Efficacy and safety of dasotraline in attention-deficit hyperactivity disorder: A systematic review and meta-analysis

Pharmacotherapeutic options for attention-deficit hyperactivity disorder (ADHD) are limited due to adverse effects and inadequate efficacy of existing drugs. Clinical trials were conducted on dasotraline in search of a safer and more efficacious alternatives to stimulant agents. This meta-analysis was conducted to evaluate the efficacy and safety of dasotraline in ADHD compared to placebo. The reviewers extracted data from five relevant clinical trials after a literature search on Medline/PubMed, Embase, Scopus, Google Scholar, and Cochrane databases and Clinical Trial Registries. Quality assessment was done using the risk of bias assessment tool, and the random-effects model was used to estimate the effect size. Sub-group analysis, meta-regression, and sensitivity analysis were done as applicable. PRISMA guidelines were followed in the selection, analysis, and reporting of findings. Dasotraline significantly reduced the ADHD total symptom score (SMD: -0.35; 95% CI: -0.55 to -0.15; < 0.001), hyperactivity/impulsivity subscale score (SMD: -0.27; 95% CI: -0.44 to -0.11; = 0.001), inattentiveness sub-scale score (SMD: -0.33; 95% CI: -0.53 to -0.14; < 0.001), and CGI-S (SMD: -0.25; 95% CI: -0.42 to -0.08; = 0.003). Sub-group analysis showed a significant reduction of ADHD symptoms in both pediatric and adult age groups. Meta-regression showed a significant association between SMD of ADHD symptom score reduction and the duration of dasotraline therapy. The incidence of decreased appetite showed dose dependence but not the incidence of insomnia. Dasotraline 4 mg (in children) and 6 mg (in adults) can improve the clinical outcome in patients with ADHD by improving symptoms and global functioning with acceptable tolerability.PROSPERO Registration number: CRD42022321979.