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insomnia — Treatment Landscape & Competitive Intelligence

insomnia (disease) competitive landscape: 10 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

10 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating insomnia, deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Quviviq DARIDOREXANT Idorsia Orexin Receptor Antagonist [EPC] Orexin receptor type 1 2022-01-01
Dayvigo LEMBOREXANT Eisai Orexin Receptor Antagonist [EPC] Orexin receptor type 2 2019-01-01
Lunesta ESZOPICLONE Waylis eszopiclone Gamma-aminobutyric acid receptor subunit alpha-1 2004-01-01
Imovane ZOPICLONE Sunovion Pharms Inc zopiclone GABA A receptor alpha-5/beta-2/gamma-2 2004-01-01
Noctan METHYPRYLON Roche methyprylon GABA-A receptor alpha-1/beta-3/gamma-2 1982-01-01
Valmid ETHINAMATE Dista ethinamate 1982-01-01
Prazene PRAZEPAM Parke Davis GABA-A receptor alpha-1/beta-2/gamma-2 1982-01-01
Metabarbital METHARBITAL AbbVie metharbital GABA-A receptor; anion channel 1982-01-01
Glimid GLUTETHIMIDE Sandoz GABA-A receptor alpha-1/beta-3/gamma-2 1976-01-01
Nembutal Sodium PENTOBARBITAL Oak Pharms pentobarbital GABA-A receptor alpha-1/beta-2/gamma-2 1973-01-01

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

  1. · 18 drugs in insomnia
  2. AbbVie · 2 drugs in insomnia
  3. Brooke Army Medical Center · 1 drug in insomnia
  4. Dista · 1 drug in insomnia
  5. Eisai · 1 drug in insomnia
  6. Idorsia · 1 drug in insomnia
  7. Johnson & Johnson (McNeil Consumer Healthcare) · 1 drug in insomnia
  8. Mallinckrodt · 1 drug in insomnia
  9. National Institute on Drug Abuse (NIDA) · 1 drug in insomnia
  10. Oak Pharms · 1 drug in insomnia
  11. Parke Davis · 1 drug in insomnia
  12. Professional Complementary Health Formulas · 1 drug in insomnia

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Every new regulatory action, PDUFA date, or trial completion in insomnia:

Cite this brief

Drug Landscape (2026). insomnia — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/insomnia. Accessed 2026-06-10.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing