How Well and Safely Does Lemborexant Work for People Who Wake up at Night to Urinate (LENS)

Summary

Nocturia is defined by doctors as getting up one or more times a night to use the bathroom, where you were asleep before going to use the washroom and then going back to sleep afterward. People who experience this condition describe it was one of their biggest problems. This condition is very common as people get older and can seriously affect older peoples quality of life including disruptions to sleep, daily functioning, risk of falls and even early death.

Timeline

Start

2026-10-15

Primary completion

2029-11-30

Completion

2030-07-20

Publications

• Background Lederer K, Benes H, Fine A, Shoffner S, Bacchelli S, Diaz DC, Batista JE, Rowles R, Marco TD, Meinel M. A randomised crossover trial of daridorexant for the treatment of chronic insomnia and nocturia. J Sleep Res. 2025 Dec;34(6):e70002. doi: 10.1111/jsr.70002. Epub 2025 Mar 13.
• Background Dmochowski R, Brucker BM, Cole E, Kawahara S, Pulicharam R, Burk C, Tung A, Hale D. Economic Burden of Illness in Adult Patients with Nocturia. J Manag Care Spec Pharm. 2019 May;25(5):593-604. doi: 10.18553/jmcp.2019.18067. Epub 2019 Jan 24.
• Background Rahman SN, Cao DJ, Monaghan TF, Flores VX, Vaysblat M, Moy MW, Agudelo CW, Lazar JM, Weiss JP. Phenotyping the Association between Nocturia and Hypertension: A Systematic Review and Meta-Analysis. J Urol. 2021 Jun;205(6):1577-1583. doi: 10.1097/JU.0000000000001433. Epub 2020 Oct 20.
• Background Weiss JP, Wein AJ, van Kerrebroeck P, Dmochowski R, Fitzgerald M, Tikkinen KA, Abrams P. Nocturia: new directions. Neurourol Urodyn. 2011 Jun;30(5):700-3. doi: 10.1002/nau.21125.
• Background Pesonen JS, Cartwright R, Vernooij RWM, Aoki Y, Agarwal A, Mangera A, Markland AD, Tsui JF, Santti H, Griebling TL, Pryalukhin AE, Riikonen J, Tahtinen RM, Vaughan CP, Johnson TM 2nd, Auvinen A, Heels-Ansdell D, Guyatt GH, Tikkinen KAO. The Impact of Nocturia on Mortality: A Systematic Review and Meta-Analysis. J Urol. 2020 Mar;203(3):486-495. doi: 10.1097/JU.0000000000000463. Epub 2019 Jul 31.
• Background Hou XY, Zhang L, Zhang ZJ, Xu W, Ye LW, Zhao HY, Suo XH, Hong AJ. Nocturia: An overview of current evaluation and treatment strategies. World J Methodol. 2025 Dec 20;15(4):104696. doi: 10.5662/wjm.v15.i4.104696. eCollection 2025 Dec 20.
• Background Everaert K, Herve F, Bosch R, Dmochowski R, Drake M, Hashim H, Chapple C, Van Kerrebroeck P, Mourad S, Abrams P, Wein A. International Continence Society consensus on the diagnosis and treatment of nocturia. Neurourol Urodyn. 2019 Feb;38(2):478-498. doi: 10.1002/nau.23939. Epub 2019 Feb 19.
• Background Bliwise DL, Wagg A, Sand PK. Nocturia: A Highly Prevalent Disorder With Multifaceted Consequences. Urology. 2019 Nov;133S:3-13. doi: 10.1016/j.urology.2019.07.005. Epub 2019 Jul 13.
• Background van Kerrebroeck P, Abrams P, Chaikin D, Donovan J, Fonda D, Jackson S, Jennum P, Johnson T, Lose G, Mattiasson A, Robertson G, Weiss J; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology in nocturia: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):179-83. doi: 10.1002/nau.10053. No abstract available.
• Background Karppa M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. doi: 10.1093/sleep/zsaa123.
• Background Landry I, Hall N, Alur J, Filippov G, Reyderman L, Setnik B, Henningfield J, Moline M. Acute Cognitive Effects of the Dual Orexin Receptor Antagonist Lemborexant Compared With Suvorexant and Zolpidem in Recreational Sedative Users. J Clin Psychopharmacol. 2022 Jul-Aug 01;42(4):374-382. doi: 10.1097/JCP.0000000000001562. Epub 2022 Jun 24.
• Background Togo Y, Kaizuka Y, Nagasawa S, Kajio K, Kondoh N, Taguchi K. Efficacy and Safety of Lemborexant for Insomnia Patients With Nocturia-A Prospective Study. Low Urin Tract Symptoms. 2024 Nov;16(6):e12534. doi: 10.1111/luts.12534.

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