Buspirone Side Effects
Buspirone is generally well-tolerated with the most common side effects being dizziness, nausea, headache, nervousness, and lightheadedness, occurring in approximately 3-12% of patients. 1
Most Common Side Effects
The FDA-approved drug label identifies the following most frequently reported adverse events in controlled clinical trials 1:
- Dizziness (12%) - the most common side effect 1
- Drowsiness (10%) 1
- Nausea (8%) 1
- Headache (6%) 1
- Nervousness (5%) 1
- Lightheadedness (3%) 1
- Excitement (2%) 1
Gastrointestinal Effects
Buspirone commonly causes GI disturbances 1:
Cardiovascular Effects
Central Nervous System Effects
Beyond the common effects listed above, additional CNS effects include 1:
- Insomnia (3%) 1
- Decreased concentration (2%) 1
- Confusion (2%) 1
- Depression (2%) 1
- Dream disturbances (frequent) 1
Discontinuation Rates
Approximately 10% of patients discontinued buspirone during premarketing trials due to adverse events 1. The primary reasons for discontinuation were 1:
- CNS disturbances (3.4%) - primarily dizziness, insomnia, nervousness, drowsiness, lightheadedness 1
- GI disturbances (1.2%) - primarily nausea 1
- Miscellaneous (1.1%) - primarily headache and fatigue 1
Rare but Serious Adverse Events
While uncommon, clinicians should be aware of potentially serious effects 1:
- Movement disorders - rare cases of persistent dystonia, tremors, and exacerbation of tardive dyskinesia have been reported 2
- Seizures (rare, <1/1,000 patients) 1
- Suicidal ideation (infrequent, 1/100 to 1/1,000 patients) 1
- Hallucinations (infrequent) 1
Important Clinical Considerations
Buspirone lacks the sedative, muscle relaxant, and anticonvulsant properties of benzodiazepines 3. This translates to 4, 3:
- Minimal sedation compared to benzodiazepines 4
- No psychomotor impairment when combined with alcohol or given alone 4
- No abuse potential, dependence, or withdrawal symptoms reported 4, 3
Onset and Tolerability
Buspirone requires 2-4 weeks to become effective for anxiety management 5. The frequency of adverse effects is generally low, and most side effects are mild 4. Meta-analysis data confirms that buspirone maintains an excellent safety and tolerability profile across different dosing regimens 6.
Laboratory Abnormalities
Infrequent laboratory changes include 1: