Provigil FDA Approval Status (2026) – Approved or Not?
FDA Regulatory Database

Is Provigil
FDA approved?

DrugStatusIndex.com provides a plain-English status page for Provigil, including FDA approval status, prescription classification, compounding context, pricing information, and regulatory notes.

FDA Approved for non-sexual indications; sexual performance use is off-label or adverse-effect related
FDA status
Neuropsychiatric / Libido-Related Search Term
Drug category
May 2026
Last reviewed
Drug status summary

Provigil

FDA Approved for non-sexual indications; sexual performance use is off-label or adverse-effect related

Provigil is included because some neuropsychiatric medications are searched in connection with libido, arousal, sexual side effects, or off-label sexual wellness questions.

Brand names
Provigil
Prescription status
Prescription only
Compounded status
Generally not a compounding-first sexual performance product.
Confusion level
Medium
FDA Approved Approved for commercial use in the US
Not Approved Not cleared by FDA for use
Investigational Under review or in clinical trials
Rx Only Prescription required — not OTC
FDA approval status

Provigil approval status and regulatory context

This page is structured for LPagery Pro and uses your CSV fields to create a consistent, scalable drug-status page that matches the current DrugStatusIndex.com home page design.

What DrugStatusIndex currently shows

Provigil is included because some neuropsychiatric medications are searched in connection with libido, arousal, sexual side effects, or off-label sexual wellness questions.

Regulatory note: FDA approval, where applicable, is for labeled indications other than sexual enhancement unless specifically stated.
FDA status
FDA Approved for non-sexual indications; sexual performance use is off-label or adverse-effect related
Drug category
Neuropsychiatric / Libido-Related Search Term
Prescription status
Prescription only
Availability note
Available by prescription for approved indications; sexual wellness use requires clinician oversight.

Index review fields

Review status
Ready for LPagery import; editorial/FDA verification recommended before publication
Last checked
May 4, 2026
Published
No
Page URL
https://drugstatusindex.com/is-provigil-fda-approved/
Pricing and access

Provigil pricing information

Pricing can vary by dose, pharmacy, insurance coverage, manufacturer savings, coupon programs, market availability, and current supply conditions.

Retail estimate
$1,200-$1,500 brand / month

Estimated cash or retail pricing range when available.

Coupon estimate
$25-$75 generic modafinil

Discount-card or pharmacy coupon estimate when available.

Pricing last checked
May 2026

Pricing data should be rechecked before making financial or treatment decisions.

Pricing summary

Provigil estimated cash pricing: $1,200-$1,500 brand / month. Discount/coupon estimate: $25-$75 generic modafinil. Pricing varies by dose, quantity, pharmacy, location, insurance, and current savings programs.

Coverage and savings notes

Manufacturer savings: Manufacturer or patient-assistance savings may apply for brand/specialty products; generic drugs usually rely on pharmacy coupon pricing.

Insurance note: Coverage and prior authorization vary by plan, dose, pharmacy, and diagnosis.

Sources and verification

Verify Provigil directly with trusted source material

DrugStatusIndex.com is an informational resource. FDA status, availability, and pricing should be independently verified using official FDA resources, pharmacy data, prescribing information, and licensed healthcare guidance.

FDA / regulatory source
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
Pricing source
https://www.goodrx.com/provigil

Preview this drug-status page

Use this button to preview the generated LPagery page for Provigil and confirm the page output before wider publishing.

Preview Page →
Informational resource only
DrugStatusIndex.com reflects publicly available FDA regulatory data and does not provide medical advice, diagnosis, treatment recommendations, pharmacy recommendations, or legal/regulatory advice. Always consult a licensed healthcare provider before making any medical decision.
Scroll to Top