What FDA-approved medications are available to treat female sexual dysfunction, specifically hypoactive sexual desire disorder (HSDD)?

FDA-Approved Medications for Female Sexual Dysfunction

For premenopausal women with hypoactive sexual desire disorder (HSDD), flibanserin is the first-line FDA-approved medication, with bremelanotide as an alternative FDA-approved option, while ospemifene is FDA-approved specifically for dyspareunia in postmenopausal women. 1

First-Line Treatment Options for HSDD

• Flibanserin (Addyi) 100 mg daily at bedtime is FDA-approved for premenopausal women with HSDD, with modest efficacy of approximately 1 additional satisfying sexual event every 2 months compared to placebo 1, 2
• Bremelanotide is FDA-approved for premenopausal women with HSDD and is used as a self-administered subcutaneous injection as needed 1
• Clinical trials demonstrate that flibanserin significantly improves sexual desire (measured by FSFI desire domain score), reduces sexual distress, and increases satisfying sexual events compared to placebo 3, 4

Important Safety Considerations for Flibanserin

• Flibanserin carries risk of severe low blood pressure and fainting, especially when combined with alcohol 2
• After taking flibanserin at bedtime, patients should not drink alcohol until the following day 2
• Common adverse events include dizziness (9.6%), somnolence (8.6%), insomnia (6.2%), and nausea (5.7%) 5
• Flibanserin is contraindicated with moderate or strong CYP3A4 inhibitors and in patients with liver problems 2

Treatment Option for Dyspareunia

• Ospemifene is FDA-approved specifically for dyspareunia in postmenopausal women but is not indicated for HSDD 1, 6
• Ospemifene is contraindicated in women with a history of estrogen-dependent cancers 1, 6

Efficacy Considerations

• Meta-analyses show that flibanserin treatment results in approximately one-half additional satisfying sexual event per month while significantly increasing the risk of adverse events 7
• The efficacy of flibanserin in postmenopausal women has been demonstrated in clinical trials, though it is currently only FDA-approved for premenopausal women 8
• Women's mean global impression of improvement scores with flibanserin indicated minimal improvement to no change in some studies 7

Treatment Algorithm

1. For premenopausal women with HSDD:

   • First-line: Flibanserin 100 mg daily at bedtime 1, 2
   • Alternative: Bremelanotide as needed (subcutaneous injection) 1

2. For postmenopausal women with dyspareunia:

   • Consider ospemifene if no history of estrogen-dependent cancers 1, 6

3. For women with contraindications to FDA-approved options:

   • Consider non-pharmacological approaches including psychological counseling and mechanical options 1

Monitoring and Follow-up

• Monitor for adverse effects, particularly dizziness, somnolence, and fatigue 3, 5
• Advise patients taking flibanserin to avoid activities requiring full alertness until at least 6 hours after taking the dose 2
• Evaluate treatment efficacy based on improvement in sexual desire, reduction in distress, and increase in satisfying sexual events 3, 4