Insomnia Drug Pipeline Analysis Report 2025

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.

Report Coverage

The Insomnia Drug Pipeline Insight Report by the publisher 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 Drug Pipeline Outlook

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 Epidemiology

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.

Insomnia Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of insomnia drug candidates based on several segmentations, including:

By Phase

• Late-Stage Products (Phase 3 and Phase 4)
• Mid-Stage Products (Phase 2)
• Early-Stage Products (Phase I)
• Preclinical and Discovery Stage Products

By Drug Class

• Small Molecules
• Peptides
• Monoclonal Antibodies
• Gene Therapies

By Route of Administration

• Oral
• Parenteral
• Others

Insomnia - Pipeline Assessment Segmentation, By Phases

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 analysis, phase II covers a significant share of the total insomnia clinical trials.

Insomnia - Pipeline Assessment Segmentation, By Drug Classes

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.

Insomnia Clinical Trials Therapeutic Assessment - Competitive Dynamics

The 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:

• Merck Sharp & Dohme LLC
• Idorsia Pharmaceuticals Ltd.
• Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
• Avecho Biotechnology
• Nanjing Chia-tai Tianqing Pharmaceutical
• Sequential Medicine Ltd.
• Janssen Research & Development, LLC
• Axsome Therapeutics, Inc.

Insomnia Emerging Drugs Profile

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.

Drug: Suvorexant

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.

Drug: Daridorexant

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.

Drug: YZJ-1139 Tablets, Escitalopram Oxalate Tablets

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.

Reasons To Buy This 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.

Key Questions Answered in the Insomnia - Pipeline Insight Report

• Which companies/institutions are leading the insomnia drug development?
• What is the efficacy and safety profile of insomnia pipeline drugs?
• Which company is leading the insomnia pipeline development activities?
• What is the current insomnia commercial assessment?
• What are the opportunities and challenges present in the insomnia drug pipeline landscape?
• What is the efficacy and safety profile of insomnia pipeline drugs?
• Which company is conducting major trials for insomnia drugs?
• Which companies/institutions are involved in insomnia collaborations aimed at providing enhanced therapeutic alternatives for patients?
• What are the geographies covered for clinical trials in insomnia?

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