Drugs / Suvorexant
Suvorexant
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BELSOMRA | — | 2020-01-29 | fda.gov ↗ |
| Approved | US (FDA) | BELSOMRA | — | 2014-08-13 | fda.gov ↗ |
Trials 54 · a red edge is where a trial was stopped
| 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 | No outcome recorded |
| Phase 0 | NCT03937986 | Jul 2019 → Apr 2022 | substance-related disorder | William Stoops | Completed | No outcome recorded |
| Phase 18 trials | ||||||
| Phase 1 | NCT05106153 | Dec 2021 → May 2023 | substance abuse | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03999099 | Sep 2019 → Jul 2026 overdue | nicotine dependence | Mclean Hospital | Active not recruiting | 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 | No outcome recorded |
| 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 | ||||||
| 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 |
| 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 |
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT02750306 | May 2016 → Sep 2018 | Alzheimer disease, sleep disorder, initiating and maintaining sleep | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01097616 | May 2010 → Sep 2011 | insomnia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01097629 | May 2010 → Nov 2011 | insomnia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01021813 | Dec 2009 → May 2011 | insomnia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 420 trials | ||||||
| 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 |
| Phase 4 | NCT06162663 | Sep 2024 → Feb 2026 | breast cancer, insomnia | Medical University of South Carolina | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| Phase 4 | NCT04706091 | Aug 2021 → Oct 2023 | insomnia, restless legs syndrome | Massachusetts General Hospital | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | NCT02684136 | Feb 2016 → Jul 2018 | fibromyalgia, insomnia | Henry Ford Health System | Terminated | No outcome recorded |
| Phase 4 | NCT02491788 | Feb 2016 → Aug 2019 | circadian rhythm sleep disorder, shift work type | VA Palo Alto Health Care System | Completed | No outcome recorded |
| Phase 4 | NCT02527564 | Sep 2015 → Mar 2021 | bipolar disorder, insomnia | Stanford University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | 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 | No outcome recorded |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04273776 Comparator | Dec 2019 → Nov 2024 overdue | — | Walter Reed Army Institute of Research (WRAIR) | Active not recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT03657355 Comparator | Sep 2018 → Aug 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| 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 27 trials | ||||||
| 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 |
| Phase 2 | NCT03789214 Comparator | Jul 2019 → Jun 2021 | opiate dependence, sleep disorder, substance withdrawal syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| 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 | — | 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 |
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 ↗6“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) is an FDA approved, dual orexin receptor antagonist.” NCT04014387 ↗ “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 ↗ |