Efficacy of Adaptol® 500 mg Tablets in Patients with Anxiety and Somatic Symptoms of Anxiety Disorder: A Noninterventional Study

Background: Anxiety disorders, including panic disorder, agoraphobia, specific phobias, and generalized anxiety disorder, are among the most frequent psychiatric conditions in primary care. They often present with somatic symptoms such as dyspnea, palpitations, chest or gastrointestinal discomfort, sweating, or flushing. Adaptol® is a non-benzodiazepine anxiolytic with nootropic properties that modulates the limbic-reticular system, hypothalamic emotional centers, and multiple neurotransmitter systems. This study aimed to assess the association between Adaptol® use and changes in anxiety symptoms, including somatic manifestations, in routine practice. Methods: A noninterventional observational study was conducted in 100 adults diagnosed with anxiety disorders in primary care. All received Adaptol® 500 mg as prescribed. Patients had to have mild-to-moderate anxiety (5–14 points according GAD-7) to be enrolled. Exclusion criteria ruled out individuals with concomitant psychiatric or severe somatic conditions and those with use of other medications or any interventions that could affect the symptoms. Anxiety severity and somatic symptom burden were assessed at baseline and after treatment. Results: Adaptol® treatment was associated with reduction in anxiety and somatic complaints. Improvements were reported in palpitations, chest discomfort, gastrointestinal disturbances, and autonomic symptoms. Greater benefit was observed in male patients, though without significance testing, and in those with severe baseline anxiety, as demonstrated by correlation between GAD-7 scores at baseline and changes after the treatment (r = 0.5). No unexpected adverse events occurred. Conclusions: In this real-world study, Adaptol® showed anxiolytic efficacy and good tolerability, improving both psychological and somatic manifestations of anxiety disorders. These findings support its use in primary care, especially in severe cases of anxiety. Controlled trials are needed to support these results.