zolpidem ER / Generic mfg. - LARVOL DELTA

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

BZRA Hypnotic Receptor Specificity and Ability to Discontinue Chronic Hypnotic Use (SLEEP 2023) - "Following a screening polysomnogram and MSLT, participants were randomized to zolpidem XR 12.5 mg (n=16), eszopiclone 3 mg (n=11), or placebo (n=14) nightly for 6 months. The non-hypnotic receptor specific eszopiclone group took a greater number of capsules than the placebo group. This is the first ­demonstration of differential abuse liability among BzRA hypnotics."

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

Chronic change in sleep oscillation expression in older adults with insomnia with zolpidem or lemborexant and its effect on memory (SLEEP 2023) - P3 | "Methods 116 older adults (71.01±4.81y, 78.67% female) with insomnia (Insomnia Severity Index 18.73±3.13) completed a phase 3 study (E2006-G000-304; NCT02783729) with placebo (n=29), zolpidem-extended-release (6.25mg,n=26;ZOL), and lemborexant (5mg,n=29[LEM5]; 10mg,n=32[LEM10]) using polysomnography before (at baseline) and 29-30 days after chronic treatment. Conclusion In older adults with insomnia disorder, chronic treatment with lemborexant and zolpidem had distinct effects on sleep oscillation expression and between power and memory. Functional consequences of these differential effects on sleep-oscillation expression and memory in insomnia patients should be further considered."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Differential Effect of Lemborexant and Zolpidem on Wake Across the Night in Patients with Insomnia Disorder (SLEEP 2023) - P3 | "While zolpidem tartrate extended-release 6.25mg (ZOL) is indicated to treat sleep onset and maintenance, data indicate that ZOL may be less effective in the last 2 hours of the night. Conclusion LEM improves total sleep time by decreasing wake time throughout the night after sleep onset compared to PBO, and at the beginning/end of the night compared to ZOL. These findings support that ZOL may be less effective in maintaining sleep during the last 2 hours of the night compared with LEM in older subjects, especially those with sleep maintenance difficulties."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Effect of Lemborexant on Sleep Architecture in Subjects with Comorbid Insomnia and Mild Obstructive Sleep Apnea from a Ph 3 Trial (SLEEP 2023) - P3 | "Subjects received PBO, LEM 5mg (LEM5), LEM 10mg (LEM10) or zolpidem tartrate extended-release 6.25mg (ZOL). The additional sleep was comprised importantly with REM sleep, a sleep stage that may be decreased in patients with OSA. These data support the use of LEM in a population with COMISA."

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

Impact of Lemborexant on Daytime Ratings of Sleepiness/Alertness in Subjects with Insomnia Disorder and Baseline Sleepiness (SLEEP 2023) - P3 | "Subjects received bedtime doses of placebo (PBO), LEM 5mg (LEM5), LEM 10mg (LEM10), or zolpidem tartrate extended release 6.25 mg (not reported here) for 1 month. More subjects who reported sleepiness at baseline and received LEM reported improved morning alertness during the last week of treatment compared with PBO subjects. These data are concordant with previous findings of a lack of effect of LEM on tasks requiring alertness in the morning."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Hyperarpusal/Sleep Disturbance and Inability to Discontinue Chronic Hypnotic Use (CPDD 2023) - "Following a screening polysomnogram and MSLT, participants were randomized to zolpidem XR 12.5 mg (n=16), eszopiclone 3 mg (n=11), or placebo (n=14) nightly for 6 months. The majority (51%) of the participants discontinued 6-month nightly hypnotic use and among those taking capsules the rate declined from week 1 to 2. Hyperarousal and sleep disturbance may help identify those with difficulty discontinuing chronic hypnotic use."

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

Effect of Lemborexant Treatment on Polysomnographic Sleep Measures in Older Adults with Insomnia and Objective Short Sleep Duration (ASCP 2023) - P3 | "Thus, we evaluated sleep parameters with lemborexant (LEM) versus zolpidem tartrate extended release 6.25 mg (ZOL) and placebo (PBO) in subjects with I-SSD. These results support LEM as an effective therapy for older patients with I-SSD and suggest LEM may be more beneficial than ZOL in these patients, especially when a behavioral therapy may have limited efficacy. Support: Eisai Inc. Learning Objectives To increase awareness of the specific impact of insomnia and objective short-sleep duration."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Effect of Lemborexant on Sleep Onset and Sleep Maintenance in Patients with Comorbid Insomnia Disorder and Mild Obstructive Sleep Apnea (ASCP 2023) - P3 | " Study E2006-G000-304 (Study 304; NCT02783729) was a 1-month, randomized, double-blind, placebo (PBO)-controlled and active-comparator (zolpidem tartrate extended release 6.25 mg [ZOL]) study of LEM 5 mg (LEM5) and LEM 10 mg (LEM10) in subjects age ≥55 y (Rosenberg, 2019). These results demonstrate the effectiveness of LEM versus PBO and ZOL in an older patient population with insomnia disorder and mild OSA. Support: Eisai Inc. Learning Objectives Learners will be able to explain the impact of lemborexant on sleep parameters in patients with comorbid insomnia disorder and OSA (COMISA) of mild severity."

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

Effect of Lemborexant Treatment on Polysomnographic Sleep Measures in Older Adults with Insomnia and Objective Short Sleep Duration (AAN 2023) - P3 | "Objective To evaluate sleep parameters with lemborexant (LEM) versus zolpidem tartrate extended-release 6.25mg (ZOL) in subjects with insomnia and objective short-sleep duration (I-SSD), defined as total sleep time (TST) <6h. Conclusions These results support LEM as an effective therapy for older patients with I-SSD and suggest LEM may be more beneficial than ZOL in these patients. Thus, LEM may be reasonably considered for treating older patients with I-SSD where behavioral therapy may have relatively limited efficacy."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Effect of Lemborexant on Sleep Onset and Maintenance in Patients with Comorbid Insomnia Disorder and Mild Obstructive Sleep Apnea (AAN 2023) - P3 | "Design/Methods Study E2006-G000-304 (Study 304; NCT02783729) was a 1-month, randomized, double-blind, placebo (PBO)-controlled and active-comparator (zolpidem tartrate extended release 6.25mg [ZOL]) study of LEM 5mg (LEM5) and LEM 10mg (LEM10). LEM was well tolerated and consistent with its known safety profile. Conclusions These results demonstrate the effectiveness of LEM versus PBO and ZOL in an older patient population with untreated COMISA of mild severity."

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