zolpidem ER / Generic mfg. - LARVOL DELTA

TINA: Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder (clinicaltrials.gov) - P2 | N=222 | Recruiting | Sponsor: Apsen Farmaceutica S.A. | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2026 ➔ Aug 2026

Enrollment open • Trial initiation date • CNS Disorders • Insomnia • Sleep Disorder

SOMNUS: The Study in Outpatient Medicine Using Nudges to Improve Sleep (clinicaltrials.gov) - P=N/A | N=444 | Active, not recruiting | Sponsor: University of Southern California | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed

Effect of lemborexant on insomnia severity, morning alertness, and cognition in participants with insomnia disorder and mild obstructive sleep apnea. (PubMed, Sleep Med ) - P3 | "This post hoc analysis of study E2006-G000-304 (NCT02783729), a phase 3, randomized, double-blind, 1-month, parallel-group study of LEM 5 mg (LEM5), LEM 10 mg (LEM10), zolpidem tartrate extended-release 6.25 mg (ZOL), and placebo (PBO) included participants with insomnia and mild OSA (≥5 to <15 events/h sleep). ZOL negatively impacted power of attention and quality of memory cognitive domains at Days 2/3 and speed of memory retrieval at Days 30/31 versus PBO. LEM reduced insomnia severity without significantly impacting next-morning cognitive functioning and alertness in patients with mild untreated OSA."

Clinical • Journal • CNS Disorders • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Effects of lemborexant and zolpidem on sleep electroencephalography in older adults with insomnia: a randomized trial. (PubMed, Sleep Adv) - "Participants received 5 mg or 10 mg LEM (LEM5, LEM10), 6.25 mg extended-release zolpidem (ZOL), or placebo nightly for 30 days. ZOL showed similar REM effects, whereas LEM5, but not LEM10, reduced REM sigma and beta power. These findings demonstrate that ZOL and LEM differentially modulate sleep EEG, with sustained SO enhancement under LEM10 linked to symptom improvement."

Clinical • Journal • CNS Disorders • Insomnia • Sleep Disorder

Does Treatment for Insomnia Improve Sleep State Misperception? (AAN 2026) - "Design/Methods E2006-G000-304: 1-month, randomized, double-blind study of LEM 5mg (LEM5), LEM 10mg (LEM10), placebo (PBO), and zolpidem extended-release (ZOL) 6.25mg in participants with insomnia disorder aged ≥55 years. Q2 and Q3 had little change in discrepancy, whereas large differences remained in Q1. Conclusions While many participants with insomnia became more accurate in reporting their sleep parameters with treatment, sleep state misperception persisted in many individuals despite improvement in sleep."

CNS Disorders • Insomnia • Sleep Disorder

Hypnotic-Induced Fall Risk Upon Awakening: A Network Meta-Analysis of Postural Stability Outcomes. (PubMed, J Sleep Res) - "Most in-label doses of hypnotics showed no significant impact on postural stability in the morning compared to placebo, except zopiclone 7.5 mg both at bedtime (Standardized Mean Difference-SMD = 0.22, 95% C.I.[0.22;0.1.24]) and middle-of-the-night awakening (SMD = 4.45, 95% C.I.[3.54;5.36]), while zolpidem 6.5 mg extended-release proved worse in the subset including older adults (SMD = 0.39, 95% C.I.[0.01;0.76])...Given the age-related decline in postural reflexes and heightened sensitivity to CNS depressants, lower doses and shorter half-life drugs should be preferred whenever hypnotic therapy is necessary. Future research is needed to explore dynamic balance further to optimize prescribing guidelines for fall prevention in vulnerable populations."

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

TINA: Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder (clinicaltrials.gov) - P2 | N=222 | Not yet recruiting | Sponsor: Apsen Farmaceutica S.A.

New P2 trial • CNS Disorders • Insomnia • Sleep Disorder

The Effects of Lemborexant on Objective Sleep Parameters in Insomnia Patients Based on Sleep State Misperception (WSS 2025) - "Materials and Study E2006-G000-304 was a 1-month, randomized, double-blind, placebo (PBO)– and zolpidem extended-release (ZOL; not reported here)–controlled trial in patients aged 55 years and older who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for insomnia disorder with an Insomnia Severity Score ≥13. LEM improved objective sleep parameters in insomnia patients, regardless of the magnitude of sleep state misperception."

Clinical • CNS Disorders • Insomnia • Mental Retardation • Psychiatry • Sleep Disorder

The Effects of Lemborexant on Subjective Sleep Parameters in Insomnia Patients Based on Sleep State Misperception (WSS 2025) - "Materials and Study E2006-G000-304 was a 1-month, randomized, double-blind, placebo (PBO)– and zolpidem extended-release (ZOL; not reported here)–controlled trial in patients aged 55 years and older who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for insomnia disorder with an Insomnia Severity Score ≥13. LEM improved subjective sleep parameters in insomnia patients, regardless of the magnitude of sleep state misperception."

Clinical • CNS Disorders • Insomnia • Mental Retardation • Psychiatry • Sleep Disorder

Consistency of Objective Results on Sleep Onset and Sleep Maintenance Parameters From Global Studies of Lemborexant (WSS 2025) - "Study 304 also included zolpidem extended-release, and Studies 204 and 304 included LEM 5 mg (not discussed here). These data support the view that LEM is an effective and well-tolerated treatment for patients with insomnia without influence by race/national origin."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

A Mechanistic study assessing difficulty discontinuing chronic hypnotic use. (PubMed, Psychopharmacology (Berl)) - "Most subjects discontinued hypnotic use and among the few continuing to use their use declined from week one to week two of the discontinuation period."

Journal • CNS Disorders • Insomnia • Mental Retardation • Psychiatry • Sleep Disorder

Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apnea. (PubMed, Sleep Med) - P3 | "LEM significantly increased TST in participants with insomnia and mild OSA. Importantly, REM sleep, associated with cognitive performance, increased. These data support the use of LEM in patients with insomnia and mild OSA."

Journal • CNS Disorders • Insomnia • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Sleep Disorder

Dispensing of zolpidem and benzodiazepines in Brazilian private pharmacies: a retrospective cohort study from 2014 to 2021. (PubMed, Front Pharmacol) - "Throughout the entire period, clonazepam emerged as the most popular drug, accounting for 29.8% of total sales. Alprazolam followed in second place with 20.6% of sales, while zolpidem came in third with 14.4%...In contrast, the extended-release form of zolpidem remained stable over the years...The epidemic of sleeping pills arises in a scenario of expectancy of short-term amelioration of symptoms, with no correspondence in best clinical practice. Education and counseling for both healthcare professionals and the general population are essential to address this growing health concern and ensure the safe and appropriate use of medications for sleep disorders."

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

SOMNUS: The Study in Outpatient Medicine Using Nudges to Improve Sleep (clinicaltrials.gov) - P=N/A | N=390 | Enrolling by invitation | Sponsor: University of Southern California | Not yet recruiting ➔ Enrolling by invitation

Enrollment open

SOMNUS: The Study in Outpatient Medicine Using Nudges to Improve Sleep (clinicaltrials.gov) - P=N/A | N=390 | Not yet recruiting | Sponsor: University of Southern California

New trial

Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. (PubMed, Drugs Aging) - P1, P3 | "LEM provided benefits on sleep variables without next-morning residual effects in subjects aged ≥ 65 years, supporting LEM as a treatment option for older adults with insomnia."

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

Insomnia and the effect of zolpidem-extended-release on the sleep items of the Hamilton Rating Scale for Depression in outpatients with depression, insomnia, and suicidal ideation: Relationship to patient age. (PubMed, J Psychopharmacol) - P4 | "These findings are consistent with the known age-related advancement of sleep timing in the general population and depressed outpatients and with the expected effects of a short half-life GABA allosteric modulator sleep aid. By implication, prescribers of pharmacologic treatment of insomnia in depressed patients should consider an alternative to zolpidem-ER when late insomnia is a concern.Trial registration number: ClinicalTrials.gov Identifier: NCT01689909."

Journal • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Psychiatry • Sleep Disorder • Suicidal Ideation

Mood and Difficulty Discontining Chronic Hypnotic Use (CPDD 2024) - "Following a screening NPSG participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg), or placebo nightly for 6 months. The majority (51%) of the participants discontinued 6-months of nightly hypnotic use. Higher depression scores (BDI II) were predictive of difficulty discontinuing chronic hypnotic use."

CNS Disorders • Depression • Insomnia • Mental Retardation • Psychiatry • Sleep Disorder

Lemborexant Treatment in Older Adults with Insomnia and Objective Short Sleep: Rates of Response and Remission (AAN 2024) - P3 | "Since subjects with insomnia with I-SSD (50% considered treatment responders. LEM is a potential therapy for patients with I-SSD, including those with limited response to CBT-I."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

The effect of zolpidem-CR on the suicide item of the Hamilton Rating Scale for Depression in outpatients with depression, insomnia and suicidal ideation: Lessons learned. (PubMed, Psychiatry Res) - "This secondary analysis of the REST-IT data examined the suicide item of another observer-rated scale, the Hamilton Rating Scale for Depression (HRSD), further clarifying the impact of insomnia-focused treatment on suicidal ideation. This analysis established a significant advantage for zolpidem-CR compared with placebo on the HRSD suicide item."

Journal • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder • Suicidal Ideation

Randomized controlled trial of zolpidem as a pharmacotherapy for cannabis use disorder. (PubMed, J Subst Use Addict Treat) - "Results from this randomized controlled trial suggest that zolpidem-XR can attenuate abstinence-induced sleep disturbance early in treatment for CUD, but that sleep problems are likely to emerge after the medication is stopped. Further research should identify alternative pharmacotherapies and behavioral treatments for CUD and elucidate the role of sleep disturbance in the development and maintenance of CUD."

Journal • CNS Disorders • Insomnia • Sleep Disorder • Substance Abuse

Controlled-release zolpidem improves freezing of gait and levodopa-induced dyskinesias in a patient with Parkinson’s disease. (MDS Congress 2023) - "After a brief time in the limelight, the field lost interest in zolpidem as a treatment for Parkinson’s disease. It is possible that side effects such as drowsiness prevented zolpidem from becoming a viable treatment alternative. More studies are needed to understand if zolpidem could be one alternative for patients who are unable to undergo deep brain stimulation and are troubled by motor fluctuations."

Clinical • CNS Disorders • Dystonia • Parkinson's Disease • Psychiatry

Comparison of the treatment effectiveness between lemborexant and zolpidem tartrate extended release for insomnia disorder subtypes (WSS 2023) - P3 | "LEM consistently showed subjective and objective benefits compared with PBO in subjects with insomnia who had I-SSD. ZOL also showed benefits compared with PBO, but with less consistency, particularly for sleep onset measures. Neither drug provided consistent benefits on sleep-onset and sleep maintenance variables for subjects with I-NSD.Acknowledgements: Funded by Eisai Inc."

CNS Disorders • Insomnia • Sleep Disorder

Comparison of the treatment effectiveness between lemborexant and zolpidem tartrate extended release for subjective- and objective insomnia (WSS 2023) - No abstract available

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Effect Of Lemborexant On Subjective/Objective Sleep Onset And Maintenance In Patients With Comorbid Insomnia And Mild Obstructive Sleep Apnea (CINP 2023) - P3 | " Study 304 (NCT02783729) was a 1-month, randomized, double-blind, placebo (PBO)- and active-comparator (zolpidem tartrate extended-release 6.25 mg [ZOL; not reported here])-controlled study of LEM 5mg (LEM5) and LEM10.4 Subjects (≥55y) with insomnia disorder and sleep maintenance problems were enrolled. LEM significantly improves subjective and objective sleep measures compared to placebo. Because LEM does not negatively impact the AHI in patients with mild-to-severe OSA, it may be a valid treatment option for COMISA. Support: Eisai Inc."

Clinical • CNS Disorders • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder