Suvorexant for Insomnia

Overseen By Aleta Wiley, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Must not be taking: Hypnotics, Insulin sensitizers

Disqualifiers: Diabetes, Obesity, Depression, 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: Unknown

61 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether suvorexant, a medication, can improve insomnia in women who are pre-diabetic and have trouble sleeping. Participants will take either suvorexant or a placebo (a pill with no active medicine) at bedtime for four weeks. Women in midlife who have ongoing sleep issues, experience hot flashes, and are pre-diabetic might be a good fit for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective suvorexant benefits more patients.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any sleep medications during the study. Additionally, if you are using medications that interact with suvorexant or have concerns about taking them together, you may need to stop those as well.

What is the safety track record for these treatments?

Research has shown that suvorexant is generally safe for treating insomnia and is well tolerated by many people. The most common side effect is drowsiness. One study found that serious side effects occurred in about 5% of people taking suvorexant, compared to 7% of those taking a placebo, indicating that serious issues are uncommon. Another study found that suvorexant improved sleep over three months and was safe for most people. Overall, evidence suggests that suvorexant is a safe option for addressing sleep problems. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for insomnia, which often include benzodiazepines or non-benzodiazepine hypnotics, suvorexant works by targeting the orexin system. This system is responsible for regulating wakefulness, so by blocking orexin receptors, suvorexant helps promote sleep. Researchers are excited about suvorexant because it offers a new mechanism of action, potentially reducing the risk of dependency and side effects often associated with traditional sleep medications. Additionally, its unique approach may provide a more natural sleep pattern, which is a promising development for those struggling with insomnia.

What is the effectiveness track record for suvorexant in treating insomnia?

In this trial, participants will receive either suvorexant or a placebo. Studies have shown that suvorexant helps treat insomnia. Research indicates that suvorexant can improve both the duration and quality of sleep. In one study, participants taking 20 mg of suvorexant stayed asleep longer and woke up less during the night compared to those taking a placebo. Overall, suvorexant has proven effective in helping people with insomnia achieve more restful sleep. ^{1 5 6 7 8}

Who Is on the Research Team?

Shadab Rahman, PhD MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for midlife women aged 40-65 who are pre-diabetic, experiencing insomnia and hot flashes, including at night. They should have an Insomnia Severity Index score of ≥15. Women must be postmenopausal or late perimenopausal without serious mental health issues, major organ disease, recent surgery, or use of sleep medications.

Inclusion Criteria

I am a healthy woman aged between 40 and 65.

I have been diagnosed with Insomnia Disorder.

I have been experiencing ongoing sleep problems.

Exclusion Criteria

Unwilling to limit alcohol, nicotine, and caffeine consumption during study

You have recently traveled across different time zones.

I have been diagnosed with a sleep disorder other than the one being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment Block 1

Participants take either suvorexant or placebo daily for 4 weeks

4 weeks

Includes blood draws and monitoring

Washout

Participants undergo a washout period with no treatment

4 weeks

Treatment Block 2

Participants take the alternate treatment (suvorexant or placebo) daily for 4 weeks

4 weeks

Includes blood draws and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Suvorexant

Trial Overview The study tests if Suvorexant can improve sleep in women with pre-diabetes and insomnia compared to a placebo (a pill with no active drug). Participants will not know which treatment they receive to ensure the results are unbiased.

How Is the Trial Designed?

Group I: suvorexant Experimental Treatment 1 Intervention

20mg taken at bedtime for 4 weeks

Group II: placebo Placebo Group 1 Intervention

placebo taken at bedtime for 4 weeks

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?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4990943/

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 ...

3. 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)- ...

4. 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 ...

5. 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.

6. 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 ...

7. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(14)70053-5/abstract

Safety and efficacy of suvorexant during 1-year treatment ... Serious adverse events were recorded in 27 patients (5%) who received suvorexant and 17 (7%) who received placebo. The most common adverse event ...

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

Suvorexant in Patients with Insomnia: Pooled Analyses of ... Conclusions: Suvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.