Meta‐analysis of the safety and tolerability of two dose regimens of buspirone in patients with persistent anxiety

Abstract

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.

Efficacy of the 5‐HT1A Agonist, Buspirone Hydrochloride, in Migraineurs With Anxiety: A Randomized, Prospective, Parallel Group, Double‐Blind, Placebo‐Controlled Study

“…We used treatment period of 6 weeks based on the previous 6‐week buspirone trial studies in generalized anxiety disorder (GAD) 29,30 . As noted in the IHS guidelines, however, only the effects of sufficient duration (at least 3 months) are clinically relevant.…”

Dizziness produced by a potent 5HT1A receptor agonist (eptapirone) is not due to postural hypotension

“…Dizziness or light-headedness is a side effect reported commonly with 5HT 1A agonist drugs with an incidence of up to 20-80% (Driver et al 1995;Sramek et al 1999;Robinson et al 2003), far exceeding the reported incidences after other psychotropic drugs. It is often assumed that because this dizziness is worse on standing, it is caused by postural hypotension.…”

Psychopharmacology in supportive care of cancer: a review for the clinician

“…The initial dose is 5 mg two to three times daily, which may be progressively increased up to 30 mg daily. Such side effects as dizziness, headache, and nausea are usually transient and subside as treatment continues [89]. Buspirone has been shown to stimulate respiration experimentally [36,58] and in patients with lung disease [23].…”