Lemborexant potential treatment option for midlife women with insomnia

A recent study published in the Menopause Journal found that lemborexant may offer a potential treatment option for midlife women struggling with insomnia.

Insomnia is a common sleep disorder that affects numerous individuals, particularly midlife women. To address this concern, Masakazu Terauchi and peers assessed the efficacy and safety of lemborexant (LEM), a competitive dual orexin receptor antagonist, as a potential treatment for insomnia in this specific population.

The study, known as E2006-G000-303 or SUNRISE-2, was a randomized, double-blind, placebo-controlled trial involving 949 adults midlife women aged 40 to 58, diagnosed with insomnia disorder. During the first six months of treatment, participants received either a placebo or varying doses of LEM, with options of 5 mg (LEM5) or 10 mg (LEM10). In the subsequent six-month period, participants who had initially received the placebo were re-randomized to either LEM5 or LEM10, while those in the LEM group continued their assigned dosage.

Assessments during the study included patient-reported measures related to sleep and fatigue, as well as the monitoring of treatment-emergent adverse events. The subgroup of midlife women comprised 280 participants, with approximately one-third in each treatment group.

At the six-month mark, the median changes from baseline in subjective sleep-onset latency, or the time it takes to fall asleep, were significantly reduced in both LEM groups compared to the placebo.

Participants in the LEM5 group experienced a median decrease of 20.7 minutes, while those in the LEM10 group saw a reduction of 30.4 minutes. Moreover, subjective wake after sleep onset, an indicator of interrupted sleep, showed substantial improvements in the LEM groups compared to the placebo. These positive trends persisted throughout the 12-month duration of the study.

Midlife women treated with LEM demonstrated greater improvements in insomnia severity and fatigue compared to those who received the placebo. Importantly, the treatment was generally well tolerated, with most reported adverse events being mild to moderate in severity. Further research and clinical trials will be necessary to validate these results and explore the long-term effects of LEM on this specific population.

Reference:

Terauchi, M., Cheng, J. Y., Yardley, J., Pinner, K., Moline, M., Malhotra, M., Inabe, K., Nishida, M., & Pappadopulos, E. (2023). Efficacy and safety of lemborexant in midlife women with insomnia disorder. In Menopause: Vol. Publish Ahead of Print. Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1097/gme.0000000000002209