Why was BuSpar withdrawn? No published source gives the maker's reason. What the regulators do record: in the United States, the FDA found that BuSpar was "not withdrawn from sale for reasons of safety or effectiveness", and in Australia the BuSpar tablets were taken off the register in 2017 at the sponsor's own request. Buspirone, the anxiety medicine in BuSpar, is still made as generic tablets, and a new Australian brand, Anksilon, was registered in January 2025. It is a different medicine from the ones for erectile dysfunction, but it has a link to sex, covered below.
When was BuSpar withdrawn in Australia?
In June 2017. The Therapeutic Goods Administration (TGA) records that BuSpar buspirone 5 mg and 10 mg tablets, sponsored by Aspen Pharma, were cancelled from the Australian Register of Therapeutic Goods with effect from 22 June 2017 (TGA — BuSpar 10 mg; TGA — BuSpar 5 mg). Both entries sit in the TGA's database of "cancellations of Australian Register of Therapeutic Goods entries requested by sponsors" (TGA — cancellations by sponsors). The record gives no reason, and a search of the register for BuSpar today finds nothing.
Why was BuSpar discontinued in the United States?
The FDA's notices say it was not for safety or effectiveness, and do not say what the reason was. BuSpar tablets, from Bristol-Myers Squibb and first approved in 1986, had been moved to the FDA's "Discontinued Drug Product List" by 2010, when the agency found they "were not withdrawn from sale for reasons of safety or effectiveness" (FDA notice, October 2010). For the capsules, Bristol-Myers Squibb asked in December 2012 for the approval to be withdrawn; it ended on 5 January 2015, and in 2023 the FDA found the same: "not withdrawn for reasons of safety or effectiveness" (FDA notice, June 2023). Generic buspirone tablets stayed approved in the US. Neither notice gives the company's commercial reasons.
Is buspirone still available in Australia?
It is registered again. Anksilon buspirone 5 mg and 10 mg tablets, sponsored by Orion Pharma, were entered on the register on 16 January 2025 as a "New generic medicine", for "the short-term treatment of anxiety" (TGA — Anksilon registration), and it is "only available with a doctor's prescription" (Anksilon CMI). Registration does not show whether it is stocked: the TGA's record notes the sponsor declared "$0 turnover" for 2024-25 (ARTG 422890). Your GP or pharmacist can tell you what is available now.
How is buspirone different from other anxiety medicines?
It is not a benzodiazepine, and its label reports no dependence. The Australian product information calls it "not chemically or pharmacodynamically related to benzodiazepines", says it "has shown no potential for drug addiction and dependence based on limited human and animal studies", reports that "No withdrawal reactions have been reported", and adds that it "will not control benzodiazepine withdrawal symptoms" (Anksilon PI). The consumer leaflet still asks you not to stop it without your doctor's advice, as you "may experience some nausea, insomnia, dizziness or mild feelings of sadness", and not to have grapefruit or grapefruit juice (Anksilon CMI). Lorazepam, a benzodiazepine, is compared in does lorazepam cause erectile dysfunction?
Can buspirone affect sex or erections?
Rarely, according to its label. Among the events reported with buspirone, "decreased or increased libido" is uncommon (up to 1 in 100) and "abnormal ejaculation, impotence" rare (up to 1 in 1,000), though for these reports "a causal relationship to buspirone treatment cannot be determined with certainty" (Anksilon PI). In one small early report of 10 people with generalised anxiety disorder, sexual function returned to normal in 8 of 10 after four weeks on buspirone (Othmer and Othmer, 1987). Anxiety itself can affect erections: can anxiety cause erectile dysfunction?
Does buspirone help with sexual side effects of antidepressants?
The trials disagree. Of 117 depressed patients on citalopram or paroxetine, 47 had sexual side effects; about 58% of those given buspirone for four weeks reported better sexual function, against 30% on placebo, and "The difference between placebo and active drug treatment was more pronounced in women than in men" (Landén et al., 1999). In 57 women on fluoxetine, "Neither buspirone nor amantadine was more effective than placebo" (Michelson et al., 2000). For men with erection problems caused by antidepressants, a Cochrane review found that "the addition of sildenafil or tadalafil appears to be an effective strategy" (Taylor et al., 2013). Adding buspirone to an antidepressant is a prescriber's decision: the Anksilon leaflet lists SSRIs such as fluoxetine, paroxetine and sertraline among the medicines that may interfere with it (Anksilon CMI). More in Viagra with antidepressants and anxiety medication.
The short answer
BuSpar's makers have not published why they stopped selling it. The FDA found it was not withdrawn for safety or effectiveness, and in Australia the sponsor asked for the BuSpar tablets to be cancelled in 2017. Buspirone itself is back on the Australian register as Anksilon, on prescription. More questions about who makes medicines are in our guide to production and manufacturers.
