Phase 3 N=295 A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Insomnia
Primary: Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline — 68.13; 69.42 minutes
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=194 A Study of Lemborexant in Chinese Participants With Insomnia Disorder
Sleep Initiation and Maintenance Disorders
Primary: Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo — -21.71; -39.47…
Phase 3 N=82 A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Insomnia
Primary: Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography — 9.69; 16.89; 28.12 minutes — p=<0.001
N/A N=188 Sleep Without Insomnia or The Use of Chronic Hypnotics
Sleep Initiation and Maintenance Disorders
Primary: Rates of Hypnotic Discontinuation — 64; 52 Participants — p=.039
Phase 3 N=1,006 Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
Insomnia
Primary: Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 — 43.89; 44.86; 44.61; -7.93…
N/A N=45 A High Density EEG Comparison of Sleep Patterns in Insomnia
Primary Insomnia
Primary: EEG Power During Sleep — 1.40; 1.17 μV^2/Hz — p=0.2791
N/A N=154 Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Menopause
Primary: Diary Based Sleepiness — 5.01; 5.13; 4.87; 4.72 score on a scale
Phase 4 N=41 Suvorexant and Trauma Related Insomnia
Insomnia · Posttraumatic Stress Disorder
Primary: Change in Insomnia Severity Index Score From Baseline. — 6.8; 8.6 units on a scale — p=<.05
N/A N=20 Sleep Loss and Mechanisms of Impaired Glucose Metabolism
Primary Insomnia
Primary: Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test — .33; -0.10 %/min, slope of natural log glucose
Phase 3 N=971 Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
Insomnia Disorder
Primary: Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 — 64.03; 62.19; 64.97; -16.57 minutes — p=<.0001
Phase 4 N=69 Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
Sleep Disorders
Primary: Change in Pittsburgh Sleep Quality Index — -0.86; -3.15; -3.32 difference score of PSQI total
N/A N=30 Chronic Insomnia and CSF Markers of Dementia
Insomnia Chronic
Primary: CSF Markers Related to Dementia — 4332.1; 4824.0; 393.2; 419.4 picograms per milliliter
N/A N=245 The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy
Insomnia
Primary: Insomnia Severity Index (ISI) — 15.9; 15.4; 12.7; 11.6 score on a scale — p=0.001
N/A N=92 Sleep IntervEntion as Symptom Treatment for ADHD
ADHD · Sleep · Adolescents
Primary: Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test — 8.11; 7.94; 8.03; 8.07 hours — p=.17
Phase 3 N=1,022 Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
Primary Insomnia
Primary: Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 — 42.6; 23.1 minutes — p=<0.00001
Phase 2 N=360 Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Insomnia Disorder
Primary: Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 — -28.4; -32.3; -37.7; -47.1 minutes — p=<0.001
N/A N=211 Sequenced Therapies for Comorbid and Primary Insomnias
Insomnia Comorbid to Psychiatric Disorder · Primary Insomnia
Primary: Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index — 40.00; 34.94; 37.04; 48.15 percent remitted
Phase 4 N=115 Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
Insomnia · Insomnia Chronic
Primary: Treatment Response (Phase 1) — 94 Participants
Phase 3 N=30 Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Chronic Insomnia · Primary Insomnia
Primary: Pittsburgh Sleep Quality Index (PSQI) — 7.7; 9.2; 7.0; 8.2 units on a scale
Phase 2 N=137 Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
Primary Insomnia
Primary: Latency to Persistent Sleep — -22.7; -39.1; -37.5 minutes
N/A N=27 Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Mild Cognitive Impairment · Insomnia
Primary: Sleep Latency — 28.51; 47.06 minutes
Phase 2 N=58 Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Insomnia Disorder
Primary: Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 — -18.9; -32.0; -45.1; -61.4 minutes — p=<0.001
Phase 2 N=118 Internet-based Treatment for Chronic Insomnia
Insomnia · Insomnia Disorder
Primary: Sleep Quality — 1.77; 2.18 0-4 scale of sleep quality
Phase 2 N=20 Zaleplon in HIV Patients With Depression
HIV/AIDS · Clinical Depression
Primary: Insomnia Severity Index (ISI) — 11 score on a scale
Phase 3 N=28 The Efficacy of Suvorexant in Treatment of Patients With Substance Use Disorder and Insomnia: A Pilot Open Trial
Sleep Disturbance · Craving · Cortisol; Hypersecretion
Primary: Change in Total Sleep Time as Measured by Actigraphy and Sleep Logs Relative to Baseline Over the Course of 7 Days of Treatment With Suvorexant in Substance Use Disorder…
Phase 3 N=126 Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Insomnia · End Stage Renal Disease
Primary: Insomnia Severity Index (ISI) Short-term — 12.47; 11.97; 13.05 score on a scale — p=0.6761
Phase 4 N=67 Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
Type 2 Diabetes Mellitus · Insomnia · Sleep Disorder
Primary: Subjective Total Sleep Time — 6.4; 7.0; 6.7; 6.7 hours — p=0.15
Phase 3 N=460 A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
Sleep Initiation and Maintenance Disorders · Mental Disorders · Dyssomnias
Primary: Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period — 65.9; 19.3 minutes — p=<0.0001
N/A N=28 Hyper-Arousal in Chronic Primary Insomnia
Chronic Insomnia
Primary: Sympathetic Baroreflex Sensitivity (BRS) Unit — -2.1; -4.3 bursts per 100 heart beats per mm Hg
Phase 2 N=40 Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
Insomnia
Primary: Change in Daytime Insomnia Symptoms Scale (DISS) — 65.96; 70.34; 69.22; 72.32 units on a scale