Sleep Initiation and Maintenance Disorders
Recent clinical, regulatory, research and industry developments relating to this disease.
The Prevalence of Insomnia Disorder in the General Population: A Meta-Analysis.
Sleep and cardiovascular disease.
The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023.
Bidirectional mechanism of comorbidity of depression and insomnia based on synaptic plasticity.
Cognitive behavioural therapy for insomnia in inpatient psychiatric care: a systematic review.
Cognitive behavioural therapy for insomnia disorder: Extending the stepped care model.
The burden of untreated insomnia disorder in a sample of 1 million adults: a cohort study.
Approval: Slenyto (EMA)
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 3 clinical trials expected to report results, the earliest in Q2 2027.
- 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
Clinical MilestonesView all 10Hide
- 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
- 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
- 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
- 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
- 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
Clinical trials
The current development programme across all trial phases.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Sleep Initiation and Maintenance Disorders13
- Cognitive Behavioral Therapy3
- Anxiety1
- Betacoronavirus1
- Cardiovascular Diseases1
- Coronavirus Infections1
- Depression1
- Melatonin1
Leading journals6
- Journal of sleep research6
- JAMA network open2
- Sleep2
- BMC public health1
- Emerging topics in life sciences1
- International journal of biological sciences1
Leading researchers8
- Espie CA4
- Riemann D4
- Altena E3
- Baglioni C3
- Holzinger B3
- Jernelöv S3
- Gavriloff D2
- Geoffroy PA2
Affiliations (unnormalised)6
- Department of Clinical Neuroscience3
- Netherlands Institute for Neuroscience3
- Center for Basics in NeuroModulation (NeuroModulBasics)2
- Department of Clinical2
- Department of Clinical and Experimental Medicine2
- Department of Clinical Psychology2
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Sleep initiation and maintenance disorders are characterized by impaired ability to fall asleep or stay asleep. They may occur as a primary disorder or in association with another medical or psychiatric condition. The supplied literature frames this as insomnia disorder, with both nighttime sleep complaints and daytime impairment.
The grounding supports association with other medical or psychiatric conditions, but does not provide a specific causal aetiology for sleep initiation and maintenance disorders as a category. For insomnia disorder specifically, the literature links vulnerability to genetic variants, early life stress, major life events, and brain structure and function. It also suggests that brain circuits regulating emotion and arousal may be more relevant than circadian or homeostatic sleep circuits.
The literature describes impaired sleep initiation and maintenance in terms of altered vulnerability within brain circuits regulating emotion and arousal. It also notes links with stress, anxiety, depression, and broader mental health effects, consistent with a disorder involving both sleep disruption and daytime emotional/cognitive consequences. Actigraphy and polysomnography are discussed as assessment tools, but they are diagnostic rather than mechanistic.
For insomnia disorder, the grounding identifies female sex, genetic variants, early life stress, major life events, and vulnerability related to brain structure and function. Stress, anxiety, depression, and psychological pressure are also repeatedly associated with sleep disruption. The literature also notes comorbidity with other medical or psychiatric conditions.
Cognitive behavioural therapy for insomnia is recommended as first-line treatment for chronic insomnia in adults, including those with comorbidities. The grounding also supports use of sleep questionnaires, diaries, clinical interview, and physical examination for diagnosis, with polysomnography reserved for suspected other sleep disorders or treatment-resistant insomnia. Actigraphy may have a role in differential diagnosis or medical care, but is not recommended for routine evaluation.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.