Buspirone is an azapirone with 5-HT1A partial agonist activity which has demonstrated efficacy in the treatment of generalized
anxiety disorder, commonly referred to as persistent anxiety. In this meta-analysis report, safety results from two studies comparing
buspirone 15 mg twice daily (BID) with
buspirone 10 mg three times daily (TID) in patients with persistent anxiety are presented. In the study protocols, qualified patients completed a 7-day placebo lead-in phase and were randomized to receive
buspirone 30 mg per day, as either a BID or TID regimen, for 6-8 weeks. A total of 289 patients received
buspirone 15 mg BID (n = 144) or 10 mg TID (n = 145) at 15 sites. The incidence of adverse events was similar between the two treatment groups, except for a significantly greater incidence of palpitations in patients receiving
buspirone BID (5%) compared to
buspirone TID (1%). The most frequently reported adverse events for both
buspirone BID- and TID-treated patients were
dizziness,
headache, and
nausea. No appreciable differences between treatments were observed for vital signs, physical exam, ECG, or clinical laboratory results. A change to BID dosing for
buspirone may offer convenience and possibly higher compliance in patients with persistent anxiety without compromising the excellent safety and tolerability profile of the medication.