In pooled data analysis, participants treated with 5 or 10 mg of lemborexant (Eisai, Woodcliff Lake, NJ) had significantly decreased insomnia symptom severity compared with those treated with placebo. The severity of insomnia decreased to levels below the clinical threshold for insomnia in approximately one-third of individuals treated with lemborexant when assessed at 1 month of treatment. Decreases in insomnia severity in people treated with lemborexant were sustained over 6 months and were significantly larger in magnitude, compared with people treated with placebo.
Treatment with lemborexant resulted in significantly improved subjective measures of how long it took to fall asleep, how much time was spent awake after initially falling asleep, and overall efficiency of sleep (time asleep/time in bed). On average, participants who took lemborexant had more than 1 hour of additional sleep per night. A greater proportion of people taking lemborexant fell asleep more easily and stayed asleep compared with those taking placebo when measured (1 week and 1 month after initiated treatment).
It has also been shown that people who took lemborexant were also able to wake safely during the night in response to auditory stimuli and to return to sleep effectively. People treated with lemborexant also showed the ability to wake well the next morning, based on a real-world driving test. In this on-road driving test (with a driving safety instructor and dual controls), participants given lemborexant were not different from placebo on the measure of “weaving.”
Participants who were age 55 or more treated with lemborexant had greater increases in total nonREM sleep, REM sleep, and total sleep time compared with those given placebo.
Treatment with lemborexant (5, 10, or 25 mg) did not negatively affect mean SpO2 or apnea-hypopnea index (AHI) in healthy adult and elderly participants. Additionally, treatment with lemborexant in adults with mild obstructive sleep apnea had no negative effects on SpO2 or AHI.
Margaret Moline, PhD, International Project Team Lead for the lemborexant clinical development program said, “When selecting appropriate medications, it is important to balance efficacy and safety; patients should be able to fall asleep more easily, sleep longer, and wake well in the morning. We are excited to potential add another tool to clinicians for helping people with insomnia.”
These data were presented at SLEEP2019, the 33rd annual meeting of the Associated Professional Sleep Societies LLC (APSS), a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society and at the American Academy of Neurology 2019 annual meeting.
In pivotal phase 3 studies of lemborexant, treatment with lemborexant (5 or 10 mg) was shown more effective than placebo at improving objective (SUNRISE-1) and patient-reported (subjective; SUNRISE-1 and SUNRISE-2) measures of sleep onset and sleep maintenance. In the SUNRISE-1 trial (NCT02783729), participants with insomnia treated with lemborexant (5 or 10 mg) over a 1-month period and in SUNRISE-2 (NCT02952820) participants were treated over a 6-month period. In SUNRISE-1, treatment with lemborexant also resulted in greater improvements in objective sleep measures compared with treatment with zolpidem extended release.
Monideep Dutt, MD; Jamika Hallman-Cooper, MD; Ekta Bery, MD; Mohammed Shahnawaz, MD; and Grace Gombolay, MD
F. Stephen Benesh, MD, and Shruti P. Agnihotri, MD
Fabio Fieni Toso, MD; Rene de Araújo Gleizer, MD; and Lívia Almeida Dutra, MD, PhD