Home Health Addyi: Uses, Side Effects, Dosages, Interactions – Verywell Health

Addyi: Uses, Side Effects, Dosages, Interactions – Verywell Health

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Mary Choy, PharmD, is board-certified in geriatric pharmacotherapy and is an active leader in professional pharmacy associations.
Options are limited for medications for treating low sex drive in women. Addyi (flibanserin) is one of only two medications currently approved by the U.S. Food and Drug Administration (FDA) for treating female hypoactive sexual desire disorder (HSDD). Addyi is a non-hormonal pill indicated for premenopausal women only.
The use of this drug remains controversial, mostly due to its potential drug interactions and side effects. In addition, according to various studies, Addyi leads to a minimal to moderate benefit in increasing sexually satisfying events per month.
This makes some experts question whether Addyi is worth the risk and effort (it requires daily use for it to work). The Food and Drug Administration is currently "evaluating the need for regulatory action" after the potential signal of a serious risk was identified as drug hypersensitivity.

Addyi is intended for women who have not yet gone through menopause and are experiencing hypoactive (low) sexual desire regardless of their sexual partner, activity, or situation.
HSDD is a sexual dysfunction disorder that involves a reduction or absence of sexual interest that lasts six or more months. It was renamed female sexual interest/arousal disorder in the Diagnostic and Statistical Manual of Mental Disorders, or DSM-5).
This disorder causes distress or interpersonal difficulties and is unattributable to another health concern (e.g., diabetes or depression), medication (e.g., antidepressants), or relationship challenges.
Due to the complexity of HSDD (there is often more than one contributing factor) and to avoid potential side effects and drug interactions (reviewed below), Addyi is usually considered when other therapies, like seeing a sex therapist, have been first thoroughly explored.
Addyi is believed to bind to serotonin receptors in the central nervous system, becoming an agonist (activator) on 5-HT1A receptors and an antagonist (blocker) on 5-HT2A receptors.
Of particular note, Addyi works on neurotransmitters, which are brain chemicals. As a result of its action in the brain, dopamine and norepinephrine levels may increase, while serotonin levels decrease. The net effect may be improved sexual desire.
As an aside, and to avoid confusion, Addyi should not be considered “female Viagra.” Viagra works by increasing blood flow to the genitals in order to enhance sexual performance. Addyi works in the brain and does not enhance sexual performance.
While there is scientific evidence that Addyi works, the benefit is considered minimal to moderate by experts. In one study, over 1000 premenopausal women with HSDD were randomized to take either Addyi once at bedtime or a placebo drug for 24 weeks.
Compared to the placebo group, the women who took Addyi had a larger increase in their number of satisfying sexual events per month (2.5 on average with Addyi versus 1.5 for placebo). They also had an increase in sexual desire and a decrease in distress related to sexual dysfunction.
In a large review study that analyzed nearly six thousand women, both premenopausal and postmenopausal, when compared to placebo, Addyi was found to result in small increases in sexual desire, as well as a small increase (one-half per month) of satisfying sexual events.
Prior to starting Addyi, it's important to talk to your healthcare provider about any medical conditions you have. In particular, be sure to mention if you:
Avoid driving or operating machinery for at least six hours after you take Addyi, and until you know how this medicine will affect you. Your reactions could be delayed.
If you have liver problems or take any of the following medications (strong or moderate CYP3A4 inhibitors), you should not take Addyi.
HIV medications
Orally-administered fungal infections
Antibiotics
Hepatitis C medications
Other
If you need to take one of the above medications, however:
It's also recommended that patients not take Addyi with the following drugs because they can substantially reduce the levels of Addyi in the blood:
As always, be sure to only start and stop a medication under the guidance of your personal healthcare provider.
Since it's unknown if Addyi can harm an unborn baby, it should be avoided in pregnancy. Likewise, since it's unknown if Addyi can pass into breast milk, a woman should not take Addyi if she is nursing.
Addyi comes in the form of a pink tablet that is taken by mouth. It's important to follow your prescriber's instructions exactly.
According to its label, patients should take one 100 milligram (mg) tablet per day at bedtime. If a dose is missed, the patient should take the next dose at bedtime the following day. The patient should not double the next dose.
If an improvement in symptoms is not noted after eight weeks, the medication should be discontinued (under the guidance of your healthcare provider).
Common side effects associated with Addyi include:
These side effects may be worsened by taking multiple other drugs (called weak CYP3A4 inhibitors) at the same time. Examples of these drugs include:

Tell your doctor about all your current medications and any you start or stop using. Many drugs can interact, and some drugs should not be used together. Addyi can cause low blood pressure and fainting. This risk can be increased when combined with moderate or strong CYP3A4 inhibitors, which is why these drugs are contraindicated or, if absolutely necessary, carefully prescribed and monitored.
But other classes of medications may also increase the risk of low blood pressure and fainting. Though they are not contraindicated, it’s important to be aware of the potential for these effects:
Taking Addyi within two hours of drinking alcohol also increases the risk of severe low blood pressure and fainting. Therefore, women are advised to discontinue drinking alcohol at least two hours prior to taking Addyi at bedtime or to skip their Addyi dose that evening if three or more alcoholic beverages are consumed.
Then, after taking Addyi at bedtime, patients should not use alcohol until the following day.
Keep in mind—low blood pressure and loss of consciousness are possible side effects even if you don't drink alcohol or take other medications or supplements. If you do lose consciousness, seek medical attention right away.
Women are advised to also avoid drinking grapefruit juice if they are taking Addyi. Finally, Addyi can cause sedation or sleepiness, and this risk is increased with alcohol and certain medications.
As a result of possible sedation, patients are advised not to drive, operate machinery, or engage in activities that require clear thinking until at least six hours after taking Addyi.
If you are suffering from a low sexual desire that is associated with stress, it is important to see your healthcare provider for a full evaluation. While Addyi may be a treatment option for you, your healthcare provider may suggest that you try other therapies first—ones that are perhaps safer and more directly target the cause behind your low sex drive.
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T. S. Sathyanarayana Rao and Chittaranjan Andrade. Flibanserin: Approval of a controversial drug for a controversial disorder. Indian J Psychiatry. 2015;57(3): 221–223. doi:10.4103/0019-5545.166630
Food and Drug Administration. Potential signals of serious risks/new safety information identified by the FDA adverse event reporting system.
Food and Drug Administration. Addyi medication guide.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
U.S. National Library of Medicine. National Center for Biotechnology Information. Flibanserin.
Baid R, Agarwal R. Flibanserin: A controversial drug for female hypoactive sexual desire disorder. Ind Psychiatry J. 2018 Jan-Jun; 27(1): 154–157. doi:10.4103/ipj.ipj_20_16
Katz M et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med. 2013 Jul;10(7):1807-15. doi:10.1111/jsm.12189
Jaspers L, Feys F, Bramer WM, Franco OH, Leusink P, Laan ET. Efficacy and safety of flibanserin for the treatment of hypoactive sexual desire disorder in women: A systematic review and meta-analysis. JAMA Inter Med. 2016;176(4):453-62. doi:10.1001/jamainternmed.2015.8565
Gellad WF, Flynn KE, Alexander GC. Evaluation of Flibanserin: Science and Advocacy at the FDA. JAMA. 2015 Sep 1;314(9):869-70. doi:10.1001/jama.2015.8405
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Terrier C & Terrier JE. [Efficacy and safety of flibanserin "new female Viagra®?": Literature review]. Prog Urol. 2016 Sep-Oct;26(11-12):592-599. doi:10.1016/j.purol.2016.08.016

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