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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.
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
Upcoming trial readoutHigh impact
Results expected Q2 20272026-06-25
Upcoming trial readoutHigh impact
Results expected Q1 20312026-06-08
Clinical MilestonesView all 10Hide
Results posted
- 2026-02-04Effect of a Dual Orexin Receptor Antagonist, Lemborexant, on Total Sleep Time in Shift Workers: a Randomized Controlled TrialResults posted
- 2025-10-21A Pragmatic Randomized Comparator Trial of Eszopiclone and Brief Behavioral Therapy for Insomnia in CPAP Non Adherent Veterans With PTSD and Complex InsomniaResults posted
Results expected
- 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
- 2026-06-05Sequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in AdultsResults expected Q1 2032
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
+2 more in the activity timeline below
Activity timeline10
- 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
- 2026-06-05ClinicalSequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in AdultsResults expected Q1 2032
- 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
- 2026-02-04ClinicalEffect of a Dual Orexin Receptor Antagonist, Lemborexant, on Total Sleep Time in Shift Workers: a Randomized Controlled TrialResults posted
- 2025-10-21ClinicalA Pragmatic Randomized Comparator Trial of Eszopiclone and Brief Behavioral Therapy for Insomnia in CPAP Non Adherent Veterans With PTSD and Complex InsomniaResults posted
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
Approval — Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 ye… (2018)
Tasimelteonapproved
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.
First approvals
2018emaApproval — 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 ↗
2015emaApproval — 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.