How to Get Addyi (Flibanserin) in Hawaii

What Is Flibanserin and Why Does It Require a Special Process?

Flibanserin is the only FDA-approved non-hormonal medication for acquired, generalized HSDD in premenopausal women. The FDA approved it in August 2015 under a Risk Evaluation and Mitigation Strategy (REMS) because of a clinically significant interaction between flibanserin and alcohol that can produce severe hypotension and syncope. That REMS program, called the Addyi REMS, requires every prescriber and dispensing pharmacy to complete specific training and certification before flibanserin is prescribed or dispensed. [1]

The BEGONIA trial (published in the Journal of Sexual Medicine, N=1,378) showed that flibanserin 100 mg at bedtime produced a statistically significant increase in satisfying sexual events compared with placebo over 24 weeks, with a mean increase of 0.8 to 1.0 satisfying sexual events per month above baseline (P<0.001). [2] Across the three key Phase 3 trials submitted to the FDA, the drug reduced distress scores on the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) by roughly 11 to 13 points versus 8 to 10 points for placebo. [1]

The drug works centrally: it is a 5-HT1A agonist and 5-HT2A antagonist with modest dopamine D4 agonism, shifting the neurotransmitter balance that governs sexual motivation. It is not a hormone. It does not raise testosterone. That distinction matters for patients in Hawaii who may also be evaluating testosterone therapy or estrogen-based options for low libido. [3]

Step 1, Confirm You Meet the FDA-Approved Indication

Addyi is approved for premenopausal women only. The FDA label specifies "acquired, generalized hypoactive sexual desire disorder." Acquired means the condition was not lifelong. Generalized means it occurs in most sexual situations, not only with one partner or in one context. [1]

Before your appointment, review your symptom timeline. A clinician will likely use the Decreased Sexual Desire Screener (DSDS), a four-item validated tool, or the Female Sexual Function Index (FSFI) desire subscale to confirm the diagnosis formally. A score of 5 or below on the FSFI desire subscale is commonly cited as a threshold consistent with clinically meaningful low desire, though individual clinical judgment applies. [4]

Women who are postmenopausal, who have another primary sexual dysfunction (e.g., pain-predominant dyspareunia), or whose low desire is better explained by a relationship issue, another medication (e.g., SSRIs), or a thyroid disorder may not qualify under the approved indication. Your provider will screen for those factors during the visit. [3]

Step 2, Find a REMS-Certified Provider in Hawaii

Hawaii law permits telehealth prescribing of controlled and non-controlled substances, including flibanserin, provided the prescribing encounter is synchronous audio-video. Flibanserin is not a scheduled substance under the federal Controlled Substances Act, which means no in-person DEA-mandated examination is required. [5]

Any of the following license types may prescribe flibanserin in Hawaii after completing REMS certification:

• Medical doctors (MD) and doctors of osteopathic medicine (DO) licensed by the Hawaii Medical Board
• Advanced practice registered nurses (APRN) with prescriptive authority under Hawaii Revised Statutes Chapter 457
• Physician assistants (PA) supervised or collaborating with a licensed physician per Hawaii Revised Statutes Chapter 453

The Addyi REMS program website maintains a searchable directory of certified prescribers. [6] Telehealth platforms with REMS-certified clinicians who hold active Hawaii licenses can conduct your full intake visit over video, review labs, and send the prescription electronically to a REMS-certified pharmacy that ships to Hawaii addresses.

HealthRX Hawaii Access Framework for Flibanserin:

1. Confirm premenopausal status and acquired, generalized symptom pattern.
2. Identify a REMS-certified prescriber licensed in Hawaii (telehealth or in-person).
3. Complete alcohol-use screening (AUDIT-C) before or during the visit.
4. Order baseline labs if the prescriber identifies hepatic risk factors.
5. Enroll in the Addyi REMS patient acknowledgment (done at the pharmacy, not the prescriber).
6. Select a REMS-certified pharmacy that ships to your island.
7. Verify insurance or cash-pay pricing; apply the Sprout Pharmaceuticals savings card if eligible.

Step 3, Labs and Screening Required Before the Prescription

Routine liver function testing is not mandated by the FDA label for every patient, but it is required if you have known hepatic impairment. The label explicitly contraindicates flibanserin in patients with hepatic impairment of any severity because plasma levels of the drug rise dramatically when liver metabolism (primarily CYP3A4) is impaired. [1]

For most healthy premenopausal women with no liver disease history, many REMS-certified providers will prescribe after a clinical interview alone. However, if you drink alcohol regularly, have a history of hepatitis, fatty liver disease, or use CYP3A4 inhibitors (e.g., fluconazole, oral contraceptives containing CYP3A4-inhibiting progestins, or grapefruit juice in large amounts), a full metabolic panel including ALT, AST, alkaline phosphatase, and total bilirubin is appropriate before prescribing. [7]

The most clinically important pre-prescription screening step is the alcohol-use assessment. The REMS program requires the prescriber to counsel patients that combining flibanserin with alcohol, even moderate amounts, can cause syncope and severe hypotension. The FDA label states that in a dedicated alcohol interaction study, the rate of hypotension/syncope events with flibanserin plus alcohol was 4 of 23 subjects compared with 0 of 23 subjects taking placebo plus alcohol. [1] Patients must agree to abstain from alcohol during treatment.

Baseline hormone labs (FSH, estradiol, testosterone) are not required by the REMS but are commonly ordered to rule out premature ovarian insufficiency or an androgen abnormality as the primary driver of low desire, since those conditions would require different treatment approaches. [8]

Step 4, The Telehealth Visit: What to Expect

A typical telehealth intake for flibanserin in Hawaii runs 20 to 40 minutes. The provider will:

Review your full sexual and medical history, including onset of low desire, relationship context, presence of distress (distress is required for diagnosis), current medications, and contraceptive method. They will administer or ask you to complete a validated symptom scale such as the FSFI or the DSDS. [4]

Screen for contraindications. Strong CYP3A4 inhibitors are absolutely contraindicated with flibanserin. The FDA label lists fluconazole as a drug that raises flibanserin plasma exposure by roughly 7-fold. [1] The provider will ask about azole antifungals, certain antibiotics (e.g., clarithromycin), and HIV protease inhibitors. Moderate CYP3A4 inhibitors require caution and dose-timing discussion.

Document your alcohol-use pattern using the AUDIT-C. A score of 3 or above in women typically warrants further discussion before prescribing. [9]

Provide the REMS counseling, which includes the mandatory patient education about alcohol avoidance, the risks of CNS depression, and the instruction to take the drug only at bedtime. The patient acknowledgment form is signed at the pharmacy step, not during the provider visit itself, under the current REMS structure. [6]

Write and transmit the electronic prescription to your chosen REMS-certified pharmacy.

Step 5, Choosing a Pharmacy in Hawaii

Hawaii has both retail pharmacy chains and independent 503A compounding pharmacies that are licensed to dispense or compound flibanserin for individual patients. A 503A compounding pharmacy may prepare a customized formulation (e.g., a lower dose or an alternative delivery form) for a patient when a prescriber determines the commercially available product does not meet a specific clinical need. [10]

For the branded Addyi 100 mg tablet, only REMS-certified pharmacies may dispense. The REMS-certified pharmacy list is available on the Addyi REMS program website. [6] Mail-order pharmacies that ship to Hawaii islands (including neighbor islands such as Maui, Kauai, and the Big Island) are an option; typical shipping time from a mainland-based mail-order pharmacy to Hawaii is 3 to 7 business days via USPS Priority or UPS Ground (converted to air for Hawaii routes).

Local Honolulu-area pharmacies affiliated with major chains may also carry Addyi if they have completed REMS certification. Call ahead to confirm REMS status and stock before presenting your prescription.

Cash-pay pricing for branded Addyi without insurance runs approximately $800 to $900 for a 30-tablet supply (30-day supply at one tablet per night) as of early 2025. Sprout Pharmaceuticals offers a savings card that may reduce out-of-pocket cost to $99 per month for commercially insured patients and may offer reduced pricing for cash-pay patients who qualify. Check the manufacturer's patient support line at 1-844-ADDYI-411 for current program terms.

Hawaii Medicaid (Med-QUEST) does not cover flibanserin as of 2025. Patients enrolled in Med-QUEST should expect to pay out of pocket or pursue a prior authorization appeal, though successful appeals for flibanserin under Med-QUEST are uncommon given the current non-coverage policy.

Prior Authorization for Commercial Insurance Plans in Hawaii

Even if your commercial plan lists flibanserin on formulary, most Hawaii-based plans (including HMSA, Kaiser Permanente Hawaii, and Ohana Health Plan) impose prior authorization (PA) requirements. A PA for flibanserin typically requires:

Prescriber documentation: Confirmation of premenopausal status, the DSM-5 or ICD-10 diagnosis code for HSDD (F52.0), symptom duration of at least 6 months, evidence that low desire causes marked distress or interpersonal difficulty, and documentation that secondary causes (thyroid dysfunction, medication side effects, relationship factors) have been assessed. [11]

Step therapy: Some plans require a trial of a psychotherapeutic intervention (e.g., cognitive behavioral therapy for sexual dysfunction) or a trial of addressing any contributing medication (e.g., SSRI dose reduction or switch) before approving flibanserin. The American College of Obstetricians and Gynecologists (ACOG) acknowledges that combined pharmacotherapy and psychotherapy may be more effective than either alone, but does not require psychotherapy as a prerequisite for prescribing. [12]

Denial and appeal: If a PA is denied, your provider can submit a peer-to-peer request with the plan's medical director. Citing the FDA-approved indication, the validated symptom scale score, the absence of contraindications, and the fact that flibanserin is the only FDA-approved non-hormonal HSDD treatment strengthens the appeal. A published analysis in the Journal of Women's Health noted that access barriers for FDA-approved women's sexual health treatments remain disproportionate compared with analogous men's treatments, which may support an equity-based appeal argument. [13]

Efficacy, Safety, and What to Tell Your Hawaii Provider at Follow-Up

Patients who respond to flibanserin typically notice improvement within 4 to 8 weeks, though the FDA label and the key trials used 24-week endpoints. If there is no meaningful improvement in satisfying sexual events and no reduction in distress by week 8, the label recommends discontinuation. [1]

The most common adverse effects reported in the Phase 3 program were dizziness (11.4% flibanserin vs. 2.2% placebo), somnolence (11.2% vs. 3.0%), nausea (10.4% vs. 3.8%), and fatigue (9.2% vs. 5.6%). [1] These effects are generally dose-timing related and are minimized by taking the drug at bedtime rather than earlier in the evening.

At your 4-week and 8-week follow-up visits (which can also be conducted via telehealth), bring or report:

• Your FSFI desire subscale score or your own estimate of satisfying sexual events per month
• Any episodes of dizziness, somnolence, or near-syncope
• Any changes in alcohol use
• Any new medications started, particularly azole antifungals or antibiotics

The Endocrine Society's Clinical Practice Guideline on female sexual dysfunction notes that HSDD is the most common female sexual disorder, affecting an estimated 8 to 10 percent of women of reproductive age in the United States, and recommends that treatment decisions be individualized. [14] That guideline is a useful document to reference during your consultation if your provider is less familiar with HSDD pharmacotherapy.

Transferring an Existing Prescription to Hawaii

If you are relocating to Hawaii from another state and already have an active flibanserin prescription, the process depends on the dispensing format:

Retail pharmacy transfer: A REMS-certified retail pharmacy in Hawaii (or a mail-order REMS pharmacy shipping to Hawaii) can accept a transferred prescription from another REMS-certified pharmacy in another state, provided the original prescription still has refills remaining and the prescribing provider holds an active license. Hawaii pharmacy law does not prohibit interstate prescription transfers for non-controlled substances. [15]

New prescription required: If your original prescriber is not licensed in Hawaii, you will need a new prescribing encounter with a Hawaii-licensed provider. A telehealth platform with Hawaii-licensed clinicians can complete this in a single visit.

Records to bring: Prior lab results (metabolic panel, hormone levels), your current medication list, and any documentation of prior PA approvals will speed up the new-provider onboarding.

Compounding Flibanserin in Hawaii via 503A Pharmacies

A 503A compounding pharmacy in Hawaii may legally prepare a customized flibanserin formulation when a licensed prescriber writes a patient-specific prescription indicating a clinical need that the commercial product cannot meet. Examples of clinical justifications include an allergy to an inactive ingredient in the Addyi tablet, a swallowing difficulty requiring a suspension, or a dose modification. [10]

Compounded flibanserin is not subject to the Addyi REMS because REMS requirements attach to the FDA-approved branded product, not to compounded preparations of the same active pharmaceutical ingredient. This means a 503A-compounded flibanserin product may be dispensed by a non-REMS pharmacy. Patients should understand, though, that compounded preparations do not carry the FDA approval or the post-market safety data of the branded product. [16]

The American Society for Reproductive Medicine (ASRM) has published position statements supporting individualized care for female sexual dysfunction, including access to compounded preparations when clinically appropriate, though ASRM does not specifically endorse compounded flibanserin over the branded version. [17]