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Last reviewed 2026-06-10 · How we verify

Disorders of initiating and maintaining sleep — Treatment Landscape & Competitive Intelligence

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

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

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

Marketed treatment landscape

Approved drugs treating Disorders of initiating and maintaining sleep, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	First approval
Melatol	MELATONIN	Rad Neurim Pharmaceuticals Eec Sarl	Adrenocorticotropic Hormone [EPC]	Melatonin receptor type 1B	2007-01-01
Sonata	ZALEPLON	Pfizer	gamma-Aminobutyric Acid A Receptor Agonist [EPC]	GABA-A receptor alpha-1/beta-2/gamma-2	1999-01-01
Circadin	Circadin	Neurim Pharmaceuticals Ltd.		Cytochrome P450 1B1, Myeloperoxidase, Nuclear receptor ROR-alpha

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

Neurim Pharmaceuticals Ltd. · 1 drug in Disorders of initiating and maintaining sleep
Pfizer · 1 drug in Disorders of initiating and maintaining sleep
Rad Neurim Pharmaceuticals Eec Sarl · 1 drug in Disorders of initiating and maintaining sleep

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Cite this brief

Drug Landscape (2026). Disorders of initiating and maintaining sleep — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/disorders-of-initiating-and-maintaining-sleep. Accessed 2026-06-10.

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