New Treatments & Clinical Trials for Insomnia

Insomnia — difficulty falling or staying asleep — affects roughly one in three adults and when chronic becomes a significant driver of poor mental and physical health. The good news is that effective non-drug treatments exist and newer sleep medications offer options with fewer next-day side effects.

What's actually going on in research

Cognitive behavioral therapy for insomnia (CBT-I) is the most evidence-based treatment but access is limited, so digital CBT-I programs are being validated as scalable alternatives in large trials. A newer class of sleep medications called dual orexin receptor antagonists — which block the wake-promoting orexin system rather than sedating the brain broadly — is being compared with older sleep aids. Researchers are also exploring precision approaches that match treatment to insomnia subtypes based on whether the problem is primarily with falling asleep, staying asleep, or early waking.

What to know before you search

Eligibility requires chronic insomnia diagnosis (typically at least 3 nights/week for 3 months), specifies comorbid conditions, and often requires a run-in sleep diary.

What types of trials are currently open

• Drug trials — Testing new sleep medications or comparing existing agents for safety and effectiveness in different insomnia types.
• Behavioral therapy trials — Evaluating CBT-I delivery formats including digital, group, and brief primary care versions.
• Comorbid insomnia trials — Testing insomnia treatment in people with depression, chronic pain, or other conditions that disturb sleep.
• Device trials — Evaluating wearable sleep trackers and neurostimulation devices for sleep improvement.
• Observational studies — Tracking how insomnia develops, persists, and affects long-term health outcomes.