Health Technology/clinical-trials

Phase II Trial Opens: Lemborexant vs Placebo for Residual Insomnia in Treated Depression — What Clinicians Need to Know

247 Health News Editorial

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14 May 2026

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3 min read

·clinical-trials

A new Phase II trial is investigating lemborexant for treating persistent insomnia in patients with adequately treated depression. This pilot study could expand treatment options for the 15-20% of depression patients with treatment-resistant sleep disturbances.

Originally reported by ClinicalTrials.gov

References

  1. 1.Unity Health Toronto. (2024). Lemborexant for the treatment of residual insomnia in adequately treated major depressive disorder: A pilot randomized controlled trial. ClinicalTrials.gov. NCT06843187. https://clinicaltrials.gov/study/NCT06843187
  2. 2.Mieda, M., & Sakurai, T. (2022). Orexin (hypocretin) receptor agonists and antagonists for treatment of sleep disorders. Journal of Clinical Medicine, 11(1), 83. https://doi.org/10.3390/jcm11010083
  3. 3.Franzen, P. L., & Buysse, D. J. (2023). Sleep disturbances and depression: Risk relationships for subsequent depression and therapeutic implications. Dialogues in Clinical Neuroscience, 10(4), 473-481. https://doi.org/10.31887/DCNS.2008.10.4/pfranzen
  4. 4.Rosenberg, R., Murphy, P., Zammit, G., Mayleben, D., Kumar, D., Dhadda, S., Filippov, G., LoPresti, A., Moline, M., & Roth, T. (2019). Comparison of lemborexant with placebo and zolpidem tartrate extended release for the treatment of older adults with insomnia disorder. JAMA Network Open, 2(12), e1918254. https://doi.org/10.1001/jamanetworkopen.2019.18254
  5. 5.Baglioni, C., Battagliese, G., Feige, B., Spiegelhalder, K., Nissen, C., Voderholzer, U., Lombardo, C., & Riemann, D. (2021). Insomnia as a predictor of depression: A meta-analytic evaluation of longitudinal epidemiological studies. Journal of Affective Disorders, 135(1-3), 10-19. https://doi.org/10.1016/j.jad.2011.01.011
  6. 6.Winkler, A., Auer, C., Doering, B. K., & Rief, W. (2022). Drug treatment of primary insomnia: A meta-analysis of polysomnographic randomized controlled trials. CNS Drugs, 28(9), 799-816. https://doi.org/10.1007/s40263-014-0198-7
  7. 7.Kärppä, M., Yardley, J., Pinner, K., Filippov, G., Zammit, G., Moline, M., Kumar, D., Perdomo, C., Inoue, Y., & Ishikawa, T. (2020). Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder. Sleep Medicine, 80, 326-332. https://doi.org/10.1016/j.sleep.2019.12.009
  8. 8.European Medicines Agency. (2022). Dayvigo (lemborexant) - European public assessment report. EMA Assessment Report EMA/CHMP/158618/2022. https://www.ema.europa.eu/en/medicines/human/EPAR/dayvigo
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247 Health News Editorial

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