Two medicines, side by side
Buspirone vs diazepam
Buspirone and diazepam are both labeled for anxiety. Drugs@FDA records approvals of buspirone since 1986 and of diazepam since 1963. Pharmacies paid $0.043 per buspirone HCl 15 mg tablet and $0.0283 per diazepam 10 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the diazepam label carries a boxed warning.
Check it at the source: the buspirone FDA label on DailyMed (effective December 22, 2023); the diazepam FDA label on DailyMed (effective August 11, 2026).
Highlights of the buspirone record
Buspirone (Buspar) · label of December 22, 2023
Used for
From the label: indicationsBuspirone hydrochloride tablets, USP are 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. […]
On the market
- Earliest approval on file
- September 29, 1986
- Generic labelers
- 47 labelers
- Pharmacy cost
- $0.043 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 10
Highlights of the diazepam record
Diazepam (Valium) · label of August 11, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Used for
From the label: indicationsValium is indicated for the management of anxiety disorders or for 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. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. […]
On the market
- Earliest approval on file
- November 15, 1963
- Generic labelers
- 45 labelers
- Pharmacy cost
- $0.0283 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Buspirone label of December 22, 2023, Diazepam label of August 11, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do buspirone and diazepam differ on the record?
Only the diazepam label carries a boxed warning.
Half-life, in each label's words: Buspirone, “The average elimination half-life of unchanged buspirone after single doses of 10 mg to 40 mg is about 2 to 3 hours.”; Diazepam, “The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours.”
Generics: buspirone since 2001; diazepam since 1985 (Drugs@FDA).
DEA schedule: buspirone none; diazepam CIV.
| Buspirone | Diazepam | |
|---|---|---|
| Labeled for | Anxiety | Anxiety, Muscle spasms and spasticity |
| Pharmacologic class | n/a | Benzodiazepine |
| How it works (label) | n/a | n/a |
| Half-life (label) | The average elimination half-life of unchanged buspirone after single doses of 10 mg to 40 mg is about 2 to 3 hours. | The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours. |
| Earliest approval on file (Drugs@FDA) | September 29, 1986 | November 15, 1963 |
| First generic approved | March 28, 2001 | September 4, 1985 |
| Generic labelers (NDC) | 47 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.043 per tablet (Buspirone HCl 15 mg tablet) | $0.0283 per tablet (Diazepam 10 mg tablet) |
| 12-month price change | -9% | -5% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 10 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 10,970 | 121,010 |
| DEA schedule | none | CIV |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Buspirone label, drug interactionsDiazepam After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C max, AUC, and C min ) were observed for diazepam, but increases of about 15% were seen for nordiazepam, and minor adverse clinical effects (dizziness, headache, and nausea) were observed.
Source: FDA drug labels via openFDA
What do the labels say about using others of their kind?
Buspirone label, warningsSerotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs, SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue) …
Diazepam label, drug interactionsCentrally Acting Agents If Valium is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of Valium, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines …
Source: FDA drug labels via openFDA
What next?
- Alternatives to buspirone
- every medicine labeled for the same conditions