Eszopiclone 2 mg/1
Eszopiclone · TABLET, FILM COATED · Proficient Rx LP
Eszopiclone is a tablet, film coated containing eszopiclone at 2 mg/1, taken oral. Manufactured by Proficient Rx LP.
Key Facts
- Brand Name
- Eszopiclone
- Generic Name
- Eszopiclone
- NDC Code (Product)
82804-076- Manufacturer
- Proficient Rx LP
- Strength
- 2 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA091166
- Marketing Start
- 04/15/2014
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: Related Substances
Aidapak Services, LLC
Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.
Macleods Pharma Usa Inc
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE 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 )
Dosage & Administration
2 DOSAGE & ADMINISTRATION Use the lowest effective dose for the patient. • Use the lowest dose effective for the patient ( 2 ) • Recommended initial dose is 1 mg, immediately before bedtime, with at least 7 to 8 hours remaining before the planned time of awakening. May increase dose if clinically indicated, to a maximum of 3 mg ( 2.1 ) • Geriatric or debilitated patients: Dose should not exceed 2 mg ( 2.2 ) • Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg ( 2.3 ) • Do not take with or immediately after a meal ( 2.5 ) 2.1 Dosage in Adults The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone tablets following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [ see Warnings and Precautions (5.1) ]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [ see Warnings and Precautions (5.6) ]. 2.2 Geriatric or Debilitated Patients The total dose of eszopiclone tablets should not exceed 2 mg in el…
Contraindications
4 CONTRAINDICATIONS • Eszopiclonetablet is contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets [see Warnings and Precautions (5.1) ]. • Eszopiclone tablet is 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 tablets ( 4 ) • Known hypersensitivity to eszopiclone ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • 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 tablets ( 7.2 ) • Ketoconazole Combination use increases exposure and effect of eszopiclone tablets. Dose reduction of eszopiclone tablet 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. The exposure of eszopiclone was increased by coadministration of ketoconazole, a potent inhibitor of CYP3A4. Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly. Dose reduction o…
Adverse Reactions
6 ADVERSE REACTIONS 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. The premarketing development program for eszopiclone tablets included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in c…
Frequently Asked Questions
What is Eszopiclone used for?
Eszopiclone contains Eszopiclone. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Eszopiclone a controlled substance?
Yes, Eszopiclone is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Eszopiclone?
The generic name for Eszopiclone is Eszopiclone. There are 1 other brand versions of Eszopiclone.
What is the NDC code for Eszopiclone 2 mg/1?
The NDC (National Drug Code) for Eszopiclone 2 mg/1 is 82804-076, listed by Proficient Rx LP.