eszopiclone / Generic mfg. - LARVOL DELTA

Comparative pharmacovigilance of non-benzodiazepine receptor agonists versus dual orexin receptor antagonists for insomnia in older adults. (PubMed, Front Pharmacol) - "nBZRAs, particularly eszopiclone, showed the strongest signals related to therapeutic failure (e.g., "Drug ineffective," "Insomnia") alongside a unique signal for "Dysgeusia"...System Organ Class analysis showed that psychiatric and nervous system disorders had the highest incidence. These findings highlight distinct safety profiles: nBZRAs are linked to therapeutic failure and dysgeusia, while DORAs are associated with neuropsychiatric events such as nightmares and hallucinations."

Adverse events • Journal • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

Z-Drug Use and All-Cause Mortality: A Meta-Analysis of Observational Cohort Studies. (PubMed, Neuropsychiatr Dis Treat) - "Non-benzodiazepine hypnotic drugs known as z-drugs (including zolpidem, eszopiclone, zopiclone, zaleplon) are commonly prescribed for insomnia patients worldwide. This meta-analysis showed a positive association between z-drug use and all-cause mortality; however, the substantial between-study heterogeneity (I2 = 99.6%) warrants cautious interpretation of these findings. Clinicians should exercise caution when prescribing z-drugs to high-risk patients."

Journal • Observational data • Retrospective data • CNS Disorders • Insomnia • Sleep Disorder

Treatment Options for Sleep Disturbances in Dementia: A Systematic Review. (PubMed, J Geriatr Psychiatry Neurol) - "Z-drug eszopiclone, low-dose ORA lemborexant, and social stimulation PARO show the most favorable profile across outcomes and benchmarks, but pharmacological options require careful risk-benefit consideration. No external funding. The review was registered in INPLASY: https://doi.org/10.37766/inplasy2025.1.0097."

Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • Sleep Disorder

Evidence-based pharmacological interventions for insomnia: a systematic review on the effects of eszopiclone on insomnia comorbid with mental disturbances. (PubMed, World J Biol Psychiatry) - "According to the systematic search, 12 articles were identified investigating the use of eszopiclone in psychiatric disorders, including major depression, anxiety and related disorders, as well as schizophrenia. Overall data indicated that the use of eszopiclone as an adjunctive treatment for insomnia may alleviates insomnia symptoms and also positively influences depressive, anxiety, and cognitive aspects related to psychiatric disorders."

Journal • Review • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia • Sleep Disorder

Benzodiazepines Prescribed to Hospitalized Patients with Major Depressive Disorder: A 3-year Retrospective Observational Study. (PubMed, Neuropsychiatr Dis Treat) - "For non-selective benzodiazepines at baseline, the most commonly prescribed were lorazepam (39.6%, n=110), oxazepam (23.7%, n=66), and clonazepam (16.2%, n=45)...However, the use of clonazepam, estazolam, and alprazolam remained comparable (P > 0.05)...While its use varied significantly over time (P 0.05)...It is advisable to limit benzodiazepine prescriptions for MDD patients to within 12 months. Discontinuing benzodiazepines becomes more challenging after prolonged use beyond this period."

Journal • Observational data • Retrospective data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Eco-conscious and cost-effective electrochemical sensor for selective determination of eszopiclone in pure form, alkaline-stressed samples, and pharmaceutical tablets. (PubMed, RSC Adv) - "The method was rigorously validated as per ICH guidelines and its environmental sustainability was quantitatively assessed using the Analytical Eco-Scale and the Green Analytical Procedure Index (GAPI). Furthermore, the method's overall "whiteness" was assessed using the recently released Red-Green-Blue (RGB) 12 model approach, reflecting the balance between analytical performance, environmental impact, and practical applicability."

HEOR • Journal

Evaluation of the stability and cross-reactivity of zopiclone and eszopiclone using immunoassay kits. (PubMed, J Toxicol Sci) - "Spiked urine samples were used to confirm cross-reactivity for the immunoassay test and to compare the quantitative results of the clinical urine samples. The results indicate that urine samples stored for an extended period or altered postmortem may lead to false-negative results for ZOP, providing important information for interpreting results in cases involving ZOP."

Journal

Comparative effects of hypnotic agents on sleep architecture and respiratory outcomes in obstructive sleep apnea: A systematic review and network meta-analysis. (PubMed, Psychiatry Clin Neurosci) - "Our network meta-analysis identified different effects of various hypnotics on sleep architecture and respiratory parameters; however, the lack of data prevented a formal synthesis of subjective outcomes. Therefore, these results should be interpreted with caution in clinical practice."

Journal • Retrospective data • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

The Impact of Preoperative Administration of Esketamine Combined with Dexmedetomidine Hydrochloride Nasal Spray on Early Postoperative Recovery Quality in Endoscopic Sinus Surgery (ChiCTR) - P=N/A | N=160 | Not yet recruiting | Sponsor: Shandong Second Provincial General Hospital, Shandong Provincial ENT Hospital; Shandong Second Provincial General Hospital, Shandong Provincial ENT Ho

New trial • Otorhinolaryngology

The application of procedural sedation in precise diagnosis and treatment of congenital heart disease in children by transthoracic echocardiography (ChiCTR) - P=N/A | N=60 | Not yet recruiting | Sponsor: Yan'An hospital of Kunming City; Yan'An hospital of Kunming City

New trial • Anesthesia • Cardiovascular • Heart Failure

CALM-OSA: Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea (clinicaltrials.gov) - P3 | N=250 | Not yet recruiting | Sponsor: Yale University

New P3 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Suicide adverse events associated with zopiclone and eszopiclone: A pharmacovigilance analysis based on FAERS, JADER and CVARD. (PubMed, PLoS One) - "These findings align with published reports and clinical observations, highlighting the need for further clinical trials to investigate suicide associated with zopiclone and eszopiclone."

Adverse events • Journal • Psychiatry • Suicidal Ideation

Evaluating the Safety of Prescription Sleep Medications in Patients Undergoing Total Knee Arthroplasty: A Propensity Matched Analysis. (PubMed, J Am Acad Orthop Surg) - "Use of any prescription sleep medication or only standard sleep medications is associated with increased surgical complications. Additional research is needed to find medications that may be safer for routine postoperative use."

Journal • CNS Disorders • Musculoskeletal Diseases • Orthopedics • Pain • Psychiatry • Sleep Disorder

Polypharmacy, Outpatient Prescriptions and TBI Risk: a systematic review. (PubMed, Injury) - "In robust studies, antipsychotics, antidepressants, hypnotics, and opioids have all been associated with an increased risk of TBI, while studies on antithrombotics are inconsistent. Further studies are needed to evaluate the risk of these drugs in the general population, especially in the elderly."

Journal • Review • Addiction (Opioid and Alcohol) • CNS Disorders • Mood Disorders • Pediatrics

Z-Drug Use in the First Trimester of Pregnancy and Risk of Congenital Malformations. (PubMed, JAMA Psychiatry) - "At least 1 dispensing of Z-drugs (zaleplon, eszopiclone, or zolpidem) in the first trimester of pregnancy compared with no dispensing. Results were consistent across multiple sensitivity analyses. These findings suggest that Z-drug exposure in the first trimester of pregnancy is not associated with a meaningful elevation in the risk of congenital malformations overall, nor was there a consistent signal observed for organ-specific or uncommon, individual malformations examined."

Journal • CNS Disorders • Sleep Disorder

Lemborexant overdose presenting with mild sedation despite high plasma levels: A case report. (PubMed, Toxicol Rep) - "A 33-year-old woman presented to the emergency department four hours after ingesting an estimated 720 mg of lemborexant and 78 mg of eszopiclone. This case suggests that massive lemborexant overdoses may not cause life-threatening toxicity even when plasma levels approach those reported in fatal cases. This case provides preliminary but clinically important data and highlights the need for further research to better characterize the clinical implications and management of lemborexant overdoses."

Journal • Anesthesia • CNS Disorders • Depression • Insomnia • Psychiatry • Sleep Disorder

Sini-Suanzaoren decoction regulates mitochondrial biogenesis mediated by MT-SIRT1 in the treatment of insomnia rats. (PubMed, World J Psychiatry) - "SNSZRD might exert its therapeutic effects on insomnia by modulating MT-SIRT1 axis-regulated mitochondrial biogenesis in rats and might serve as an effective therapeutic agent for insomnia."

Journal • Preclinical • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder • NRF1 • PPARG • SIRT1

NAP: National Adaptive Trial for PTSD Related Insomnia (clinicaltrials.gov) - P3 | N=673 | Active, not recruiting | Sponsor: VA Office of Research and Development | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Insomnia • Post-traumatic Stress Disorder • Sleep Disorder

Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP) (clinicaltrials.gov) - P2 | N=42 | Completed | Sponsor: University of California, San Diego | Recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Oct 2025

Trial completion • Trial completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Efficacy of Eszopiclone Plus Acupuncture Therapy by Dispersing the Stagnated Liver-Qi and Regulating the Spirit for Treating Chronic Fatigue Syndrome-Related Sleep Disorders. (PubMed, Psychiatry Clin Psychopharmacol) - "Safety profiles favored the observation group, with fewer adverse reactions reported (7.02% vs 22.00%) (P=.026). Eszopiclone plus the acupuncture therapy enhances the efficacy of treating CFS-induced sleep disorders, effectively improves serum 5-HT and BDNF levels in patients, and reduces adverse reactions."

Journal • CNS Disorders • Fatigue • Infectious Disease • Sleep Disorder • BDNF

Effects of Shallow Needling for Chronic Primary Insomnia: Protocol for a Randomized Controlled Trial. (PubMed, JMIR Res Protoc) - "The control group will receive 1 mg eszopiclone orally, once a day for 4 weeks...This study will evaluate the therapeutic effectiveness and safety of shallow needling in the treatment of chronic insomnia to provide the necessary scientific basis for the clinical application and promotion of shallow needling. The findings of this study may provide a scientific and standardized treatment protocol for shallow needling in adults with chronic insomnia."

Clinical • Journal • CNS Disorders • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Too tired to learn: insomnia, sleep quality, and sleep aid practices among Kasr Al Ainy medical students: a cross-sectional analysis. (PubMed, BMC Med Educ) - "This study reveals the burden of sleep disturbance among medical students, with a major gap between the prevalence of insomnia and the utilization of professional sleep interventions. The off-label use of quetiapine, even among a small subset of our sample, raises notable safety concerns. This finding serves as an important pharmacovigilance signal and underscores the need for further investigation into the risks associated with this potentially hazardous practice. Non-pharmacological strategies such as sleep hygiene education and cognitive-behavioral interventions are needed."

Journal • CNS Disorders • Infectious Disease • Insomnia • Psychiatry • Sleep Disorder

Z-drug abuse and dependence: clinical guideline of the Brazilian Academy of Neurology for diagnosis and management. (PubMed, Arq Neuropsiquiatr) - "An advisory committee, consisting of neurologists from the Brazilian Academy of Neurology (Academia Brasileira de Neurologia, ABN, in Portuguese) and psychiatrists specializing in substance-use disorders, contributed to the selection and organization of the scientific literature and took part in the voting process. Key recommendations were established: 1) prior to discontinuation, a comprehensive assessment of mental status, psychiatric and sleep comorbidities, and the degree of pharmacological dependence is essential; 2) gradual tapering is advised; 3) non-pharmacological interventions, such as cognitive behavioral therapy for insomnia, are recommended, and acceptance and commitment therapy, which is optional, may be incorporated; 4) for zolpidem withdrawal, adjunctive pharmacotherapy, which is optional, may include trazodone, other antidepressants, quetiapine or other antipsychotics, alpha-2-delta (α2δ) ligands, or alternative hypnotics (such as ramelteon, zopiclone,..."

Clinical guideline • Journal • Review • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

A Randomized, Open-Label, Positive-Controlled Study on the Efficacy and Safety of Daridorexant, a GABA-A Receptor Partial Agonist, in the Treatment of Patients with Recurrent Depression Complicated by Insomnia (ChiCTR) - P4 | N=80 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New P4 trial • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Efficacy and safety of insomnia pharmacotherapies: Convergent evidence from Bayesian network meta-regression and FAERS-based disproportionality analysis. (PubMed, Sleep Med) - "Comprehensively considering the efficacy effect size, time windows (follow-up period, age, and types of insomnia), PV, severity of imperative adverse events, we propose prioritizing the use of daridorexant 25 mg/d for insomnia characterized by difficulty maintaining sleep and insufficient sleep duration. For insomnia characterized by difficulty falling asleep, we recommend prioritizing the use of lemborexant 10 mg/day or zolpidem 10 mg/day. For overall poor sleep efficiency, we recommend using lemborexant. Drug selection should be based on the types of insomnia and drug safety. More head-to-head clinical trials are needed to confirm those findings."

Journal • Review • CNS Disorders • Insomnia • Pulmonary Disease • Sleep Disorder