Suvorexant for Delirium Prevention in Cancer Patients

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: CYP3A4 modulators, Benzodiazepines

Disqualifiers: Pregnancy, Delirium, Narcolepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3-7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding suvorexant, a sleep aid, to standard hospital care can better prevent confusion (delirium) in cancer patients with sleep difficulties. Delirium can extend hospital stays and delay cancer treatments. The trial compares two groups: one receiving suvorexant with standard care and another receiving only standard care. Cancer patients with insomnia and risk factors such as hearing or vision problems, or prolonged hospital stays, may be suitable candidates for this study. As a Phase 4 trial, it involves an FDA-approved treatment and aims to understand how suvorexant can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using any benzodiazepines, benzodiazepine receptor modulators, or first-generation antihistamines at least 72 hours before joining. Also, you cannot use strong or moderate CYP3A4 inducers and inhibitors during the trial.

What is the safety track record for suvorexant?

Research has shown that suvorexant is generally safe for people. A review of seven studies found that suvorexant helps reduce delirium, including 402 patients who took the medication. Three studies from Japan also found that suvorexant is safe and effective for preventing delirium in hospitalized patients over a week.

In one study, 17% of patients taking suvorexant experienced delirium, compared to 26% in a placebo group. Another study in a palliative care unit found that suvorexant led to less delirium (14.3%) compared to benzodiazepines (25%).

These findings suggest that suvorexant is well-tolerated and safe for people dealing with issues like insomnia or delirium. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Suvorexant is unique because it targets the brain's orexin system, which plays a key role in wakefulness and sleep regulation. Unlike traditional sleep aids that often involve benzodiazepines or antihistamines, suvorexant works by blocking orexin receptors, helping patients fall asleep without the same risk of dependency or cognitive side effects. Researchers are excited about suvorexant for preventing delirium in cancer patients as it may offer a better-tolerated alternative to current insomnia treatments, potentially reducing delirium risk while maintaining sleep quality.

What evidence suggests that suvorexant might be an effective treatment for delirium in cancer patients?

Research has shown that suvorexant, a medication that helps people stay asleep, effectively reduces delirium in hospitalized patients. One study found that only 17% of patients who took suvorexant developed delirium, compared to 26% who took a placebo (a pill with no active medicine). Other studies from Japan have also found it effective and safe for preventing delirium over a week. Reviews of multiple studies indicate that suvorexant significantly lowers the risk of delirium, especially in patients with sleep problems. In this trial, some participants will receive suvorexant alongside standard care to assess its effectiveness in cancer patients. Specifically, for cancer patients, suvorexant has reduced the severity of delirium symptoms. Overall, strong evidence supports suvorexant's role in reducing delirium in patients with sleep issues. ^{2 3 5 6 7}

Who Is on the Research Team?

Regina M. Mackey, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for hospitalized cancer patients experiencing insomnia, which may lead to delirium. Participants should meet the study's inclusion criteria and not have any conditions that would exclude them from participating as per the trial's exclusion criteria.

Inclusion Criteria

One or more of the following risk factors of delirium: Age 75 or above, Hearing impairment, Vision impairment, Initiation of 8 or new medications since start of hospitalization, Chronic kidney disease III or greater, Congestive heart failure, Hospitalization for 14 or more days, Dehydration requiring ongoing use of intravenous (IV) hydration, Electrolyte imbalance requiring ongoing correction

Anticipated hospital course of at least 3 days post randomization as judged by the patient's primary inpatient team

I have advanced cancer and suffer from insomnia despite trying non-drug treatments.

Exclusion Criteria

I have been diagnosed with a sleep disorder like sleep apnea.

I am not taking any strong medications like certain antifungals or seizure drugs.

I have a history of lung disease, but not asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients receive suvorexant and standard of care for hospital associated insomnia for 3-7 days

3-7 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suvorexant

Trial Overview The trial compares suvorexant combined with standard care versus standard care alone in treating insomnia and preventing delirium in hospitalized cancer patients. Suvorexant is a medication that blocks brain substances causing wakefulness.

How Is the Trial Designed?

Group I: Arm I (suvorexant, standard of care) Experimental Treatment 5 Interventions

Patients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.

Group II: Arm II (standard of care) Active Control 4 Interventions

Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 1,255 ICU patients, suvorexant significantly reduced the incidence of delirium when administered at any time before delirium onset, showing an unadjusted hazard ratio of 0.16, indicating a strong protective effect.

However, when analyzing patients who received suvorexant within 72 hours of admission, the protective effect diminished and lost statistical significance after adjusting for confounding factors, suggesting that timing of administration is crucial for efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the effect of immortal time bias affects the analysis of prevention of delirium by suvorexant in critically ill patients: A retrospective cohort study. Shiotsuka, J., Uchino, S., Sasabuchi, Y., et al.[2023]

Suvorexant, administered at doses of 15 to 20 mg, effectively reduces the incidence and onset time of delirium in acutely hospitalized patients, potentially leading to shorter hospital stays.

The treatment was well tolerated, with adverse effects comparable to those of a placebo, indicating a favorable safety profile for suvorexant in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of suvorexant in the prevention of delirium during acute hospitalization: A systematic review. Adams, AD., Pepin, MJ., Brown, JN.[2021]

Suvorexant, both alone and in combination with ramelteon, significantly reduces the incidence of delirium in hospitalized adults, based on a meta-analysis of 2594 patients across various studies.

When benzodiazepines are used, the combination of suvorexant and ramelteon is particularly effective in preventing delirium, while suvorexant alone does not show significant benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant with or without ramelteon to prevent delirium: a systematic review and meta-analysis. Tian, Y., Qin, Z., Han, Y.[2022]

A meta-analysis of seven studies involving 402 patients treated with suvorexant showed a significant reduction in the incidence of delirium (odds ratio of 0.30) and a delay in the onset of delirium (standardized mean difference of 0.44) compared to control treatments.

Suvorexant did not show significant benefits on secondary outcomes such as length of hospital stay, time on ventilation, or mortality, indicating its primary effectiveness lies in preventing delirium rather than improving overall hospital metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant for the prevention of delirium: A meta-analysis. Xu, S., Cui, Y., Shen, J., et al.[2021]

In a study of nine cancer patients with delirium and insomnia, the use of suvorexant significantly reduced the severity of delirium symptoms, as measured by the DRS-R98 scale (from 10 to 6.66, p=0.0031).

Suvorexant was found to be safe, with no harmful effects reported, suggesting it could be a beneficial treatment option for managing delirium in hospitalized cancer patients experiencing sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Usefulness of Suvorexant for Complicated Delirium in Cancer Patients Who Experience Sleep Disturbance during Hospitalization]. Kessoku, T., Kusakabe, A., Matsuura, T., et al.[2019]

In a study of 70 critically ill patients in the ICU, those treated with suvorexant experienced a significantly longer time to onset of delirium compared to those receiving conventional treatment, suggesting its potential effectiveness in preventing delirium.

The study indicates that suvorexant could be a promising option for preventing delirium in ICU patients, as it was administered over a 7-day period with no significant differences in demographic or clinical characteristics between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ability of suvorexant to prevent delirium in patients in the intensive care unit: a randomized controlled trial. Azuma, K., Takaesu, Y., Soeda, H., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40511987/

Efficacy of Ramelteon, Suvorexant, and Lemborexant for ... Pooled analyses showed a significant reduction in delirium prevalence in both randomized trials (RR, 0.60; 95% CI, 0.38-0.97; low certainty) and ...

2. jclinque.com jclinque.com/article/effectiveness-and-safety-of-suvorexant-in-preventing-delirium-a-systematic-review-and-meta-analysis

Effectiveness and Safety of Suvorexant in Preventing ... Three studies from Japan suggest that Suvorexant may be an effective and safe treatment for preventing delirium in hospitalized patients over seven days.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822422

Suvorexant for Reduction of Delirium in Older Adults After ... Findings In this randomized clinical trial of 203 participants, 17% in the suvorexant-treated group had delirium vs 26% in the placebo group; ...

4. withpower.com withpower.com/trial/phase-4-neoplasms-1-2025-c865d

Suvorexant for Delirium Prevention in Cancer Patients Research shows that Suvorexant helped reduce delirium symptoms in cancer patients with sleep problems, as their delirium severity scores significantly decreased ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000208734

Efficacy of Suvorexant in the Prevention of Delirium Conclusions: This meta-analysis suggests that suvorexant was considered effective in reducing the incidence of delirium in hospitalized patients, particularly ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7386982/

Suvorexant for the prevention of delirium: A meta-analysis Seven studies which comprised 402 suvorexant treatment patients and 487 patients with control treatment were included in this meta-analysis.

7. heraldopenaccess.us heraldopenaccess.us/openaccess/efficacy-and-safety-of-suvorexant-in-a-palliative-care-unit-a-retrospective-single-center-study

Efficacy and Safety of Suvorexant in a Palliative Care Unit Suvorexant was more clinically effective (85.7% versus 50.0%), with a lower incidence of delirium (14.3% versus 25.0%), than BZDs.