Belsomra (suvorexant) / Merck (MSD) - LARVOL DELTA

Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Trial completion date: Dec 2029 ➔ Dec 2032 | Trial primary completion date: Dec 2028 ➔ Dec 2031

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Mayo Clinic | N=14 ➔ 0 | Trial completion date: May 2026 ➔ Apr 2025 | Recruiting ➔ Withdrawn | Trial primary completion date: May 2026 ➔ Apr 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • CNS Disorders • Hematological Malignancies • Insomnia • Oncology • Sleep Disorder • Solid Tumor

Study finds common sleeping pill could help prevent Alzheimer's disease - "The study examined suvorexant, a sleeping pill regularly prescribed for insomnia, and observed its effects on clearing those waste proteins. The researchers enlisted 38 middle-aged adults and split them into two groups, one with the sleeping pill and one with a placebo. The authors observed a 10 to 20 percent decrease in the waste proteins in those who took the sleeping pill over those who didn't...Although the results certainly indicate that the medicine could in some way prevent Alzheimer's, the researchers noted that the results were very short-lived and that regularly taking the medication came with a slew of other side effects."

Clinical data • Alzheimer's Disease • Sleep Disorder

Treatment Patterns for Sleep Disorders in the United States Veterans Affairs Healthcare System (ISPOR 2025) - "Other treatments may include the melatonin receptor agonist (ramelteon) or sedating antidepressants (trazodone, off label)...Overall, an estimated 2.6% were prescribed zolpidem, 0.7% temazepam, 0.28% eszopiclone, 0.12% ramelteon, 0.06% zaleplon, 0.05% suvorexant, 0.04% triazolam, 0.006% lemborexant, 0.005% estazolam, and 0.001% daridorexant... The Z-drug zolpidem was the most commonly prescribed medication indicated for insomnia. Sedative antidepressants were also frequently utilized, likely due to their affordability and the lack of widely accepted, cost-effective alternatives for managing insomnia. Lemborexant and daridorexant, more recently approved for insomnia, were prescribed less frequently and have not yet become mainstream frontline treatments."

CNS Disorders • Insomnia • Sleep Disorder

Quantification of daridorexant, lemborexant and suvorexant in whole blood using liquid chromatography-tandem mass spectrometry. (PubMed, J Anal Toxicol) - "A proof-of-concept study using authentic blood samples containing suvorexant, compared to previously reported concentrations, showed no consistent decrease over time, highlighting the need for further studies to determine optimal storage conditions for long-term stability. Although further studies are needed with authentic samples containing the more novel DORAs lemborexant or daridorexant, this validated method supports broader adoption in forensic toxicology, enhancing the detection and monitoring of these emerging sedative-hypnotics in forensic investigations."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Dual Hypocretin Receptor Antagonism Reduces Oxycodone Seeking During Abstinence. (PubMed, bioRxiv) - "Treatment with suvorexant 24 h prior to a cue-induced seeking test significantly reduced oxycodone seeking and normalized aberrant dopamine uptake. These findings suggest that targeting hypocretin receptors may be a promising strategy for reducing opioid craving and associated neuroadaptations, thus lowering the risk of relapse."

Journal • Substance Abuse

Efficacy of Suvorexant in the Prevention of Delirium: A Systematic Review and Meta-analysis (S17.010). (PubMed, Neurology) - "Moreover, its association with Ramelteon, a melatonin receptor agonist, has shown even more promising results. Germano Hennemann has nothing to disclose. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff."

Clinical • Journal • Retrospective data • Review • CNS Disorders

A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Walter Reed Army Institute of Research (WRAIR) | Enrolling by invitation ➔ Active, not recruiting | Trial primary completion date: Dec 2025 ➔ Nov 2024

Enrollment closed • Trial primary completion date

The Effect of Suvorexant on Fear Extinction Recall: A Double-Blind Randomised Controlled Pilot Trial in Healthy Individuals. (PubMed, J Sleep Res) - "In this pilot, randomised controlled trial, we investigated the effect of 20 mg suvorexant to increase REM sleep, 20 mg temazepam to decrease REM sleep, and a placebo on extinction recall in 30 healthy adults (age: M = 26.93 years, SD = 7.54). These findings suggest that increasing REM sleep in populations with REM disruptions such as PTSD to optimal levels could improve extinction recall. This underscores the potential of enhancing REM sleep as a therapeutic target for improving PTSD outcomes, warranting further investigation of suvorexant in clinical populations where REM sleep deficits are prevalent."

Journal • CNS Disorders • Developmental Disorders • Mood Disorders • Post-traumatic Stress Disorder • Sleep Disorder

Protocol and design of the REPOSE study: a double-blinded, randomised, placebo-controlled trial to evaluate the efficacy of suvorexant to improve postoperative sleep and reduce delirium severity in older patients undergoing non-cardiac surgery. (PubMed, BMJ Open) - P2 | "Trial data will be deposited in ClinicalTrials.gov. NCT05733286."

Clinical • Clinical protocol • Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Insomnia • Sleep Disorder

Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients with Cannabis Use Disorder (Pilot Study) (clinicaltrials.gov) - P4 | N=10 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients (clinicaltrials.gov) - P4 | N=14 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Hematological Malignancies • Insomnia • Oncology • Sleep Disorder • Solid Tumor

Impact of Postoperative Sleep Medication Use on 90-Day Complications Following Total Knee Arthroplasty (AAOS 2025) - "We further analyzed the effects of standard prescription sleep medications (Daridorexant, Eszopiclone, Lemborexant, Suvorexant, Temazepam, Triazolam, Zaleplon, Zolpidem) and less potent prescription sleep medications (Doxepin, Ramelteon). Both standard and less potent prescription sleep medication use is associated with surgical complications. Post-operative sleep disturbance remains a major problem following TKA, but prescription sleep medications may be unsafe for routine postoperative use."

Insomnia • Musculoskeletal Diseases • Orthopedics • Pain • Sleep Disorder

A Randomized, Double-blind, Placebo-controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease (AAN 2025) - "This study is the first randomized trial of suvorexant in patients with Parkinson disease. While it did not meet its primary endpoint, several secondary outcome measures showed a trend favoring suvorexant over placebo. Larger trials in this population are warranted, but recruiting this population for a study requiring multiple overnight polysomnograms proved more difficult than expected."

Clinical • CNS Disorders • Depression • Insomnia • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder

Efficacy of Suvorexant in the Prevention of Delirium: A Systematic Review and Meta-analysis (AAN 2025) - "Moreover, its association with Ramelteon, a melatonin receptor agonist, has shown even more promising results.Design/We searched in the PubMed, Cochrane, and Embase databases for randomized controlled trials (RCTs), and observational studies that evaluated the efficacy of suvorexant in preventing delirium in hospitalized patients, particularly postoperatively. This meta-analysis suggests that suvorexant was considered effective in reducing the incidence of delirium in hospitalized patients, particularly in postoperative settings."

Retrospective data • Review • CNS Disorders

Safety of dual orexin receptor antagonists: a real-world pharmacovigilance study. (PubMed, Expert Opin Drug Saf) - "Data related to daridorexant, suvorexant, and lemborexant were collected from the US Food and Drug Administration Adverse Event Reporting System between the first quarter of 2022 and the third quarter of 2024. The analysis of disproportionality signals may prompt increased awareness of toxicities for DORAs. The results of serious reports and dosage of drugs provided supporting evidence for clinicians to manage AEs."

Adverse events • Journal • Real-world evidence • CNS Disorders • Insomnia • Sleep Disorder

Efficacy and Safety Profile of Suvorexant for the Treatment of Insomnia. (PubMed, Curr Drug Saf) - "Some common adverse effects of suvorexant are headache, somnolence, dizziness, diarrhea, cough, abnormal dreams, and upper respiratory tract infection. The current paper aimed to review the pharmacokinetics and pharmacodynamic properties of suvorexant."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Cough • Infectious Disease • Insomnia • Pain • Respiratory Diseases • Sleep Disorder

Orexin Antagonism for Suicide Risk: a Proof-of-Concept Clinical Trial (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Marianne Goodman

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Green stability-indicating RP-HPTLC approach for determining suvorexant in commercial tablet dosage forms. (PubMed, BMC Chem) - "It was observed that marketed SUV tablet brands A and B contained, respectively, 98.18 and 101.32% of SUV. The findings of the study indicated that SUV in marketed tablet dosage forms may be monitored on a regular basis with the use of the current green HPTLC methodology."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Opioid-induced neuroanatomical, microglial and behavioral changes are blocked by suvorexant without diminishing opioid analgesia. (PubMed, Nat Ment Health) - "However, suvorexant does not diminish morphine analgesia. Here we show that combined administration of opioids and suvorexant may reduce the addiction potential of opioid use for pain relief in humans while maintaining the analgesic effects of opioids."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Pain • Psychiatry

Cochlear Expression of Orexin Signaling Molecules and Their Role in Hearing (ARO 2025) - "The Ox receptor antagonist Suvorexant (Belsomra®) represents one such drug... Deficiency in Ox signaling may lead to greater incidence of permanent threshold shifts following exposures to even moderate intensity noise that induce only TTS in WT mice. Whether NIHL is exacerbated by Ox receptor antagonist drug use remains to be fully determined. However, given that most people using such drugs are also older and likely also suffering from age-related hearing loss, this question takes on greater significance."

CNS Disorders • Insomnia • Narcolepsy • Otorhinolaryngology • Sleep Disorder • AQP1

Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients (clinicaltrials.gov) - P4 | N=14 | Not yet recruiting | Sponsor: Mayo Clinic

New P4 trial • CNS Disorders • Hematological Malignancies • Insomnia • Oncology • Sleep Disorder • Solid Tumor

Stability assessment of hygroscopic medications in one dose packaging using community pharmacist surveys and experimental storage methods. (PubMed, Sci Rep) - "Suvorexant, Telmisartan, Aspirin Dialuminate, Kampo extract formulations (Yokukansan and Daikenchu-tou), and Yokuinin extract tablets were selected for the stability test. However, further research is necessary to justify the decision not to include hygroscopic pharmaceuticals in such packaging. Therefore, pharmaceutical companies should cultivate appropriate awareness and information literacy of pharmacists should be improved."

Journal

Risk of falls associated with non-GABAergic hypnotics and benzodiazepines in hospitalized patients. (PubMed, Gen Hosp Psychiatry) - "In hospitalized patients at general hospitals, ramelteon and suvorexant may not increase the risk of falls, while the use of benzodiazepines and trazodone requires careful attention to minimize this risk."

Journal

Trial of Suvorexant for Sleep in Children with Autism (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: Stanford University | Trial completion date: Feb 2027 ➔ Feb 2028 | Trial primary completion date: Feb 2027 ➔ Feb 2028

Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders