Drugs / Suvorexant
Suvorexant
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed insomnia 3 milestones | |||||
| Filed | US (FDA) | — | insomnia | 2014-04-29 | “The FDA accepted the resubmission of a New Drug Application for suvorexant for insomnia in April.” merck.com ↗ |
| Rejected (CRL) | US (FDA) | — | insomnia | 2013-07-01 | “In the Complete Response Letter, the FDA advised Merck that: the efficacy of suvorexant has been established” merck.com ↗ |
| Filed | Japan (PMDA) | — | insomnia | 2013-02-01 | “Also, the company submitted an NDA for suvorexant to the health authorities in Japan;” merck.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | BELSOMRA | — | 2020-01-29 | fda.gov ↗ |
| Approved | US (FDA) | BELSOMRA | — | 2014-08-13 | fda.gov ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06326684 | Jun 2024 → Mar 2027 expected | alcohol-related disorders | William Stoops | Recruiting | No outcome recorded |
| Phase 0 | NCT05829655 | Aug 2023 → Jan 2028 expected | opiate dependence | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 0 | NCT05656534 | Nov 2022 → Aug 2024 | alcohol-related disorders | Ohio State University | Completed | Mixed |
| Phase 0 | NCT03937986 | Jul 2019 → Apr 2022 | substance-related disorder | William Stoops | Completed | No outcome recorded |
| Phase 18 trials · 1 missed | ||||||
| Phase 1 | NCT05106153 | Dec 2021 → May 2023 | substance abuse | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03999099 | Sep 2019 → Jul 2023 | nicotine dependence | Mclean Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03158025 | Apr 2017 → Jul 2018 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01311882 | Apr → Nov 2011 | insomnia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01293006 | Mar 2011 → Jan 2012 | insomnia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01300455 | Mar → Aug 2011 | obstructive sleep apnea syndrome | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 1 | NCT01059851 | May → Jul 2010 | insomnia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01043926 | Feb → Apr 2010 | insomnia, liver disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 213 trials · 1 met primary | ||||||
| Phase 2 | NCT07214207 | Dec 2025 → Sep 2030 expected | alcohol-related disorders | Ohio State University | Recruiting | No outcome recorded |
| Phase 2 | NCT06854224 | Sep 2025 → Jul 2027 expected | major depressive disorder | Marianne Goodman | Recruiting | No outcome recorded |
| Phase 2 | NCT06444256 | Jul 2024 → Jan 2027 expected | substance-related disorder | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 2 | NCT05908526 | Oct 2023 → Aug 2024 | insomnia | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 2 | NCT05546554 | Aug 2023 → Feb 2028 expected | autism | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT05711862 | Mar 2023 → Mar 2024 | methamphetamine dependence | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04629547 | May 2022 → May 2028 expected | Alzheimer disease | University of Minnesota | Recruiting | No outcome recorded |
| Phase 2 | NCT05145764 | Mar 2022 → Aug 2026 overdue | opiate dependence | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT04234997 | Aug 2021 → Aug 2024 | — | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT04262193 | Feb 2021 → Jul 2024 | opiate dependence | Wayne State University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03755310 | Feb 2019 → Mar 2020 | restless legs syndrome | Diego García-Borreguero, MD, PhD | Unknown | No outcome recorded |
| Phase 2 | NCT02785406 | May 2016 → Nov 2018 | anxiety, substance-related disorder | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT00792298 | Nov 2008 → Dec 2009 | insomnia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03412591 | Jul 2019 → Jan 2023 | adrenal gland hyperfunction, sleep disorder | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT06655883 | Oct 2025 → Jun 2027 expected | insomnia | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT04571944 | Oct 2020 → Dec 2022 | delirium | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT02750306 | May 2016 → Sep 2018 | Alzheimer disease, sleep disorder, initiating and maintaining sleep | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01097616 | May 2010 → Sep 2011 | insomnia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01097629 | May 2010 → Nov 2011 | insomnia | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT01021813 | Dec 2009 → May 2011 | insomnia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 420 trials · 4 met primary · 1 missed | ||||||
| Phase 4 | NCT06788522 | Jun 2026 → Mar 2032 expected | insomnia, post-traumatic stress disorder | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06584942 | Mar 2025 → Jun 2026 | cannabis dependence | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06834386 | Feb → Apr 2025 | cancer, delirium, hematopoietic and lymphoid system neoplasm, insomnia | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06162663 | Sep 2024 → Feb 2026 | breast cancer, insomnia | Medical University of South Carolina | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05823844 | May 2023 → May 2025 overdue | delirium | Columbia University | Recruiting | No outcome recorded |
| Phase 4 | NCT05593653 | Jan 2023 → Oct 2025 | abdominal obesity-metabolic syndrome, insomnia | Brigham and Women's Hospital | Completed | Met primary |
| Phase 4 | NCT04706091 | Aug 2021 → Oct 2023 | insomnia, restless legs syndrome | Massachusetts General Hospital | Completed | Missed primary |
| Phase 4 | NCT03642028 | Aug 2019 → Dec 2025 overdue | post-traumatic stress disorder, sleep disorder, initiating and maintaining sleep | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 4 | NCT03768713 | Apr 2019 → Dec 2022 | insomnia | Montana State University | Unknown | No outcome recorded |
| Phase 4 | NCT03764683 | Feb 2019 → Jan 2021 | bipolar disorder, insomnia | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT03034018 | May 2017 → Apr 2020 | insomnia | Brigham and Women's Hospital | Completed | Met primary |
| Phase 4 | NCT03110315 | Mar 2017 → Mar 2022 | insomnia, multiple sclerosis | Theodore R. Brown, MD MPH | Completed | No outcome recorded |
| Phase 4 | NCT02669030 | Mar 2017 → Dec 2019 | insomnia, major depressive disorder | Institute for Advanced Medical Research, Alpharetta, GA | Unknown | No outcome recorded |
| Phase 4 | NCT02849184 | Jan → Oct 2017 | hypertensive disorder, insomnia | Jichi Medical University | Completed | No outcome recorded |
| Phase 4 | NCT02849548 | Jan 2017 → May 2021 | post-traumatic stress disorder | Howard University | Completed | No outcome recorded |
| Phase 4 | NCT02704754 | May 2016 → Apr 2021 | insomnia, post-traumatic stress disorder | Howard University | Completed | No outcome recorded |
| Phase 4 | NCT02593682 | May 2016 → Mar 2020 | panic disorder | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT02491788 | Feb 2016 → Aug 2019 | circadian rhythm sleep disorder, shift work type | VA Palo Alto Health Care System | Completed | Met primary |
| Phase 4 | NCT02684136 | Feb 2016 → Jul 2018 | fibromyalgia, insomnia | Henry Ford Health System | Terminated | Met primary Stop: Enrollment |
| Phase 4 | NCT02527564 | Sep 2015 → Mar 2021 | bipolar disorder, insomnia | Stanford University | Completed | No outcome recorded |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT05630781 | Feb 2023 → Dec 2027 expected | nicotine dependence | National Institute on Drug Abuse (NIDA) | Recruiting | No outcome recorded |
| — | NCT03077620 | Nov 2016 → Mar 2021 | — | Washington University School of Medicine | Completed | Missed primary |
| Comparator or background therapy16 trials | ||||||
| Phase 0 | NCT04273776 Comparator | Dec 2019 → Nov 2024 overdue | — | Walter Reed Army Institute of Research (WRAIR) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03657355 Comparator | Sep 2018 → Aug 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT06484075 Comparator | Nov 2024 → Dec 2028 expected | alcohol-related disorders | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Recruiting | No outcome recorded |
| Phase 2 | NCT06679062 Comparator | Jul 2025 → Mar 2027 expected | alcohol-related disorders, insomnia, post-traumatic stress disorder | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | Recruiting | No outcome recorded |
| Phase 2 | NCT05733286 Comparator | Jun 2023 → Jun 2025 | delirium | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT05546515 Comparator | Dec 2022 → Nov 2024 | substance-related disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT04229095 Comparator | Nov 2021 → Nov 2022 | alcohol dependence | The Scripps Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT04287062 Comparator | Nov 2020 → Aug 2025 | opiate dependence, sleep disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT03897062 Comparator | Aug 2019 → Jul 2022 | alcohol dependence, insomnia | The Florey Institute of Neuroscience and Mental Health | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03789214 Comparator | Jul 2019 → Jun 2021 | opiate dependence, sleep disorder, substance withdrawal syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT07686731 Comparator | Sep 2026 → Mar 2029 expected | insomnia, post-traumatic stress disorder, traumatic brain injury | Northern California Institute of Research and Education | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04092894 Comparator | Feb 2020 → Feb 2025 | delirium, insomnia, sleep disorder, initiating and maintaining sleep | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT04014387 Comparator | Jun 2019 → Jun 2025 | insomnia, progressive supranuclear palsy | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT03818581 Comparator | Mar 2019 → Nov 2021 | insomnia, type 2 diabetes mellitus | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03312517 Comparator | Apr → Oct 2018 | insomnia | Henry Ford Health System | Completed | No outcome recorded |
| Phase 4 | NCT02729714 Comparator | Apr 2016 → Apr 2022 | insomnia | Burdick, Daniel, M.D. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2020-02-03 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Approval for BELSOMRA® (suvorexant) C-IV Label Update to Include Findings from Study of Insomnia in Patients with Mild-to-Moderate Alzheimer’s Disease merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for an update to the prescribing information for BELSOMRA ® (suvorexant) C-IV to include findings on its use for the treatment of insomnia in patients with mild-to-moderate Alzheimer’s disease. |
| 2019-05-07 | Merck Sharp & Dohme LLC | Results Merck’s BELSOMRA® (suvorexant) C-IV Meets Primary Efficacy Endpoint in Phase 3 Trial for the Treatment of Insomnia in People with Mild-to-Moderate Alzheimer’s Disease Dementia merck.com ↗
This is the first dedicated Phase 3 polysomnography study of an insomnia medication in people with mild-to-moderate Alzheimer’s disease dementia, and in the trial, BELSOMRA met its primary and secondary efficacy endpoints. |
| 2014-08-13 | Merck Sharp & Dohme LLC | Regulatory FDA Approves BELSOMRA® (suvorexant) for the Treatment of Insomnia merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved BELSOMRA ® (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep. |
| 2014-04-29 | Merck Sharp & Dohme LLC | Regulatory Merck Announces First-Quarter 2014 Financial Results merck.com ↗
The FDA accepted the resubmission of a New Drug Application for suvorexant for insomnia in April. |
| 2013-07-01 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Complete Response Letter for Suvorexant, Merck’s Investigational Medicine for Insomnia merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application for suvorexant, Merck’s investigational medicine for the treatment of insomnia. |
| 2013-05-22 | Merck Sharp & Dohme LLC | Regulatory Merck Statement on FDA Advisory Committee Meeting for Suvorexant merck.com ↗ |
| 2012-11-08 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acceptance of New Drug Application for Suvorexant, an Investigational Insomnia Medicine merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for suvorexant, the company’s investigational insomnia medicine, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). |
| 2012-09-10 | Merck Sharp & Dohme LLC | Results Merck Announces New Phase III Data for Suvorexant, an Investigational Insomnia Medicine merck.com ↗
We found that the patients who had been taking suvorexant for 12 months and were switched to placebo saw their insomnia return, but clinically meaningful withdrawal symptoms and rebound insomnia did not emerge. |
| 2012-06-13 | Merck Sharp & Dohme LLC | Results New Phase III Data Showed Merck’s Investigational Insomnia Medicine Suvorexant Improved Patients’ Ability to Fall Asleep and Stay Asleep merck.com ↗
In the studies, suvorexant significantly reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at the three-month time point compared to placebo. |
| 2012-02-06 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Development Program for Suvorexant, an Investigational Orexin Receptor Antagonist for the Treatment of Insomnia merck.com ↗
The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration (FDA) in 2012. |
All press releases naming this drug 11 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 73 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Suvorexant | “This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a...” NCT05630781 ↗68“The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants” NCT06444256 ↗ |
| Known as | Belsomra | “Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a dual orexin receptor...” NCT06854224 ↗5“The goal of this study is to observe the impact of suvorexant, sold as BELSOMRA, on brain activity of people who frequently use cannabis.” NCT06584942 ↗ “suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal” NCT03789214 ↗ “Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia” NCT03897062 ↗ “Suvorexant (Belsomra) is approved by the U.S. Food and Drug Administration (FDA) to treat insomnia.” NCT03764683 ↗ “Suvorexant (Belsomra®)” NCT03768713 ↗ |
| Known as | MK-4305 | “suvorexant (MK-4305)” NCT01293006 ↗ |
| Known as | SUV | “compared with placebo (PBO) and supratherapeutic doses of zolpidem (ZOL) 30 mg and suvorexant (SUV) 40 mg.” PMID 35748777 ↗ Jun 20221“Suvorexant (SUV) will be placed in opaque capsules with dextrose filler.” NCT05656534 ↗ |
| Known as | SUVO | “The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants” NCT06444256 ↗3“suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal” NCT03789214 ↗ “Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo.” NCT05546515 ↗ “suvorexant (SUVO)” NCT05711862 ↗ |
| Known as | Suvorexant component of belsomra | ChEMBL registry synonym — accepted as the source's own label CHEMBL1083659 ↗ |
| Action | Inhibit | “suvorexant, an orexin receptor antagonist” PMID 23197752 ↗ Nov 2012 |
| Modality | Small molecule | — CHEMBL1083659 ↗ |
| Route | Oral | “oral tablet taken before bedtime” NCT00792298 ↗ |