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

NCT07840638 | Not Yet Recruiting Phase 4

• 1 other identifier: LENS Study
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nocturia

Keywords

Nocturia; Lemborexant; Randomised Cross Over Trial

Outcome Measures

Primary Outcomes (1)

• Change in mean nocturia episodes per 24 hours

  Change in mean nocturia episodes per 24 hours, measured by a 7-day/night bladder diary between baseline and the end of each treatment period. Participants will record the time and volume of each void (day and night) for 7 consecutive days at baseline (prior to randomization) and at week 6 (the final treatment weeks: days 35-42) of each treatment period.

  42 Days

Secondary Outcomes (7)

• Change in Epiworth Sleepiness Scale (ESS)

  42 days

• Change in nocturia associated quality of life

  42 days

• Change in Insomnia Severity Index (ISI)

  42 days

• Change in mean reported first uninterrupted sleep period (FUSP)

  42 days

• Change in mean nocturia urinary frequency

  42 days

Study Arms (2)

Sequence A: Lemborexant then Placebo

EXPERIMENTAL

Lemborexant at bedtime for 6 weeks (5 mg weeks 1-3), optional uptitration to 10 mg (weeks 4-6), and then 2 week washout, then matching placebo for 6 weeks.

Drug: Lemborexant tablets

Sequence B: Placebo then Lemborexant

EXPERIMENTAL

Matching placebo at bedtime for 6 weeks (1 tablet weeks 1-3, optional increase to 2 tablets weeks 4-6), then 2 week washout, then Lemborexant for 6 weeks

Drug: Placebo

Interventions

Lemborexant tablets DRUG

5mg (one tablet) orally at bedtime for weeks 1-3, with optional uptitration to 10mg (two tablets) for weeks 4-6.

Also known as: Dayvigo

Sequence A: Lemborexant then Placebo

Placebo DRUG

Matching placebo tablet, one at bedtime weeks 1-3, optionally two for weeks 4-6 to preserve masking

Sequence B: Placebo then Lemborexant

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years
• Has nocturia as determined by ICS criteria (ICIQ-N)
• Has Nocturia, after 4 weeks of conservative treatment (fluid advice, leg elevation, sodium restriction, medication review, mild compression stockings where relevant), indicates a score of ≥4 on question 4b of the validated ICIQ Nocturia module \[https://iciq.net/iciq-n\] - (indication of bother rating of 4-10)

You may not qualify if:

• Participant has a 24h polyuria (\>3L), measured by a 7-day bladder diary
• Participant has a post-void residual (\>250mL), measured by ultrasound following void from a comfortably full bladder
• The participant has known untreated sleep apnoea, or highly likely OSA according to the validated STOP-BANG questionnaire (score 5-8)
• The participant has significant heart failure (NYHA C/D)
• The participant has severe renal impairment (eGFR \<30mL/min), severe hepatic impairment (Child-Pugh class 3)
• The participant is taking hypnotics
• The participant is taking strong CYP3A inducers such as rifampin, carbamazepine, St. John's wort
• The participant has a known drug allergy to Lemborexant or its constituents
• The participant has cognitive impairment of a degree which, in the opinion of the investigator, is likely to impair the ability to adhere to trial requirements
• The participant is unwilling to abstain from alcohol consumption for the period of the study

Sponsors & Collaborators

• Eisai Inc.: collaborator
• University of Alberta: lead

Study Sites (1)

Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp Edmonton

Edmonton, Alberta, T6G 2P4, Canada

Location

Related Publications (12)

• 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.

  PMID: 40083090 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.

  PMID: 30675816 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.

  PMID: 33081593 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.

  PMID: 21661016 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.

  PMID: 31364920 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.

  PMID: 40900851 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.

  PMID: 30779378 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.

  PMID: 31310770 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.

  PMID: 11857672 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.

  PMID: 32585700 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.

  PMID: 35748777 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.

  PMID: 39389787 BACKGROUND

MeSH Terms

Conditions

Nocturia

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Adrian S Wagg, MD

CONTACT

780-492-5338; adrian.wagg@ualberta.ca

William Gibson, MD

CONTACT

780 492 0133; wgibson@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): July 20, 2030
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)