Efficacy and safety of lemborexant in insomnia patients with nocturia.

Efficacy and safety of lemborexant in insomnia patients with nocturia. - Efficacy and safety of lemborexant in insomnia patients with nocturia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000044383

Enrollment

Registered

2021-05-31

Start date

2021-05-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia with nocturia

Interventions

Lemborexant 5 mg is orally administered for 4 weeks before sleep for insomnia patients who urinate twice or more during nighttime

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Insomnia patients who urinate twice or more during nighttime

Exclusion criteria

Exclusion criteria: Patients with polyuria and nocturnal polyuria. Patients with a history of hypersensitivity to the ingredients of this drug Patients with pyuria or bacteriuria Patients taking other insomnia medications Patients taking CYP3A inhibitors Patients with narcolepsy or cataplexy Patients with sleep apnea syndrome Patients with severe liver dysfunction or severe renal dysfunction

Design outcomes

Primary

Measure	Time frame
The change of Athens Insomnia Scale after 4 weeks of lemborexant treatment	—

Secondary

Measure	Time frame
The change of nocturnal urinary frequency, N-QOL after 4 weeks of lemborexant treatment and presence or absence of side effects within 4 weeks after starting oral administration	—

Countries

Japan

Contacts

Public ContactYoshikazu Togo

Kyowakai Medical Corporation Kyoritsu Hospital Department of urology

ytogohg@gmail.com072-758-1131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026