Insomnia Disorder
5
Pipeline Programs
3
Companies
4
Clinical Trials
1 recruiting
1
Approved Products
Pipeline by Development Stage
Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
0
0
3
1
Early DiscoveryClinical DevelopmentMarket
On Market (1)
Approved therapies currently available
E
Competitive Landscape
3 companies ranked by most advanced pipeline stage
VP
Trial Timeline
Clinical trial activity over time
2021
2022
2023
2024
2025
2026
2027
2028
Vanda PharmaceuticalsTasimelteon Oral Suspension
Nxera PharmaDaridorexant
Eisailemborexant
EisaiLemborexant 5 mg
Clinical Trials (4)
Total enrollment: 1,460 patients across 4 trials
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Start: Apr 2025Est. completion: Jan 2028420 patients
Phase 3Recruiting
A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder
Start: Dec 2024Est. completion: Oct 2025
Phase 3Completed
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
Start: Nov 2016Est. completion: Jan 2019971 patients
Phase 3Completed
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
Start: Dec 2014Est. completion: Apr 201569 patients
Phase 1Completed
Phase Legend
Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available
Key Insights
3 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 1,460 patients
3 companies competing in this space