Poster
127
(#127) Effect of Lemborexant in Patients With Insomnia Comorbid With Depressive Episodes (SELENADE Study)
Psych Congress 2025
Abstract: Objective: Determine the efficacy of lemborexant (LEM) in patients with insomnia associated with depressive episodes.
Methods: This multicenter, prospective intervention study enrolled patients with insomnia diagnosed with major depressive disorder (MDD) or bipolar disorder (BD) receiving stable antidepressant treatment. MDD add-on (n=29) and BD add-on (n=15) cohorts included participants with prior medication for insomnia; MDD mono (n=23) and BD mono (n=15) cohorts included participants without concomitant hypnotic medication. LEM starting dose was 5 mg and could be titrated up/down. Primary endpoint: change from baseline (CFB) in Insomnia Severity Index (ISI) at week 4. Secondary endpoints: CFB at 12 weeks in both ISI and depressive symptoms.
Results: For MDD add-on, MDD mono, BD add-on, and BD mono cohorts, the mean ISI total score at baseline was 14.5, 13.2, 13.5, and 11.8, respectively. At 4 weeks, mean CFB (95% confidence interval) was −2.3 (−3.9, −0.7), −3.2 (−5.0, −1.3), −5.2 (−7.9, −2.5), and −4.5 (−6.3, −2.6), respectively; improvements were maintained through 12 weeks. Baseline mean Hamilton Depression Rating Scale score was 13.6, 12.6, 13.9, and 11.4, respectively. At 12 weeks, the mean CFB (95% CI) was −6.4 (−7.8, −4.9)，−6.2 (−7.7, −4.6), −5.2 (−8.4, −2.1), and −5.4 (−7.2, −3.5), respectively. All adverse events were mild to moderate and consistent with the known safety profile of LEM.
Conclusions: LEM was effective for treating insomnia and improved depression in patients with insomnia and depression.
Acknowledgments: Medical writing assistance: Julianne Hatfield, PhD, of Peloton Advantage, LLC, an OPEN Health company, and funded by Eisai, Inc.
Short Description: The efficacy and safety of lemborexant, which is approved for adults with insomnia disorder, were examined in participants with insomnia with ongoing major depressive disorder or bipolar disorder receiving stable treatment for the depressive episodes. Lemborexant treatment improved both the Insomnia Severity Index and the Hamilton Depression Rating Scale over 12 weeks of treatment. These results suggest the effectiveness of lemborexant for insomnia comorbid with depressive episodes.
Name of Sponsoring Organization(s): Eisai, Inc.
Methods: This multicenter, prospective intervention study enrolled patients with insomnia diagnosed with major depressive disorder (MDD) or bipolar disorder (BD) receiving stable antidepressant treatment. MDD add-on (n=29) and BD add-on (n=15) cohorts included participants with prior medication for insomnia; MDD mono (n=23) and BD mono (n=15) cohorts included participants without concomitant hypnotic medication. LEM starting dose was 5 mg and could be titrated up/down. Primary endpoint: change from baseline (CFB) in Insomnia Severity Index (ISI) at week 4. Secondary endpoints: CFB at 12 weeks in both ISI and depressive symptoms.
Results: For MDD add-on, MDD mono, BD add-on, and BD mono cohorts, the mean ISI total score at baseline was 14.5, 13.2, 13.5, and 11.8, respectively. At 4 weeks, mean CFB (95% confidence interval) was −2.3 (−3.9, −0.7), −3.2 (−5.0, −1.3), −5.2 (−7.9, −2.5), and −4.5 (−6.3, −2.6), respectively; improvements were maintained through 12 weeks. Baseline mean Hamilton Depression Rating Scale score was 13.6, 12.6, 13.9, and 11.4, respectively. At 12 weeks, the mean CFB (95% CI) was −6.4 (−7.8, −4.9)，−6.2 (−7.7, −4.6), −5.2 (−8.4, −2.1), and −5.4 (−7.2, −3.5), respectively. All adverse events were mild to moderate and consistent with the known safety profile of LEM.
Conclusions: LEM was effective for treating insomnia and improved depression in patients with insomnia and depression.
Acknowledgments: Medical writing assistance: Julianne Hatfield, PhD, of Peloton Advantage, LLC, an OPEN Health company, and funded by Eisai, Inc.
Short Description: The efficacy and safety of lemborexant, which is approved for adults with insomnia disorder, were examined in participants with insomnia with ongoing major depressive disorder or bipolar disorder receiving stable treatment for the depressive episodes. Lemborexant treatment improved both the Insomnia Severity Index and the Hamilton Depression Rating Scale over 12 weeks of treatment. These results suggest the effectiveness of lemborexant for insomnia comorbid with depressive episodes.
Name of Sponsoring Organization(s): Eisai, Inc.
