LUNESTA
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 ).
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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
ProIndications & Usage
FDA Label (PDF)LUNESTA ® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). LUNESTA is indicated for the treatment of insomnia. LUNESTA has been shown to de...
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.