Study Comparing Inhaled and Oral Melatonin for Treating Insomnia in Adults Aged 55 and Older

What this Trial Is About

Researchers are evaluating a new inhaled form of melatonin compared to oral melatonin tablets in adults aged 55 and older who have insomnia. The trial aims to understand if inhaled melatonin affects sleep patterns, such as how quickly participants fall asleep, differently than oral tablets. This is an early phase 1, randomized open-label crossover study conducted to explore these potential differences in sleep quality and neuroinflammation markers. Participants will receive two treatments in different periods inhaled melatonin delivered by a pressurized inhaler at a dose of 100 micrograms two puffs nightly for two weeks, and oral melatonin tablets at a dose of 4 mg two tablets nightly for two weeks. After each treatment period, there is a one-week washout before crossing over to the other treatment. The study includes overnight stays in a sleep laboratory for sleep monitoring and blood collection visits to assess biomarkers. During the study, participants will visit the research center five times for screening, overnight sleep studies at the start of each treatment period, and blood collection after each treatment. They will complete daily sleep diaries to record their sleep quality during the two-week treatment periods. Researchers will measure sleep onset latency primarily and also assess sleep time, wakefulness after sleep onset, insomnia severity, and subjective sleep quality. Safety and adherence will be monitored throughout the study, which is expected to end in May 2026.

A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study