Preventive effects of lemborexant on postoperative delirium in patients with proximal femur fracture surgery and insomnia in the perioperative period: a double-blind, randomized, non-inferiority trial of lemborexant versus ramelteon

Preventive effects of lemborexant on postoperative delirium in patients with proximal femur fracture surgery and insomnia in the perioperative period: a double-blind, randomized, non-inferiority trial of lemborexant versus ramelteon - Preventive effects of lemborexant on postoperative delirium in patients with proximal femur fracture surgery and insomnia in the perioperative period: a double-blind, randomized, non-inferiority trial of lemborexant versus ramelteon

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042070

Enrollment

198

Registered

2020-10-12

Start date

2020-10-12

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

Postoperative delirium

Interventions

Lemborexant 5 mg will be orally administered once daily before bedtime. (1) If a patient agrees to participate in our study preoperatively: The primary outcome of our study (incidence of postopera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing proximal femur fracture surgery and experiencing insomnia Patients capable of giving voluntary written informed consent Male and female patients aged 65 years and above The patients are diagnosed with insomnia if sleep disturbance (difficulty falling asleep, awakening halfway, awakening early in the morning, etc.) and associated daytime symptoms (fatigue or malaise, daytime sleepiness, decreased attention/concentration/memory, etc.) are present at least three days a week (ICD11/DSM-5/ICSD-3). Additionally, patients who were already on sleeping pills at the time of obtaining informed consent are also diagnosed with insomnia.

Exclusion criteria

Exclusion criteria: Patients taking CYP1A2 inhibitors (quinolone antibacterial drug, fluvoxamine), CYP3A4 inhibitors (itraconazole, ketraconazole, fluconazole, verapamil, macrolide antibiotics), CYP3A4 inducers (phenytoin, rifampicin), and central nervous system depressants (barbituric acid derivatives, phenothiazine derivatives) Patients taking lemborexant, ramelteon Patients who already have impaired consciousness Patients with serious physical illness Patients with a history of hypersensitivity to the components of lemborexant or ramelteon Others: patients judged to be inappropriate by the principal investigator or coordinator

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative delirium	—

Secondary

Measure	Time frame
(1) Severity of delirium: DRS-R-98 (Trzepacz PT 1998) (2) Length of hospital stay (3) Sleep parameters 3-1. Time to sleep onset (TSO) and sleep onset time 3-2. Number of awakenings 3-3. Waking up too early 3-4. Total sleep time (TST) (4) Incidence of at least one adverse event (5) Incidence of individual adverse events (6) Incidence of serious adverse events (7) Death (8) Incidence of benzodiazepine withdrawal syndrome (9) All-cause discontinuation rate (10) Discontinuation rate due to adverse events	—

Measure

Time frame

(1) Severity of delirium: DRS-R-98 (Trzepacz PT 1998) (2) Length of hospital stay (3) Sleep parameters 3-1. Time to sleep onset (TSO) and sleep onset time 3-2. Number of awakenings 3-3. Waking up too early 3-4. Total sleep time (TST) (4) Incidence of at least one adverse event (5) Incidence of individual adverse events (6) Incidence of serious adverse events (7) Death (8) Incidence of benzodiazepine withdrawal syndrome (9) All-cause discontinuation rate (10) Discontinuation rate due to adverse events

—

Countries

Japan

Contacts

Public ContactKenji Sakuma

Fujita Health University School of Medicine Department of Psychiatry

sakuma44@fujita-hu.ac.jp0562-93-9250

Outcome results

None listed

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