Sleep Initiation and Maintenance Disorders
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-06-10EMA Authorised: Slenyto (melatonin) — RAD Neurim Pharmaceuticals EEC SARL
Slenyto (melatonin) has been authorized for sleep initiation and maintenance disorders and autistic disorder in the EU.
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CLINICAL_TRIALS research · 2025-12-22Clinical Trial Update: Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia [NA]
This clinical trial update notes a NOT_YET_RECRUITING study evaluating a novel digital therapeutic for insomnia.
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CLINICAL_TRIALS trial_result · 2025-12-11Clinical Trial Update: Sensory-Friendly Physical Activity for Sleep in Autistic Children [NA]
A completed clinical trial investigating sensory-friendly physical activity to improve sleep in children with autism spectrum disorder.
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CLINICAL_TRIALS trial_result · 2024-12-30Clinical Trial Update: Sleep Without Insomnia or The Use of Chronic Hypnotics [NA]
UCLA-sponsored clinical trial titled "Sleep Without Insomnia or The Use of Chronic Hypnotics" has completed. Results have been posted for Sl…
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CLINICAL_TRIALS research · 2024-10-23Clinical Trial Update: Precision Transcranial Magnetic Stimulation for Patients With Post-stress Sleep Disorders [NA]
This is a clinical trial update on precision transcranial magnetic stimulation for post-stress sleep disorders. The study is currently NOT_Y…
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CLINICAL_TRIALS trial_result · 2024-10-23Clinical Trial Update: Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers [NA]
A University of Virginia-led study evaluated digital health interventions for family caregivers dealing with insomnia; the trial completed a…
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CLINICAL_TRIALS research · 2024-08-07Clinical Trial Update: Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol
A completed observational prospective study protocol evaluating the use of a Samsung smartwatch to monitor sleep quality in individuals with…
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EMA approval · 2023-09-15EMA Authorised: Melatonin Neurim (melatonin) — RAD Neurim Pharmaceuticals EEC SARL
EU authorization of Melatonin Neurim (melatonin) for sleep initiation and maintenance disorders.
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CLINICAL_TRIALS research · 2023-02-09Clinical Trial Update: Insomnia Self-Management in Heart Failure [NA]
Clinical trial update on insomnia self-management in heart failure; study completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-12-16Clinical Trial Update: Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD [Phase 4]
Phase 4 clinical trial update assessing the effect of auricular acupoint pressing on insomnia and adverse events in patients undergoing hemo…
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CLINICAL_TRIALS trial_result · 2020-08-05Clinical Trial Update: Understanding the Sleep Apnea/Insomnia Interaction [NA]
A completed clinical trial from the University of Pennsylvania explored the interaction between sleep apnea and insomnia with results posted…
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CLINICAL_TRIALS trial_result · 2019-12-24Clinical Trial Update: HIRREM Developmental Study [NA]
Clinical trial update for the HIRREM developmental study; the study is completed with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-10-16Clinical Trial Update: Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061) [Phase 3]
Phase 3 trial assessing safety and efficacy of suvorexant for insomnia in individuals with Alzheimer’s disease has completed with results po…
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CLINICAL_TRIALS trial_result · 2019-08-29Clinical Trial Update: Telemedicine Management of Chronic Insomnia [NA]
Clinical trial update on telemedicine management for chronic insomnia, completed with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-08-28Clinical Trial Update: CBT-I for Cannabis Use [NA]
A terminated clinical trial investigating cognitive-behavioral therapy for insomnia (CBT-I) in individuals with cannabis use/marijuana abuse…
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CLINICAL_TRIALS trial_result · 2017-12-13Clinical Trial Update: Improving Sleep and Psychological Functioning in People With Depression and Insomnia [Phase 4]
Phase 4 trial evaluating interventions to improve sleep and psychological functioning in people with depression and insomnia has completed w…
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CLINICAL_TRIALS trial_result · 2017-03-29Clinical Trial Update: Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease [NA]
Clinical trial update for light therapy to address sleep/wake disturbances in Alzheimer's disease; study status completed with results poste…
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CLINICAL_TRIALS trial_result · 2017-02-17Clinical Trial Update: Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography [Phase 4]
Phase 4 post-marketing study evaluating zolpidem Myslee in adolescents with insomnia, assessed by polysomnography (study completed).
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EMA withdrawal · 2015-10-21EMA Withdrawn: Sonata (zaleplon) — Meda AB
The EMA has withdrawn Sonata (zaleplon) from the market in Europe (MAH: Meda AB) with a decision dated 03/07/2015.
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CLINICAL_TRIALS trial_result · 2014-10-30Clinical Trial Update: Modafinil Treatment for Sleep/Wake Disturbances in Older Adults [Phase 4]
Phase 4 trial evaluating modafinil for sleep/wake disturbances in older adults; terminated with results posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-08-05Clinical Trial Update: Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709) [Phase 3]
Phase 3 trial updating efficacy and safety of Org 50081 (Esmirtazapine) in elderly with insomnia-related disorders; results posted after com…
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CLINICAL_TRIALS trial_result · 2014-08-01Clinical Trial Update: A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002) [Phase 3]
A Phase 3 clinical trial update reports on the 6-month efficacy and safety of Org 50081 in adults with chronic primary insomnia; results hav…
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CLINICAL_TRIALS trial_result · 2012-11-27Clinical Trial Update: Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder [NA]
A clinical trial update indicates termination of a study evaluating prazosin for post-traumatic stress disorder related to noncombat trauma,…
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EMA withdrawal · 2012-10-15EMA Withdrawn: Zerene (zaleplon) — Meda AB
EMA has withdrawn Zerene (zaleplon) from the market (Meda AB) for sleep initiation and maintenance disorders.
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CLINICAL_TRIALS research · 2012-01-13Clinical Trial Update: Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease [NA]
This entry reports a completed clinical trial evaluating behavioral programs to treat sleep problems in individuals with Alzheimer's disease…