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Disease
Sleep disorder
Late-stage therapeutic development
Also known as disturbances, sleep, sleep disturbance, sleep disturbances, parasomnia.
24
Clinical trials
12
Associated genes
2
Related proteins
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Moderate
Key developments
- 3 clinical trials expected to report results, the earliest in Q2 2027.
- 1 industry development reported.
Upcoming Milestones
- Q2 2027Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
- Q1 2031CELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal People
- Q1 2032Sequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in Adults
Major developments
Major trial resultsHigh impact
Results posted2026-07-23
Upcoming trial readoutHigh impact
Results expected Q1 20322026-09-16
Clinical MilestonesView all 9Hide
Results posted
- 2026-07-23Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant AdministrationResults posted
Results expected
- 2026-09-16Sequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in AdultsResults expected Q1 2032
- 2026-06-25Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer DiseaseResults expected Q2 2027
- 2026-06-08CELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal PeopleResults expected Q1 2031
Recently completed
- 2026-04-30The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia DisorderCompleted
- 2026-03-30CSP #2016 - National Adaptive Trial for PTSD Related InsomniaCompleted
- 2026-03-20Effect of Eszopiclone on Adherence to Continuous Positive Airway Pressure (CPAP) and Severity of Insomnia in Patients With Comorbidity Between Insomnia and Obstructive Sleep Apnea (COMISA)Completed
Other updates
- 2026-07-08A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Upadacitinib on Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis (SLEEP UP)Withdrawn
- 2026-02-17Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer SurvivorsTerminated
+1 more in the activity timeline below
Industry & MarketViewHide
- 2026-10-07<![CDATA[First Patient Dosed in Phase 2a Trial of GlyphAgo for Generalized Anxiety Disorder and Sleep Disturbance]]>Trial news · Psychiatric Times
Activity timeline10
- 2026-10-07Industry<![CDATA[First Patient Dosed in Phase 2a Trial of GlyphAgo for Generalized Anxiety Disorder and Sleep Disturbance]]>Trial news · Psychiatric Times
- 2026-09-16ClinicalSequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in AdultsResults expected Q1 2032
- 2026-07-23ClinicalImprovement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant AdministrationResults posted
- 2026-07-08ClinicalA Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Upadacitinib on Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis (SLEEP UP)Withdrawn
- 2026-06-25ClinicalDaridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer DiseaseResults expected Q2 2027
- 2026-06-08ClinicalCELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal PeopleResults expected Q1 2031
- 2026-04-30ClinicalThe Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia DisorderCompleted
- 2026-03-30ClinicalCSP #2016 - National Adaptive Trial for PTSD Related InsomniaCompleted
- 2026-03-20ClinicalEffect of Eszopiclone on Adherence to Continuous Positive Airway Pressure (CPAP) and Severity of Insomnia in Patients With Comorbidity Between Insomnia and Obstructive Sleep Apnea (COMISA)Completed
- 2026-02-17ClinicalDouble-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer SurvivorsTerminated
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approved & established therapies
Melatoninapproved
Original application approval — Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 ye… (2018)
Tasimelteonapproved
Original application approval — Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in tot… (2015)
Clinical trials
The current development programme across all trial phases.
Clinical programme
24
6
18
6
Late-stage studies
Recruiting
Recently completed
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
Product approvals and authorisations
2018emaOriginal application approval — Melatonin· Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient. source ↗
2015emaOriginal application approval — Tasimelteon· Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults. source ↗
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
Reference
Authoritative identity, definition & identifiers.
Synonyms
disturbances, sleep, sleep disturbance, sleep disturbances, parasomnia
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Related entities are derived from literature co-mention (studied together) — associative, not causal.