Sustained therapeutic benefits of unani interventions in primary insomnia: clinical outcomes, biomarker modulation, and relapse analysis

Primary insomnia is a common sleep–wake disorder characterized by impaired sleep initiation and maintenance with associated daytime dysfunction, while current pharmacological treatments are often limited by safety and tolerability concerns. This study examined the independent and combined effects of a sensory-mediated non-pharmacological intervention using Viola odorata L. and an oral botanical preparation derived from Papaver somniferum L. seeds in adults with primary insomnia. This exploratory, prospective, randomized, three-arm, component-based integrative trial enrolled 90 participants aged 18–65 years, randomized equally to Viola odorata –based Natūl therapy, Papaver somniferum seed powder, or combination therapy and treated for four weeks. Sleep outcomes—including Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), daytime dysfunction (VAS), and number of nocturnal awakenings—were assessed at baseline and post-intervention and analysed using a per-protocol framework with non-parametric methods. Recurrence rate has been assessed after three months of treatment. All three interventions were associated with significant improvements across all sleep parameters (all p < 0.001), with large within-group effect sizes (r ≈ 0.86 – 0.89). Between-group comparisons of change scores demonstrated significantly greater improvements with combination therapy compared with either monotherapy (η 2 ≈ 0.21–0.26). Viola odorata –based Natūl monotherapy produced improvements comparable to oral Papaver somniferum therapy for most outcomes. No clinically meaningful safety concerns were observed. Sensory-mediated therapy using Viola odorata L. and oral administration of Papaver somniferum L. seeds are effective in the management of primary insomnia, with combination therapy providing additive sustained with less recurrence rate and supporting a graded, personalized integrative treatment approach.