Insomnia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2013-05-10Clinical Trial Update: Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance [Phase 3]
Phase 3 add-on trial of ramelteon for sleep disturbance in bipolar I disorder was terminated.
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CLINICAL_TRIALS trial_result · 2013-04-23Clinical Trial Update: Group Cognitive Behavioral Therapy (CBT I) Vs. Quetiapine for Residual Insomnia Impairing Recovery Among Elderly With Stable Major Affective Disorders [Phase 2, Phase 3]
This completed Phase 2/Phase 3 trial compares group CBT I with quetiapine for residual insomnia impairment in elderly patients with stable m…
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FDA approval · 2013-04-19FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental NDA for zolpidem tartrate filed by Sanofi-Aventis U.S. LLC.
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FDA approval · 2013-04-19FDA Approved: EDLUAR — Supplemental Application (Viatris Specialty LLC)
The FDA approved Viatris Specialty LLC's supplemental application for EDLUAR (zolpidem tartrate), a brand product used to treat insomnia.
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FDA approval · 2013-04-19FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for AMBIEN (zolpidem tartrate) from Cosette Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2013-04-10Clinical Trial Update: Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia [Phase 3]
Phase 3 trial evaluating the safety and efficacy of eszopiclone in children and adolescents with ADHD-associated insomnia completed; results…
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FDA approval · 2013-04-03FDA Approved: ESZOPICLONE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical's original application for eszopiclone, a generic sleep aid used to treat insomnia.
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CLINICAL_TRIALS trial_result · 2013-03-29Clinical Trial Update: Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study [Phase 2, Phase 3]
A pilot Phase 2/3 trial comparing mindfulness-based therapy with pharmacotherapy for chronic insomnia, with results posted in 2013.
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FDA approval · 2013-03-26FDA Approved: ESZOPICLONE — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved Mylan's original ANDA for eszopiclone, making a generic version of the sleep medication available for adults with insomnia.
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CLINICAL_TRIALS trial_result · 2013-03-20Clinical Trial Update: Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood [NA]
The University of Hawaii-sponsored trial evaluating the dietary supplement 5-ALA for sleep and mood has completed. The study focused on inso…
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CLINICAL_TRIALS trial_result · 2013-03-11Clinical Trial Update: Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia [Phase 2]
Phase 2 clinical trial update evaluating almorexant (ACT-078573) for chronic primary insomnia in elderly subjects; the study is completed an…
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CLINICAL_TRIALS trial_result · 2013-02-12Clinical Trial Update: A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102) [Phase 1]
A Phase 1 bioequivalence and food effect study of SEP-190 in Japanese healthy subjects has completed, with results posted.
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CLINICAL_TRIALS trial_result · 2013-02-07Clinical Trial Update: Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia [Phase 3]
Phase 3 trial update for Almorexant (ACT-078573) in adults with chronic primary insomnia; the study completed and results were posted in 201…
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FDA label_change · 2013-02-04FDA Approved: ADVIL PM — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application to Advil PM for labeling updates related to the combination of diphenhydramine HCl and ibuprofen (sl…
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CLINICAL_TRIALS trial_result · 2013-02-04Clinical Trial Update: A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126) [Phase 2, Phase 3]
Updates on a Phase II/III trial of SEP-190 (eszopiclone) for primary insomnia, with results posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-02-01Clinical Trial Update: Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 [Phase 2]
Phase 2 study evaluating sleep-maintenance activity of three doses of SKP-1041 in adults with primary insomnia. The trial has completed and …
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FDA approval · 2013-01-25FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for HALCION (triazolam) submitted by Pharmacia & Upjohn Company LLC.
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CLINICAL_TRIALS trial_result · 2013-01-21Clinical Trial Update: Cortical GABA Concentrations in Insomnia
A completed Yale University–sponsored trial examined cortical GABA concentrations in people with insomnia, with and without major depressive…
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CLINICAL_TRIALS trial_result · 2013-01-08Clinical Trial Update: Internet Delivered Self-Help CBT for Insomnia [Phase 3]
Phase 3 trial evaluating internet-delivered self-help cognitive behavioral therapy for insomnia has completed.
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CLINICAL_TRIALS trial_result · 2013-01-08Clinical Trial Update: Online Self-Help Intervention for Insomnia: With or Without Feedback [Phase 3]
A Phase 3 clinical trial evaluating an online self-help insomnia intervention, with and without feedback, has completed.
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CLINICAL_TRIALS trial_result · 2012-12-28Clinical Trial Update: Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women [Phase 3]
Phase 3 trial evaluating the effect of estrogen therapy on objective sleep quality in postmenopausal women with insomnia has completed.
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CLINICAL_TRIALS trial_result · 2012-12-11Clinical Trial Update: Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems [Phase 1, Phase 2]
This clinical trial evaluated mindfulness training to improve sleep and reduce inflammation in older adults with sleep problems; Phase 1 and…
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CLINICAL_TRIALS trial_result · 2012-11-22Clinical Trial Update: A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150) [Phase 3]
Phase III study of eszopiclone for insomnia completed with results posted in 2012.
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CLINICAL_TRIALS withdrawal · 2012-11-22Clinical Trial Update: Metacognitive Therapy for Comorbid Insomnia [NA]
The clinical trial evaluating metacognitive therapy for secondary insomnia was withdrawn.
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CLINICAL_TRIALS trial_result · 2012-11-20Clinical Trial Update: Ramelteon in Adults With Chronic Insomnia [Phase 3]
This document provides an update on a Phase 3 trial of ramelteon in adults with chronic insomnia.