Research Article| Volume 19, ISSUE 3, P498-506, May 1997

Efficacy and safety of two dosing regimens of buspirone in the treatment of outpatients with persistent anxiety

      This paper is only available as a PDF. To read, Please Download here.


      This randomized, double-masked, comparative study evaluated the efficacy and safety of buspirone 30 mg/d, administered twice a day (BID) or three times a day (TID), in patients with generalized anxiety disorder (GAD), commonly called persistent anxiety. Patients who participated had GAD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised, modified to include patients for whom the symptom duration was at least 4 weeks and scored ≥ 18 on the Hamilton Rating Scale for Anxiety (HAM-A). After a 7-day placebo lead-in phase, patients who continued to quality were randomized to receive buspirone, titrated from 15 mg/d (5 mg TID) to 30 mg/d, as either a BID or TID regimen, for 8 weeks. Of the 137 patients who began the study, 120 patients were included in the data evaluation. Both buspirone BID and TID treatment groups demonstrated significant reductions in men HAM-A total scores and improvement on Clinical Global Impression measures, with no significant differences detected between the two tretment groups for either measure at any time point. The overall incidence of adverse events was similar for both treatment groups, except for a significantly greater incidence of amblyopia in patients receiving buspirone 15 mg BID. In summary, there was no appreciable difference in efficacy or safety between buspirone 15 mg BID or 10 mg TID in patients with persistent anxiety.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Clinical Therapeutics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Feighner JP
        • Merideth CH
        • Hendrickson GA
        A double-blind comparison of buspirone and diazepam in outpatients with generalized anxiety disorder.
        J Clin Psychiatry. 1982; 43: 103-107
        • Feighner JP
        • Cohn JB
        Analysis of individual symptoms in generalized anxiety—a pooled, multistudy, double-blind evaluation of buspirone.
        Neuropsychobiology. 1989; 21: 124-130
      1. 50th ed. Physicians' Desk Reference®. Medical Economic Data, Montvale, NJ1996: 737-739 (Buspar®)
        • Cutler NR
        • Sramek JJ
        • Keppel Hesselink JM
        A double-blind placebo-controlled study comparing the efficacy and safety of ipsapirone versus larazepam in patients with generalized anxiety disorder: A prospective multicenter trial.
        J Clin Psychopharmacol. 1993; 13: 429-437
        • Cutler NR
        • Sramek JJ
        • Wardle TS
        • et al.
        The safety and efficacy of ipsapirone versus lorazepam in outpatients with GAD: Single site findings from a multicenter trial.
        Psychopharmacol Bull. 1993; 29: 303-308
        • Cutler NR
        • Keppel Hesselink JM
        • Sramek JJ
        A phase II multicenter dose-finding, efficacy and safety trial of ipsapirone in outpatients with generalized anxiety disorder.
        Prog Neuro-Psychopharmacol Biol Psychiatry. 1994; 18: 447-463
        • Gammans RE
        • Mayol RF
        • Labudde JA
        Metabolism and disposition of buspirone.
        Am J Med. 1986; 80 (Suppl 3B): 41-51
        • Blackwell B
        Drug therapy: Patient compliance.
        NEJM. 1973; 289: 249-252
        • Boyd JR
        • Covington TR
        • Stanaszek WF
        • Coussons RT
        Drug defaulting part I: Determinants of compliance.
        Am J Hosp Pharm. 1974; 31: 362-367
        • Fisher RG
        Compliance-oriented prescribing: Simplifying drug regimens.
        J Fam Pract. 1990; 10: 427-435
        • Greenberg RN
        Overview of patient compliance with medication dosing: A literature review.
        Clin Ther. 1984; 6: 592-599
        • Kaplan HI
        • Sadock BJ
        Anxiety disorders.
        in: 7th ed. Synopsis of Psychiatry: Behavioral Sciences Clinical Psychiatry. Williams & Wilkins, Baltimore, MD1994: 615
        • American Psychiatric Association
        Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised. American Psychiatric Press, Washington, DC1987
        • Hamilton M
        The assessment of anxiety states by rating.
        Br J Med Psychol. 1959; 32: 50-55
        • Hamilton M
        Development of a rating scale for primary depressive illness.
        Br J Soc Clin Psychol. 1967; 6: 278-296
      2. Guy W ECDEU Assessment Manual for Psychopharmacology, Revised. National Institute of Mental Health, Rockville, Md1976: 217-222 (US Department of Health, Education and Welfare Pub. No. (ADM) 76-338)
        • Rickels K
        • Weisman K
        • Norstad N
        Buspirone and diazepam in anxiety: A controlled study.
        J Clin Psychiatry. 1982; 43: 81-86
        • Wheatley D
        Buspirone: Multicenter efficacy study.
        J Clin Psychiatry. 1982; 43: 92-94
        • Zelfelder WG
        Buspirone (Buspar®): A double-blind comparison of two dose regimens.
        J Drug Ther Res. 1990; 15: 112-118
        • Fontaine R
        • Napoliello MJ
        Double-blind comparison of buspirone 10 mg BID versus buspirone 5 mg TID in generalized anxiety disorder.
        Curr Ther Res. 1993; 54: 254-261
        • Böhm C
        • Placchi M
        • Stallone F
        • et al.
        A double-blind comparison of buspirone, clobazam, and placebo in patients with anxiety treated in a general practice setting.
        J Clin Psychopharmacol. 1990; 10 (Suppl 3): 39S-42S
        • Sussman N
        Discussion: The uses of buspirone in psychiatry.
        J Clin Psychiatry. 1994; 12 (Monograph): 20
        • Zung WK
        • Block JE
        • Bryan E
        • et al.
        Management of the Depressed Patient: The Art and Science and Compliance. J Clin Psychiatry. 1982; 1 (Part III: A primary care perspective) (Monograph): 13-18
        • Callahan EJ
        • Alevizos PN
        • Teigen JR
        • et al.
        Behavioral effects of reducing the daily frequency of phenothiazine administration.
        Arch Gen Psychiatry. 1975; 32: 1285-1290
        • Kalyanasundaram S
        • Shrikhande SA
        • Machado TA
        • Kapur RL
        Single daily dose chlorpromazine therapy in psychosis: An evaluation.
        Acta Psychiatr Scand. 1981; 64: 158-166
        • Zaccara G
        • Galli A
        Effectiveness of simplified dosage schedules on the management of ambulant epileptic patients.
        Eur Neurol. 1979; 18: 341-344
        • Terrence C
        • Alberts M
        Phenytoin dosage in ambulant epileptic patients.
        J Neurol Neurosurg Psychiatry. 1978; 41: 463-465
        • Eisen SA
        • Miller DK
        • Woodward RS
        • et al.
        The effect of prescribed daily dose frequency on patient medication compliance.
        Arch Intern Med. 1990; 150: 1881-1884
        • Sramek JJ
        • Cutler NR
        • Seifert RD
        • Luna AD
        Compliance in hypertension: Daily versus twice daily.
        Am J Hypertens. 1993; 6 (Letter): 1063