BuSpar is indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The efficacy of BuSpar has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and BuSpar relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows:

Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:

1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, fur-rowed brow, strained face, fidgeting, restlessness, easy startle.
2.  Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4. Vigilance and scanning: hyper attentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.

The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.

The effectiveness of BuSpar in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with BuSpar for 1 year without ill effect. Therefore, the physician who elects to use BuSpar for extended periods should periodically reassess the usefulness of the drug for the individual patient.

The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed.

The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.

When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS: DRUG INTERACTIONS section should be followed.

BuSpar® (buspirone hydrochloride tablets, USP) Tablets, 5 mg and 10 mg (white, ovoid-rectangular with score, MJ logo, strength and the name BuSpar embossed) are available in bottles of 100 and 500.

5-mg tablets

NDC 0087-0818-41                Bottles of 100
NDC 0087-0818-44                Bottles of 500

10-mg tablets

NDC 0087-0819-41                Bottles of 100
NDC 0087-0819-44                Bottles of 500

Tablets, 15 mg white, in the DIVIDOSE® tablet design imprinted with the MJ logo, are available in bottles of 60 and 180. Tablets, 30 mg pink, in the DIVIDOSE® tablet design imprinted with the MJ logo, are available in bottles of 60. The 15-mg and 30-mg tablets are scored so that they can be either bisected or trisected. The 15-mg tablet has ID number 822 on one side and on the reverse side, the number 5 on each trisect segment. The 30-mg tablet has ID number 824 on one side and on the reverse side, the number 10 on each trisect segment.

15-mg tablets

NDC 0087-0822-32                 Bottles of 60
NDC 0087-0822-33                 Bottles of 180

30-mg tablets

NDC 0087-0824-81                 Bottles of 60

US Patent No. 5,015,646

Store at Room Temperature—Protect from temperatures greater than 86º F (30º C). Dispense in a tight, light-resistant container (USP).

REFERENCE

1. American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders—III, American Psychiatric Association, May 1980.

Bristol-Myers Squibb Company Princeton, NJ 08543 USA
Revised November 2003
FDA rev date: 2/7/2002

Bookmark this page: