Suvorexant for Sleep Disorders in ICU Patients

No longer recruiting at 2 trial locations

Overseen By Omid Azimaraghi

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Benzodiazepines, Antidepressants

Disqualifiers: Renal failure, Liver failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a drug called suvorexant can improve sleep for heart surgery patients in the ICU. Researchers seek to find out if suvorexant reduces nighttime wakefulness and enhances overall sleep quality compared to a placebo. Participants must be 60 or older, have undergone coronary artery bypass surgery, and have been moved to the ICU. As a Phase 4 trial, this research explores how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using chronic benzodiazepines or medications for cognitive decline, you may not be eligible to participate.

What is the safety track record for suvorexant?

Research has shown that suvorexant is generally safe for people. A study lasting up to 14 months found that participants tolerated suvorexant well, with no major side effects reported. It is already approved for treating insomnia, indicating it has passed safety checks for this use. Some studies suggest it might also help prevent delirium, a serious state of confusion, in patients. Overall, suvorexant is considered to have a good safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard sleep medications for ICU patients, which often include benzodiazepines or sedatives that can have significant side effects, Suvorexant offers a unique approach by targeting orexin receptors in the brain. This mechanism helps regulate wakefulness and sleep, potentially leading to better sleep quality without the sedation hangover or dependency risks commonly associated with other treatments. Researchers are excited about Suvorexant's potential to improve sleep in ICU patients while minimizing adverse effects, making it a promising option for enhancing recovery and overall patient care.

What evidence suggests that suvorexant might be an effective treatment for sleep disorders in ICU patients?

This trial will compare Suvorexant with a placebo to assess its effectiveness in improving sleep for ICU patients. Studies have shown that Suvorexant helps people sleep better by enabling them to fall asleep faster and stay asleep longer. Previous research demonstrated that Suvorexant outperformed a placebo in reducing nighttime awakenings and enhancing overall sleep quality. Generally well-tolerated and currently approved as a sleep aid, Suvorexant presents a promising option for improving sleep in ICU patients who often struggle with sleep disturbances. ^{1 3 6 7 8}

Who Is on the Research Team?

Matthias Eikermann, MD, PHD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Balachundhar Subramaniam, M.D.

Principal Investigator

Beths Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 60 who are recovering from coronary artery bypass graft surgery in the ICU. They must speak English and not have severe obesity, known pregnancy, significant heart or kidney failure, liver failure, coma, delirium at enrollment time, certain cognitive impairments or psychiatric conditions.

Inclusion Criteria

I am 60 years old or older.

I am scheduled for heart bypass or valve surgery and will be in the ICU afterwards.

Exclusion Criteria

Your heart is not pumping blood well before surgery.

You have certain psychiatric or neurological conditions, such as bipolar disorder, chronic use of benzodiazepines, or recent seizures.

English language limitations (Sleep assessment and delirium assessment tools are only validated in English)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 days

Daily assessments

Preoperative Assessment

Participants complete the Richards-Campbell Sleep Questionnaire (RCSQ) every morning

3 days

Daily assessments

Treatment

Participants receive either suvorexant or placebo for 7 nights starting the night after extubation

7 days

Daily administration

Follow-up

Participants are monitored for postoperative delirium and sleep quality until hospital discharge

Up to 21 days

Daily assessments

What Are the Treatments Tested in This Trial?

Interventions

• Placebo oral tablet
• Suvorexant

Trial Overview The study tests if suvorexant can improve sleep after surgery by reducing wakefulness during the night. Participants will receive either suvorexant or a placebo for seven nights post-extubation. Sleep quality will be monitored using EEG technology to measure various sleep parameters.

How Is the Trial Designed?

Group I: Suvorexant Active Control 1 Intervention

Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.

Group II: Placebo Placebo Group 1 Intervention

Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

A reliable liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed to measure suvorexant levels in human plasma, demonstrating high precision and accuracy across a wide concentration range (1-1000 ng/mL).

The method has been validated for stability and can support clinical studies for suvorexant, showing that plasma samples remain stable for up to 25 months at -20°C, which is crucial for long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of suvorexant in human plasma using 96-well liquid-liquid extraction and HPLC with tandem mass spectrometric detection. Breidinger, SA., Simpson, RC., Mangin, E., et al.[2019]

Suvorexant, an orexin receptor antagonist, was found to be generally safe and well tolerated over a 1-year treatment period for patients with primary insomnia, with a notable incidence of somnolence as a common side effect.

In the first month of treatment, suvorexant significantly improved subjective total sleep time by an average of 38.7 minutes and reduced time to sleep onset by 18.0 minutes compared to placebo, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Michelson, D., Snyder, E., Paradis, E., et al.[2022]

This trial will assess the efficacy of suvorexant, an FDA-approved sleep aid, in reducing nighttime wakefulness and delirium in 120 older cardiac surgery patients in the ICU.

The study aims to determine if suvorexant can improve sleep quality and reduce the incidence of postoperative delirium, which is important for recovery in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial evaluating the effects of the orexin receptor antagonist suvorexant on sleep architecture and delirium in the intensive care unit. Azimaraghi, O., Hammer, M., Santer, P., et al.[2021]

In a study involving 12 healthy adults, suvorexant doses of 40 mg and 150 mg did not significantly affect oxygen saturation levels during sleep, indicating it does not impair respiratory function.

Suvorexant was well tolerated with no serious adverse effects reported, suggesting it is safe for use even at doses higher than the maximum recommended dose for treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the orexin receptor antagonist suvorexant on respiration during sleep in healthy subjects. Uemura, N., McCrea, J., Sun, H., et al.[2015]

Suvorexant is a first-in-class medication that works by blocking orexin receptors, which are involved in regulating wakefulness, thereby promoting sleep for individuals with insomnia.

Approved in the US in August 2014, suvorexant is effective for both sleep onset and sleep maintenance insomnia, and is in the process of being registered in other countries, indicating its potential global impact on treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant: first global approval. Yang, LP.[2021]

Suvorexant (Belsomra®) is a new sleep medication that works by blocking orexin neurons, leading to a rapid onset of sleep, and is effective at a prescribed dose of 10 mg before bedtime.

A highly sensitive urine assay was developed to accurately identify and quantify suvorexant, demonstrating excellent precision and stability, which is crucial for monitoring its use due to potential misuse and interactions with other sedatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Suvorexant in Urine Using Liquid Chromatography-Quadrupole/Time-of-Flight Mass Spectrometry (LC-Q/TOF-MS). Sullinger, S., Bryand, K., Kerrigan, S.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7371384/

Study protocol for a randomised controlled trial evaluating the ... This trial will evaluate the efficacy of postoperative oral suvorexant treatment on night-time wakefulness after persistent sleep onset as well as the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01097616

NCT01097616 | Safety and Efficacy Study of Suvorexant in ... This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from ...

3. journals.lww.com journals.lww.com/atmr/fulltext/2024/07000/the_effectiveness_of_suvorexant_compared_to_a.46.aspx

The Effectiveness of Suvorexant Compared to a Placebo in ... Suvorexant is an effective treatment for primary insomnia and is generally well-tolerated. It surpasses placebo in enhancing sleep outcomes.

4. withpower.com withpower.com/trial/phase-4-sleep-deprivation-1-2020-1c40e?condition=&query=Suvorexant&overallStatus=Recruiting&hasNoPlacebo=false

Suvorexant for Sleep Disorders in ICU Patients This trial will assess the efficacy of suvorexant, an FDA-approved sleep aid, in reducing nighttime wakefulness and delirium in 120 older cardiac surgery ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8896749/

Suvorexant in the Treatment of Difficulty Falling and Staying ... In primary insomnia, suvorexant is effective (over placebo), as measured by polysomnography and reported by patients, in both attaining and maintaining sleep.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01021813

A Long Term Safety Study of Suvorexant in Participants ... This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/3/e091099.full.pdf

a double- blinded, randomised, placebo- controlled trial to ... Postoperative sleep disturbances may increase the risk of delirium, but studies investigating pharmacotherapies to improve postoperative sleep ...

8. journals.lww.com journals.lww.com/md-journal/fulltext/2020/07240/suvorexant_for_the_prevention_of_delirium__a.22.aspx

Suvorexant for the prevention of delirium: A meta-analysis Suvorexant, an approved agent for the treatment of insomnia, is recently suggested to be also effective for prevention of delirium by some authors.