Insomnia
Sleep 2 original drugsSleep indication. Insomnia has 2 FDA-approved novel treatments, led by EISAI INC, with 58 active industry clinical trials across 7 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.
Insomnia Market Leaders
Companies with the most FDA-approved novel Insomnia drugs.
Phase 3 Readouts Pro
4 active Phase 3 trials with confidence-graded completion dates.
Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.
Insomnia Treatments by Mechanism
Top 5 mechanisms across 20 industry trials with a known mechanism of action.
MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.
Insomnia Clinical Pipeline by Phase
124 industry-sponsored trials across 57 sponsors
Novel Insomnia Drugs by Company (New molecular entities)
2 companies have an FDA-approved novel drug for Insomnia.
Reformulations (9 drugs) Click to expand
Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.
Insomnia Drug Targets
Molecular targets of approved and investigational Insomnia drugs — 7 targets tracked.
Generic Drugs (7 ANDA approved) Click to expand
Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).
Drug Categories:
- Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
- Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
- Biosimilars: BLA-approved biologics highly similar to reference products
- Generics: ANDA-approved copies of small molecule drugs