Efficacy and safety of traditional Chinese medicine aromatherapy for insomnia patients with predominant difficulty in sleep initiation

Abstract Background Insomnia is highly prevalent, and non‐pharmacological strategies to facilitate sleep initiation remain an important clinical priority. Aims This study aimed to evaluate the tolerability, safety, and preliminary sleep‐related effects of a herbal aromatherapy liquid administered using a Traditional Chinese Medicine Aromatherapy Sleep Aid Device (TCMASAD) in adults with insomnia predominantly characterized by difficulty initiating sleep. Materials and Methods This single‐center, single‐arm pre–post pilot study enrolled 30 adults with insomnia. Participants received a 4‐week home‐based aromatherapy intervention. Outcomes were assessed using the Pittsburgh Sleep Quality Index (PSQI), daily sleep diaries, and overnight polysomnography (PSG). Results Within‐subject comparisons showed reductions in total PSQI scores and six of seven PSQI component scores after the intervention (all p < 0.01), suggesting improved subjective sleep quality. PSG further showed reductions in sleep‐onset latency and the number of nocturnal awakenings ( p < 0.05). The intervention was generally well tolerated, and no serious adverse events were reported. Discussion These preliminary findings suggest that a 4‐week intervention with herbal aromatherapy liquid delivered via a TCMASAD is feasible, well tolerated, and associated with improvements in sleep initiation and overall sleep quality in adults with insomnia characterized by difficulty falling asleep. Conclusion Herbal aromatherapy delivered through the TCMASAD may represent a feasible and acceptable non‐pharmacological approach for insomnia management. Controlled trials are warranted to confirm efficacy and establish comparative effectiveness.