LUNESTA Coated tablet (2020)

Βιβλιογραφική αναφορά

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Sunovion Pharmaceuticals Inc.

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BOXED WARNING SECTION

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 ...

1. Indications and Usage

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. ...

2. Dosage and Administration

Use the lowest effective dose for the patient. 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 ...

3. Dosage Forms and Strengths

LUNESTA is available in 1 mg, 2 mg and 3 mg strengths for oral administration. LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side. LUNESTA ...

4. Contraindications

LUNESTA is contraindicated in patients who have experienced complex sleep behaviors after taking LUNESTA [see Warnings and Precautions (5.1)]. LUNESTA is contraindicated in patients with known ...

5. Warnings and Precautions

5.1 Complex Sleep Behaviors Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any subsequent use of ...

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 ...

6.1. Clinical Trials Experience

Adverse Reactions Resulting in Discontinuation of Treatment In placebo-controlled, parallel-group clinical trials in the elderly, 3.8% of 208 patients who received placebo, 2.3% of 215 patients who received ...

6.2. Postmarketing Experience

In addition to the adverse reactions observed during clinical trials, dysosmia, an olfactory dysfunction that is characterized by distortion of the sense of smell, has been reported during postmarketing ...

7. Drug Interactions

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: ...

8.1. Pregnancy

Risk Summary Available pharmacovigilance data with LUNESTA use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. ...

8.2. Lactation

Risk Summary There are no data on the presence of eszopiclone in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits ...

8.4. Pediatric Use

Safety and effectiveness of LUNESTA have not been established in pediatric patients. LUNESTA failed to demonstrate efficacy in controlled clinical studies of pediatric patients with Attention-Deficit/Hyperactivity ...

8.5. Geriatric Use

A total of 287 subjects in double-blind, parallel-group, placebo-controlled clinical trials who received eszopiclone were 65 to 86 years of age. The overall pattern of adverse events for elderly subjects ...

8.6. Hepatic Impairment

No dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. Exposure was increased in severely impaired patients compared with healthy volunteers. The dose of LUNESTA should ...

9. Drug Abuse and Dependence

9.4 Tolerance Some loss of efficacy to the hypnotic effect of benzodiazepines and benzodiazepine-like agents may develop after repeated use of these drugs for a few weeks. No development of tolerance ...

9.1. Controlled Substance

LUNESTA is a Schedule IV controlled substance under the Controlled Substances Act. Other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. ...

9.2. Abuse

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for nonmedical purposes, often in combination with other psychoactive ...

9.3. Dependence

The clinical trial experience with LUNESTA revealed no evidence of a serious withdrawal syndrome. Nevertheless, the following adverse events included in DSM-IV criteria for uncomplicated sedative/hypnotic ...

10. Overdosage

In clinical trials with eszopiclone, one case of overdose with up to 36 mg of eszopiclone was reported in which the subject fully recovered. Since commercial marketing began, spontaneous cases of eszopiclone ...

11. Description

LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-6(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] ...

12.1. Mechanism of Action

The mechanism of action of eszopiclone as a hypnotic is unclear; however, its effect could be related to its interaction with GABA-receptor complexes at binding domains located close to or allosterically ...

12.3. Pharmacokinetics

The pharmacokinetics of eszopiclone have been investigated in healthy subjects (adult and elderly) and in patients with hepatic disease or renal disease. In healthy subjects, the pharmacokinetic profile ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In a carcinogenicity study in rats, oral administration of eszopiclone for 97 (males) or 104 (females) weeks resulted in no increases in tumors; plasma levels (AUC) of eszopiclone at the ...

14. Clinical Studies

The effect of LUNESTA on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18-86) with chronic and transient insomnia in six placebo-controlled ...

16.1. How Supplied

LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side, and are supplied as: NDC 63402-193-10 bottle of 100 tablets NDC 63402-193-03 bottle of ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

See FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with LUNESTA. Inform patients of the availability of a Medication Guide ...