Abstract
Objectives This prospective, observational, single-arm, open-label study aimed to evaluate the efficacy and safety of a phytotherapeutic and nutraceutical compound in the treatment of patients with insomnia disorder (ID) associated with anxiety. Methods The study was conducted on a clinical sample of 28 patients (6 men, 21.4%, and 22 women, 78.6%) suffering from ID, associated with a state of anxiety. The sample study was clinically evaluated at baseline (T0) and after four (T1) and eight weeks (T2) of phytotherapeutic and nutraceutical treatment using the following self-administered questionnaires: Pittsburgh Sleep Quality Index, State and Trait Anxiety Inventory, Insomnia Severity Index, Depression and Anxiety Scale Short Form - 21, Beck Depression Inventory, Fatigue Severity Scale, Rapid Stress Assessment, Patient Global Impression of Improvement - Severity and short form-36. Results The effect of treatment over time was statistically significant for all measures considered including the short form-36 subscales 3 and 5, with the exception of the other short form-36 subscales and fatigue severity scale. Linear regression reported a significant association only between T1 and T2 scores (p<0.05). No correlations were found with age except for the test short form-36 subscale 5 (Pearson r=0.421; p =0.036 and tau Kendal =0.311; p=0.033) and no correlation for the level of education. No safety concerns were reported in the sample study. Conclusion The results of this study support the clinical efficacy and safety of the phytotherapeutic and nutraceutical study compound for the treatment of ID in patients with anxiety symptoms.