Wednesday, July 8, 2026

Drug profile · INN

solriamfetol

solriamfetol (SUNOSI) is an FDA-listed pharmaceutical active ingredient. Current US regulatory status: approved.

FDA: approved EMA: approved NMPA: clinical trials Nervous system (N06) N06BA14
US status approved
Patents linked 20
Pipeline programs 14
News articles 0
Drug details — solriamfetol
US status
approved
Class
Nervous system (N06)
Route
Patents
20
Programs
14
Data quality
0.83

Quick answer

solriamfetol (SUNOSI) is an FDA-listed pharmaceutical active ingredient. Current US regulatory status: approved.

Key facts

INN solriamfetol
Brand SUNOSI
Therapeutic class Nervous system (N06)
Formulation TABLET
ATC code N06BA14

Approval history

Authority Status Date
FDA approved
EMA approved
NMPA clinical trials

Pipeline programs

  1. FET Phase 3 · Disc Medicine · ACTH-dependent hypercortisolism
  2. SOL-BED-303 Phase 3 · Axsome Therapeutics · Binge-Eating Disorder
  3. Solriamfetol Phase 3 · Ignis Therapeutics (Suzhou) · Sleep Apnea, Obstructive
  4. Solriamfetol 150 MG Phase 3 · Axsome Therapeutics · Major Depressive Disorder With Excessive Daytime Sleepiness
  5. Solriamfetol 150 mg Phase 3 · Axsome Therapeutics · Excessive Sleepiness
  6. Solriamfetol 150 mg Phase 3 · Axsome Therapeutics · ADHD
  7. Solriamfetol 150 mg Phase 3 · Axsome Therapeutics · Binge-Eating Disorder
  8. Solriamfetol 300 mg Phase 3 · Axsome Therapeutics · Major Depressive Disorder

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)

Related patents

  1. US 12318362

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon May 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12263145

    Methods of administering solriamfetol to lactating women

    Expires Mon Mar 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12194016

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon Jan 09 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12102609

    Methods of administering solriamfetol to lactating women

    Expires Mon Sep 26 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 12090126

    Methods of administering solriamfetol to lactating women

    Expires Mon Sep 12 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 12064411

    Methods of administering solriamfetol to lactating women

    Expires Mon Aug 15 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 12036194

    Methods of administering solriamfetol to lactating women

    Expires Mon Jul 11 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 12005036

    Methods of administering solriamfetol to lactating women

    Expires Mon Jun 06 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11986455

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon May 16 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11986454

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon May 16 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 11969404

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon Apr 25 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 11872204

    Methods of administering solriamfetol to lactating women

    Expires Mon Jan 11 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 11872203

    Methods of administering solriamfetol to lactating women

    Expires Mon Jan 11 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 11857528

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon Dec 28 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 11850226

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon Dec 21 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 11850228

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon Dec 21 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 11850227

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon Dec 21 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 11839599

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon Dec 07 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 11839598

    Methods of providing solriamfetol therapy to subjects with impaired renal function

    Expires Mon Dec 07 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 11793776

    Methods of administering solriamfetol to lactating women

    Expires Mon Oct 19 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is solriamfetol?

solriamfetol (SUNOSI) is an FDA-listed pharmaceutical active ingredient. Current US regulatory status: approved.

What is the brand name for solriamfetol?

SUNOSI is a marketed brand name for solriamfetol. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of solriamfetol?

solriamfetol has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.