Eszopiclone — Membership Pricing

Related medications

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Also listed for Insomnia

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• Melatonin
• Trazodone
• Zolpidem

Other medications in Sleep Disorders

• Modafinil
• Armodafinil

What Eszopiclone is approved for (FDA label)

Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets 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). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets has been shown to decrease sleep latency and improve sleep maintenance ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: September 10, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Eszopiclone (FDA label)

WARNING: COMPLEX SLEEP BEHAVIORS 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 eszopiclone tablets. Some of these events may result in serious injuries, including death. Discontinue eszopiclone tablets immediately if a patient experiences a complex sleep behavior [ see Contraindications ( 4 ) and Warnings and Precautions (5.1) ]. 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 eszopiclone tablets. Some of these events may result in serious injuries, including death. Discontinue eszopiclone tablets immediately if a patient experiences a complex sleep behavior (4, 5.1).

Source: FDA prescribing information (DailyMed). Set ID: 9dfe774a-2c7a-4e10-bedd-cde64ad28676. SPL document ID: 5b20f7a9-774a-bf90-e063-6294a90a480d. Label effective date: September 10, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Eszopiclone (FDA label)

Eszopiclone tablets, USP are available in 1 mg, 2 mg and 3 mg strengths for oral administration. Eszopiclone tablets, USP 2 mg are are white, round, biconvex, film-coated tablet, debossed with "L 35" on one side and plain on other side. Tablets: 2 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 9dfe774a-2c7a-4e10-bedd-cde64ad28676. SPL document ID: 5b20f7a9-774a-bf90-e063-6294a90a480d. Label effective date: September 10, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Eszopiclone (FDA label)

The following are described in more detail in the Warnings and Precautions section of the label: • Complex Sleep Behaviors [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ] • CNS Depressant Effects and Next-Day Impairment [ see Warnings and Precautions ( 5.2 ) ] • Need to Evaluate for Comorbid Diagnoses [ see Warnings and Precautions ( 5.3 ) ] • Severe Anaphylactic and Anaphylactoid Reactions [ see Warnings and Precautions ( 5.4 ) ] • Abnormal Thinking and Behavioral Changes [ see Warnings and Precautions ( 5.5 ) ] • Withdrawal Effects [see Warnings and Precautions ( 5.6 ) ] • Timing of Drug Administration [see Warnings and Precautions ( 5.7 ) ] • Special Populations [ see Warnings and Precautions ( 5.8 ) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Source: FDA prescribing information (DailyMed). Set ID: 9dfe774a-2c7a-4e10-bedd-cde64ad28676. SPL document ID: 5b20f7a9-774a-bf90-e063-6294a90a480d. Label effective date: September 10, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Eszopiclone (FDA label)

• Eszopiclonetablets are contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets [ see Warnings and Precautions ( 5.1 ) ]. • Eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [ see Warnings and Precautions ( 5.3 ) ]. • Patients who have experienced complex sleep behaviors after taking eszopiclone ( 4 ) • Known hypersensitivity to eszopiclone ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 9dfe774a-2c7a-4e10-bedd-cde64ad28676. SPL document ID: 5b20f7a9-774a-bf90-e063-6294a90a480d. Label effective date: September 10, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Eszopiclone (FDA label)

• CNS Depressant Effects: Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients taking 3 mg dose against driving and against activities requiring complete mental alertness during the morning after use. ( 5.2 ) • Evaluate for Comorbid Diagnoses : Reevaluate if insomnia persists after 7 to 10 days of use ( 5.3 ) • Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur ( 5.4 ) • Abnormal Thinking and Behavioral Changes : Changes including decreased inhibition, bizarre behavior, agitation and depersonalization have been reported.

Source: FDA prescribing information (DailyMed). Set ID: 9dfe774a-2c7a-4e10-bedd-cde64ad28676. SPL document ID: 5b20f7a9-774a-bf90-e063-6294a90a480d. Label effective date: September 10, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Eszopiclone (FDA label)

• CNS Depressants: Additive CNS-depressant effects with combination use. Use with ethanol causes additive psychomotor impairment ( 7.1 ) • Rifampicin: Combination use may decrease exposure and effects of eszopiclone ( 7.2 ) • Ketoconazole: Combination use increases exposure and effect of eszopiclone. Dose reduction of eszopiclone is needed ( 7.2 ) 7.1 CNS Active Drugs Ethanol: An additive effect on psychomotor performance was seen with coadministration of eszopiclone and ethanol [see Warnings and Precautions ( 5.1 , 5.2 )]. Olanzapine: Coadministration of eszopiclone and olanzapine produced a decrease in DSST scores. The interaction was pharmacodynamic; there was no alteration in the pharmacokinetics of either drug. 7.2 Drugs that Inhibit or Induce CYP3A4 Drugs that Inhibit CYP3A4 (Ketoconazole) CYP3A4 is a major metabolic pathway for elimination of eszopiclone.

Source: FDA prescribing information (DailyMed). Set ID: 9dfe774a-2c7a-4e10-bedd-cde64ad28676. SPL document ID: 5b20f7a9-774a-bf90-e063-6294a90a480d. Label effective date: September 10, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.