Lemborexant potential treatment option for midlife women with insomnia

Written By : Jacinthlyn Sylvia |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2023-07-21T20:30:43+05:30 | Updated On 21 July 2023 8:31 PM IST

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

Source : The Journal of the North American Menopause Society

Jacinthlyn Sylvia

Neuroscience Masters graduate

Jacinthlyn Sylvia, a Neuroscience Master's graduate from Chennai has worked extensively in deciphering the neurobiology of cognition and motor control in aging. She also has spread-out exposure to Neurosurgery from her Bachelor’s. She is currently involved in active Neuro-Oncology research. She is an upcoming neuroscientist with a fiery passion for writing. Her news cover at Medical Dialogues feature recent discoveries and updates from the healthcare and biomedical research fields. She can be reached at editorial@medicaldialogues.in

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751