PSUN201 Efficacy and Safety of Lemborexant in Diabetic Patients With Insomnia Disorder

BACKGROUND: Patients with diabetes report sleep problems more often than healthy individuals. Notably, ∼50% of the patients with Type 2 diabetes have reported insomnia. However, literature on the efficacy and safety of commonly prescribed sleep promoting drugs in this patient group is limited. Lemborexant (LEM) is a dual orexin receptor antagonist approved in multiple countries for the treatment of adults with insomnia. In Study 303 (NCT02952820), LEM provided significant benefit on subject-reported sleep measures versus placebo (PBO). This analysis evaluated sleep diary-based efficacy and safety of LEM over 12mo in the subgroup of participants with diabetes. METHODS: Study 303 was a 12mo randomized, double-blind, PBO-controlled (first 6mo [Period 1]), phase 3 study in participants ≥18y with insomnia disorder and baseline Insomnia Severity Index total score ≥15. Patients with diabetes Type 1 or Type 2, identified by concomitant medications, were allowed to participate as long as their condition was considered stable and likely to be so during the year of treatment. During Period 1, participants received LEM 5mg (LEM5), LEM 10mg (LEM10), or PBO. During Period 2 (second 6mo), LEM participants continued their assigned dose and PBO participants were rerandomized to LEM5 or LEM10. Outcome measures included patient-reported (subjective [s]) sleep onset latency (sSOL), wake after sleep onset (sWASO), sleep efficiency (sSE), and total sleep time (sTST). Treatment-emergent adverse events (TEAEs) were assessed. RESULTS: The diabetic subgroup included 72/949 participants (Period 1: PBO, n=24; LEM5, n=26; LEM10, n=22). The majority of the participants were White (56/72 [77.8%]) and female (51/72 [70.8%]); 8/72 [11.1%] were Asian and 7/72 [9.7%] were Black. Mean age for PBO, LEM5 and LEM10 was 63.8y, 60.2y and 63.5y, respectively. The most common concomitant medication classes taken by participants were alimentary tract and metabolism. Overall, sleep-related outcomes at 6mo in participants with diabetes were consistent with the full study population. sSOL change from baseline (median) at 6mo was -10.77, -20.71, and -30.71 minutes for PBO, LEM5 and LEM10, respectively. Mean (SD) change from baseline at 6mo was for sWASO: PBO, -32.16 [36.93], LEM5, -43.80 [57.27], and LEM10, -57.55 [65.16]; for sSE: PBO, 8.06 [8.41]; LEM5, 13.20 [10.66], and LEM10, 18.08 [15.76]; and for sTST: PBO, 47.36 [59.76]; LEM5, 73.35 [56.0]; and LEM10, 86.32 [76.49]. Most TEAEs were mild or moderate and consistent with the known safety profile of LEM. The most common TEAE was somnolence reported in 4.2, 3.8, 13.6% for PBO, LEM5 and LEM10, respectively. CONCLUSIONS: Long-term treatment with lemborexant appears effective in improving sleep onset and sleep maintenance variables in diabetic patients with insomnia, consistent with the overall study population. Furthermore, LEM was well-tolerated, and no new safety signals were observed in participants with diabetes, supporting LEM as a potential treatment option. Support: Eisai Inc. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.