Lemborexant versus Zolpidem: An Assessment of Wake Bouts in Adults with Insomnia
Recommended Citation
Roth T, Zammit G, Kumar D, Pappadopulos E, Moline M. Lemborexant versus Zolpidem: An Assessment of Wake Bouts in Adults with Insomnia. Sleep Med 2022; 100:S128-S129.
Document Type
Conference Proceeding
Publication Date
12-1-2022
Publication Title
Sleep Med
Abstract
Introduction: Dual orexin receptor antagonists (DORAs), including lemborexant (LEM), are thought to promote sleep by inhibiting orexin-mediated wakefulness. In Study 304 (SUNRISE-1; NCT02783729; ≥55 years with insomnia), LEM significantly improved sleep efficiency and wake after sleep onset (WASO) versus placebo (PBO) and zolpidem tartrate extended-release 6.25mg (ZOL). The precise effects of LEM on WASO dynamics were examined by evaluating the effect of LEM on frequency and duration of wake bouts. Materials and Methods: Study 304 was a 1 month, randomized, double-blind, PBO (n=208)- and active-controlled (ZOL; n=263) study of LEM 5mg (LEM5; n=266) and LEM 10mg (LEM10; n=269). Polysomnographic data from Night (NT) 2 and NT31 of treatment were analyzed to determine the number and total duration of all wake bouts (any duration), short (≤2 minutes) and long (>2 minutes) wake bouts. P-values are based on differences in least squares mean changes from baseline, in the number and total duration of all, short, and long wake bouts among treatment groups. Results: Wake bouts of any duration were more frequent in LEM-treated subjects during NT2, (LEM5, 35.1; LEM10, 37.8) versus PBO (32.7) or ZOL (31.5), and during NT31: 37.9, 40.3, 31.7, and 31.0, respectively. LEM-treated subjects spent fewer total minutes in wake bouts during NT2 (LEM5, 62.2; LEM10, 55.2) versus PBO (93.0) or ZOL (72.7) and during NT31: 66.4, 67.3, 92.4, and 79.7, respectively. LEM-treated subjects had more short wake bouts during NT2 (LEM5, 30.4; LEM10, 33.4) versus PBO (26.9) or ZOL (26.3) and during NT31: 32.8, 34.7, 26.1, and 25.9, respectively. LEM5- and LEM10-treated subjects spent significantly more minutes in short wake bouts than PBO- or ZOL-treated subjects during NT2 (LEM5, 22.0 [P<0.05 vs PBO and ZOL]; PBO, 20.1; and ZOL, 19.5; LEM10, 24.5 [P<0.0001 vs PBO and ZOL]). Findings were similar during NT31 (LEM5, 23.9; LEM10, 25.7 [both P<0.0001 vs PBO and ZOL]; PBO, 19.4; and ZOL, 19.3). ZOL was not significant versus PBO for total time spent in short wake bouts at either NT2 or NT31. LEM-treated subjects had fewer long wake bouts (LEM5, 4.7; LEM10, 4.4) versus PBO (5.9) or ZOL (5.2) during NT2 but were similar during NT31: 5.1, 5.6, 5.5, and 5.2, respectively. LEM5- and LEM10-treated subjects spent significantly fewer minutes in long wake bouts than PBO- or ZOL-treated subjects during NT2 (LEM5, 40.3; LEM10, 30.8 [both P<0.0001 vs PBO and ZOL]; PBO, 73.0; and ZOL, 53.2). Findings were similar during NT31: LEM5, 42.5; LEM10, 41.6 (both P<0.0001 vs PBO and ZOL); PBO, 73.0; and ZOL, 60.4. ZOL was significant versus PBO at NT2 and NT31 (both P<0.001). Conclusion: Relative to PBO and ZOL, WASO decreased with LEM, mediated by a decrease in the number and time spent in long wake bouts, and an increase in the number and time spent in short wake bouts. These findings are consistent with the effects of the DORA, suvorexant on WASO (Svetnik V, et al. SLEEP. 2018;41(1)) and reflect differences between hypnotics with different mechanisms of action. Acknowledgements: Supported by Eisai Inc.
Volume
100
First Page
S128
Last Page
S129
