3 (p < 0.001). Furthermore, the mean single voided urine volume at night was significantly increased from 182.5 to 225.3 mL (p < 0.001)and mean period of undisturbed sleep was significantly extended from 105.3 to 174.8 min (p < 0.001), while mean total N-QOL score was significantly improved from 49.6% to 64.8% (p < 0.001). As for adverse events, mild somnolence was observed in three cases.

Conclusions

Lemborexant may be effective and safe for use in insomniac patients with nocturia.