How many drugs treat Initial insomnia?

Drug Landscape tracks 4 marketed treatments for Initial insomnia (deduplicated by molecule). 0 Phase 3 candidates and 0 Phase 2 candidates are in the pipeline.

How do I subscribe to ongoing alerts?

Subscribe to /feed/disease/initial-insomnia.xml in Feedly / Inoreader. Every regulatory action, PDUFA date, or trial completion in this treatment area lands in your feed automatically.

Last reviewed 2026-06-10 · How we verify

Initial insomnia — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Initial insomnia (disease) competitive landscape: 4 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

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

Marketed treatment landscape

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

Drug	Generic	Sponsor	Class	Target	First approval
Rozerem	RAMELTEON	Takeda	Melatonin Receptor Agonist [EPC]	Melatonin receptor type 1A	2005-01-01
Sonata	ZALEPLON	Pfizer	gamma-Aminobutyric Acid A Receptor Agonist [EPC]	GABA-A receptor alpha-1/beta-2/gamma-2	1999-01-01
Ambien	zolpidem	Sanofi		α1 subunit containing GABA A receptors
Rozerem	Rozerem	Northwestern University		Melatonin receptor type 1A, Melatonin receptor type 1B

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

Northwestern University · 1 drug in Initial insomnia
Pfizer · 1 drug in Initial insomnia
Sanofi · 1 drug in Initial insomnia
Takeda · 1 drug in Initial insomnia

Subscribe to ongoing alerts

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

Cite this brief

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

Initial insomnia full disease profile — treatment pathway, diagnostics, guidelines
Browse all CI briefs
Build a custom feed

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