LUNESTA (eszopiclone)
LUNESTA is indicated for the treatment of Insomnia.
How LUNESTA Works
The exact mechanism of action for eszopiclone as a hypnotic is unclear; however, its effect is believed to be related to its interaction with GABA-receptor complexes. It targets binding domains located close to or allosterically coupled to benzodiazepine receptors, which is thought to mediate its sedative effects.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-12-15
- Routes
- ORAL
- Dosage Forms
- TABLET
LUNESTA Approval History
What LUNESTA Treats
1 indicationsLUNESTA is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
LUNESTA Boxed Warning
COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of LUNESTA. Some of these events may result in serious injuries, including death. Discontinue LUNESTA immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning . Comple...
WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of LUNESTA. Some of these events may result in serious injuries, including death. Discontinue LUNESTA immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning . Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of LUNESTA. Some of these events may result in serious injuries, including death. Discontinue LUNESTA immediately if a patient experiences a complex sleep behavior ( 4 , 5.1 ).
LUNESTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LUNESTA
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07332442 CALM-OSA | 2000040345 1R01HL179077-01 | Ph 3 | recruiting | Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea |
| NCT03668041 NAP | 2016 | Ph 3 | completed | National Adaptive Trial for PTSD Related Insomnia |
| NCT03937713 PRECEPT-D results posted | NURB-008-18F | Ph 4 | completed | Effectiveness of Combining Behavioral and Pharmacologic Therapy for Complex Insomnia in Veterans With PTSD |
| NCT04875364 ExPRESSION | 201432 | Ph 2 | recruiting | Do Endotypes Predict Response and Sequelae in OSA Patients |
| NCT04639193 RESCUE-Combo results posted | 191990 | Ph 2 | completed | Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea |
| NCT02456532 CIS2 results posted | #9384 | Ph 4 | completed | Safety and Efficacy of Chronic Hypnotic Use 2 |
| NCT01605253 results posted | 1R34MH091338-01A1 1R34MH091338-01A1 | Ph 4 | completed | Eszopiclone for the Treatment of Posttraumatic Stress Disorder |
| NCT01887691 | 2012P000187 | Ph 1 | terminated | Sleep Effectiveness and Insulin and Glucose Homeostasis |
| NCT00857220 results posted | 190-247 | Ph 3 | completed | Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia |
| NCT00616655 results posted | 194-027 | Ph 2 | completed | Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects |
| NCT00724282 results posted | 15632 ESRC-124 | Ph 4 | completed | Treatment of Insomnia and Glucose Metabolism |
| NCT01100164 Eszo | EF097 | Ph 3 | completed | A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia |
| NCT00893269 | NA_00017909 R21DA025794 | Ph 1 | completed | The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep |
| NCT00856973 results posted | 190-246 | Ph 3 | completed | Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia |
| NCT00612157 CPAPASAP | WRAMC07-17022 | Ph 4 | completed | Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LUNESTA FDA Label Details
Indications & Usage
FDA Label (PDF)LUNESTA is indicated for the treatment of Insomnia.
WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of LUNESTA. Some of these events may result in serious injuries, including death. Discontinue LUNESTA immediately if a patie...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment