Suvorexant for Insomnia

Overseen By Sarah Marrison, MD PhD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Medical University of South Carolina

Must be taking: Estrogen modulators, Aromatase inhibitors

Must not be taking: Steroids, CYP3A inhibitors, Opioids

Disqualifiers: Severe depression, Anxiety, Sleep apnea, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Suvorexant, a medication for insomnia, can aid breast cancer survivors with sleep difficulties. The goal is to determine if it improves sleep and overall quality of life for those taking medications like estrogen modulators or aromatase inhibitors. Participants will either take Suvorexant or a placebo (a pill with no active medicine) while also learning about good sleep habits. The trial seeks postmenopausal breast cancer survivors currently using these medications and experiencing insomnia. As a Phase 4 trial, Suvorexant is already FDA-approved and proven effective, and this research aims to understand how it benefits 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, but you cannot participate if you are using steroids, certain strong medications that affect liver enzymes, or other insomnia treatments.

What is the safety track record for Suvorexant?

Research has shown that suvorexant is generally safe for people. Previous studies found it to be well-tolerated, with drowsiness as the most common side effect. In clinical trials, no side effect led 1% or more of participants to stop taking the drug. This indicates that while some side effects might occur, they are not common enough to cause most people to discontinue treatment. The FDA has approved suvorexant for treating insomnia, further supporting its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Suvorexant is unique because it works by targeting the orexin system, a different mechanism compared to most standard insomnia treatments, which often involve benzodiazepines or non-benzodiazepine sleep aids that enhance GABA activity. This distinct approach helps regulate the sleep-wake cycle without the same risk of dependency associated with some traditional sleep medications. Researchers are excited about suvorexant because it offers a promising alternative that could potentially improve sleep quality with a lower likelihood of side effects like next-day drowsiness.

What evidence suggests that Suvorexant might be an effective treatment for insomnia in breast cancer survivors?

Research has shown that Suvorexant effectively treats insomnia. Studies have found that taking 20 mg of Suvorexant significantly helps people stay asleep better than a placebo. Users report better sleep quality and longer sleep duration. One study showed that it reduced the time people spent awake after initially falling asleep, allowing them to stay asleep more easily. Additionally, combined study results demonstrated that Suvorexant improved both falling asleep and staying asleep over three months of nightly use. Suvorexant has proven effective for insomnia, making it a promising option for those with sleep problems. Participants in this trial will receive either Suvorexant or a placebo, along with information on sleep hygiene, to further evaluate its effectiveness. ^{4 5 6 7 8}

Who Is on the Research Team?

Sarah Marrison, MD PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adult postmenopausal women who survived breast cancer, are currently on certain hormone therapies, and suffer from insomnia. They should be less than 5 years from diagnosis and finished with main cancer treatments for at least 6 weeks.

Inclusion Criteria

I am currently taking medication for hormone therapy.

I was diagnosed with my condition less than 5 years ago.

It has been over 6 weeks since I finished my main breast cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Suvorexant or placebo for insomnia treatment, with a dose increase after 7 days

4 weeks

3 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 study tests if Suvorexant tablets can help improve sleep in breast cancer survivors with insomnia compared to a placebo (a pill without active medication). Participants will also receive tips on good sleep habits.

How Is the Trial Designed?

Group I: Suvorexant with information on sleep hygiene Experimental Treatment 1 Intervention

Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.

Group II: Placebo with information on sleep hygiene Placebo Group 1 Intervention

Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.

Suvorexant is already approved in United States, Japan for the following indications:

Approved in United States as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Approved in Japan as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

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

Suvorexant is the first orexin receptor antagonist approved for treating insomnia, showing significant efficacy in reducing sleep latency and improving sleep maintenance in both non-elderly and elderly patients, based on two Phase 3 clinical trials with a total duration of 3 months.

The most common side effect was somnolence, with a number needed to harm (NNH) of 13 for higher doses, indicating that while suvorexant is effective, it does carry some risk of next-day sedation, leading to a recommended dose range of 10-20 mg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant for insomnia: a systematic review of the efficacy and safety profile for this newly approved hypnotic - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Citrome, L.[2018]

Suvorexant, a dual orexin receptor antagonist approved for insomnia, is primarily metabolized in the body with 90% of its radioactivity recovered after administration, indicating effective absorption and elimination.

The drug mainly inhibits CYP3A4 and CYP2C19 enzymes but is unlikely to cause significant drug interactions at clinical doses due to low plasma concentrations, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro and in vivo characterisation of the metabolism and disposition of suvorexant in humans. Cui, D., Cabalu, T., Yee, KL., et al.[2017]

Suvorexant, an orexin receptor antagonist, significantly improved sleep parameters in healthy young men, with all doses (10 mg, 50 mg, and 100 mg) showing better sleep compared to placebo, particularly in reducing the time to persistent sleep and wake after sleep onset.

While suvorexant was generally well tolerated, higher doses (50 mg and 100 mg) showed some next-day residual effects, such as reduced alertness and slower reaction times, indicating a need for careful dosing in potential therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men. Sun, H., Kennedy, WP., Wilbraham, D., et al.[2022]

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, the first orexin receptor antagonist approved by the FDA for treating insomnia, has been shown to effectively induce and maintain sleep in adult and elderly patients over treatment periods of up to 12 months.

While the FDA approved doses of 5, 10, 15, and 20 mg due to concerns about safety and next-morning effects like somnolence and unusual behaviors, suvorexant represents a novel approach to insomnia treatment, potentially leading to new therapies targeting orexin receptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant for the treatment of insomnia. Jacobson, LH., Callander, GE., Hoyer, D.[2015]

Suvorexant, a new medication for insomnia, is generally considered safe and well tolerated in most patients.

However, there is a rare but significant adverse effect associated with suvorexant in patients with Parkinson's disease, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant-Induced Dream Enactment Behavior in Parkinson Disease: A Case Report. Tabata, H., Kuriyama, A., Yamao, F., et al.[2018]

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]

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]

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]

Suvorexant, an orexin receptor antagonist, was generally well tolerated in a Phase 1 trial with 40 healthy men over 14 days, supporting its safety for use in treating insomnia.

The trial showed that higher doses (40 mg and above) resulted in 100% of subjects reporting adverse events, with common side effects including somnolence, fatigue, and headache, indicating a dose-dependent increase in side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Pharmacokinetics of Suvorexant: A Randomized Rising-Dose Trial in Healthy Men. Yee, KL., McCrea, J., Panebianco, D., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4591519/

Suvorexant in insomnia: efficacy, safety and place in therapy Similarly, suvorexant 20/15 mg was more effective than placebo in improving sleep maintenance, measured by sTST and WASO, at months 1 and 3 (p < 0.001). Changes ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02750306

NCT02750306 | Safety and Efficacy of Suvorexant (MK- ... The primary hypothesis for the study is that suvorexant is superior to placebo in improving insomnia as measured by change from baseline in polysomnography (PSG)- ...

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 exhibits a consistent lower outcome compared to placebo, with a MD of −27.9228 (95% CI: −30.3289 – −25.5167) under the common effect model. In ...

4. nature.com nature.com/articles/s41398-025-03439-8

a systematic review and network meta-analysis Therefore, any DORAs may be expected to improve overall sleep quality when administered in doses appropriate for each individual with insomnia.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6116

Suvorexant in Patients with Insomnia: Pooled Analyses of ... Study Impact: The results of the pooled analysis showed that suvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/suvorexant-oral-route/description/drg-20113017

Suvorexant (oral route) - Side effects & dosage Suvorexant is used to treat insomnia (trouble sleeping). It belongs to the ... Safety and efficacy have not been established. Geriatric. Appropriate ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/204569s006lbl.pdf

Belsomra - accessdata.fda.gov No individual adverse reaction led to discontinuation at an incidence ≥1%. Most Common Adverse Reactions. In clinical trials of patients with insomnia treated ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf

FULL PRESCRIBING INFORMATION Reference ID: 3610408 No individual adverse reaction led to discontinuation at an incidence ≥1%. Most Common Adverse Reactions. In clinical trials of patients with insomnia treated ...