Insomnia is a sleep disorder characterized by persistent difficulty falling or staying asleep, often resulting in daytime impairment or distress. It affects approximately 10–30% of the global population, with a higher prevalence in older adults, where insomnia symptoms range from 30% to 48%. The current treatment landscape includes benzodiazepines, melatonin receptor agonists, and antihistamines, but there remains a high unmet clinical need for more effective therapies. Pipeline growth in insomnia drug candidates, driven by advancements in neurobiology and pharmacology, holds promise for novel treatments, especially as the focus on improving sleep quality and minimizing side effects intensifies in the coming years.
The Insomnia Drug Pipeline Insight Report by Expert Market Research gives comprehensive insights into insomnia therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for insomnia. The insomnia report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The insomnia pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with insomnia treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to insomnia.
Insomnia is a sleep disorder where individuals struggle with falling asleep, staying asleep, or waking up too early. It can be acute or chronic and is often caused by stress, anxiety, depression, medications, or underlying health conditions. Disrupted sleep results in daytime fatigue, mood disturbances, and impaired cognitive function, affecting overall well-being.
Insomnia treatments include behavioral therapies like cognitive behavioral therapy for insomnia (CBT-I), which focuses on improving sleep habits. Medications such as benzodiazepines, melatonin agonists, and sedative antihistamines are also utilized but should be prescribed carefully to prevent dependence or side effects.
Insomnia affects 10–30% of the global population, with estimates reaching 50-60%. Chronic insomnia disorder affects approximately 10% of adults in the United States, while 30-50% report experiencing insomnia symptoms. In the United Kingdom, about one in three individuals are affected, and in India, the prevalence ranges from 13.8% to 33%. These statistics highlight the increasing demand for effective treatments in the insomnia drug pipeline.
This section of the report covers the analysis of insomnia drug candidates based on several segmentations, including:
By Phase
By Drug Class
By Route of Administration
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a significant share of the total insomnia clinical trials.
The drug molecule categories covered under the insomnia pipeline analysis include small molecules, peptides, monoclonal antibodies, and gene therapies. The insomnia report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for insomnia.
The EMR report for the insomnia drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed insomnia therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in insomnia clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for insomnia. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of insomnia drug candidates.
The Phase 3 study sponsored by Merck Sharp & Dohme LLC aims to evaluate the efficacy and safety of Suvorexant for treating insomnia in participants with opioid use disorder. The study will assess how well Suvorexant helps individuals fall and stay asleep compared to a placebo. It is expected to be completed by October 2026, with approximately 300 participants.
The Phase 2 study, sponsored by Idorsia Pharmaceuticals Ltd., aims to assess the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of Daridorexant in pediatric subjects aged 10 to under 18 years with insomnia disorder. The study, expected to enroll around 150 participants, is anticipated to be completed by April 2025, providing critical data on the drug’s potential for treating insomnia in this population.
The clinical study, sponsored by Shanghai Haiyan Pharmaceutical Technology Co., Ltd., aims to evaluate the pharmacodynamic and pharmacokinetic interactions between YZJ-1139 tablets and escitalopram oxalate tablets in healthy subjects. The study will also observe the safety of the combined treatment. It is expected to be completed by January 2025 and will involve approximately 24 participants.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Insomnia Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for insomnia. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into insomnia collaborations, regulatory environments, and potential growth opportunities.
Chronic Insomnia Epidemiology Forecast
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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Australia
63 Fiona Drive, Tamworth, NSW
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India
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+91-723-689-1189
Philippines
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+63-287-899-028, +63-967-048-3306
United Kingdom
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+44-753-713-2163
Vietnam
193/26/4 St.no.6, Ward Binh Hung Hoa, Binh Tan District, Ho Chi Minh City
+84-865-399-124
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