Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)
Aphena Pharma Solutions - Tennessee, LLC
ESZOPICLONE
ESZOPICLONE 2 mg
ORAL
PRESCRIPTION DRUG
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 contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2)] . There are no adequate and well-controlled studies in pregnant women. Eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg
Eszopiclone tablets are available as follows: Eszopiclone 1 mg tablets are light-blue, film-coated, convex, round tablets, debossed “93” on one side of the tablet and “E7” on the other side, in bottles of 30. NDC 42291-271-30 Eszopiclone 2 mg tablets are white, film-coated, convex, round tablets, debossed “93” on one side of the tablet and “E8” on the other side, in bottles of 90. NDC 42291-272-90 Eszopiclone 3 mg tablets are blue, film-coated, convex, round tablets, debossed “93” on one side of the tablet and “E9” on the other side, in bottles of 90. NDC 42291-273-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
ESZOPICLONE - ESZOPICLONE TABLET, FILM COATED Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE Eszopiclone (ES-zoe-PIK-lone) Tablets, Coated C-IV Read the Medication Guide that comes with eszopiclone tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about eszopiclone tablets? After taking eszopiclone tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with eszopiclone tablets. Reported activities include: • driving a car ("sleep-driving") • making and eating food • talking on the phone • having sex • sleep-walking Call your doctor right away if you find out that you have done any of the above activities after taking eszopiclone tablets. Important: 1. Take eszopiclone tablets exactly as prescribed • Do not take more eszopiclone tablets than prescribed. • Take eszopiclone tablets right before you get in bed, not sooner. 2. Do not take eszopiclone tablets if you: • drink alcohol • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take eszopiclone tablets with your other medicines • cannot get a full night’s sleep WHAT ARE ESZOPICLONE TABLETS? Eszopiclone tablets are a sedative-hypnotic (sleep) medicine. Eszopiclone tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include: • trouble falling asleep • waking up often during the night Eszopiclone tablets are not for children. Eszopiclone tablets are a federally controlled substance (C-IV) because it can be abused or lead read_full_document
ESZOPICLONE - ESZOPICLONE TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESZOPICLONE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESZOPICLONE TABLETS. ESZOPICLONE TABLETS, FOR ORAL USE, CIV INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance (1) DOSAGE AND ADMINISTRATION _Non-Elderly Adults:_ 2 mg starting dose immediately before bedtime. May start or increase to 3 mg if clinically indicated since 3 mg is more effective for sleep maintenance (2.1) _Elderly:_ For difficulty falling asleep 1 mg immediately before bedtime. For difficulty staying asleep 2 mg immediately before bedtime (2.1) _Severe Hepatic Impairment:_ Starting dose 1 mg (2.1) _Patients Taking Concomitant Potent CYP3A4 Inhibitors:_ Do not exceed a 1 mg starting dose. Maximum dose is 2 mg (2.1) Do not take with or immediately after a meal (2.1) DOSAGE FORMS AND STRENGTHS Tablets: 1 mg, 2 mg, and 3 mg (3) CONTRAINDICATIONS Known hypersensitivity to eszopiclone (4) WARNINGS AND PRECAUTIONS _Evaluate for Co-Morbid Diagnoses:_ Reevaluate if insomnia persists after 7 to 10 days of use (5.1) _Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported):_ Do not rechallenge if such reactions occur (5.2) _Abnormal Thinking, Behavioral Changes (e.g., hallucinations, Complex Behaviors (e.g., “sleep-driving”):_ Immediately evaluate if occurs (5.3) _Worsening of Depression or Suicidal Thinking_ may occur: Prescribe the least number of tablets feasible to avoid intentional overdose (5.3, 5.7) _Withdrawal Effects_ (symptoms may occur with rapid dose reduction or discontinuation) (5.4, 9.3) _CNS Depressant Effects:_ Use can impair alertness and motor coordination. If used in combination with other CNS depressants, dose reductions read_full_document