"Feb. 27, 2012 -- A provocative new study finds that people who take prescription sleeping pills -- even once in a while -- have a higher death risk than non-users.
The top third of sleeping-pill users had a 5.3-fold higher death risk."...
- Patient Information:
Details with Side Effects
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).
DOSAGE AND ADMINISTRATION
Use the lowest effective dose for the patient.
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 LUNESTA 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]. The total dose of LUNESTA should not exceed 3 mg, once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS].
Geriatric Or Debilitated Patients
The total dose of LUNESTA should not exceed 2 mg in elderly or debilitated patients.
Patients With Severe Hepatic Impairment, Or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered LUNESTA with potent CYP3A4 inhibitors, the total dose of LUNESTA should not exceed 2 mg [see WARNINGS AND PRECAUTIONS].
Use With CNS Depressants
Dosage adjustments may be necessary when LUNESTA is combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS].
Administration With Food
Taking LUNESTA with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of LUNESTA on sleep latency [see CLINICAL PHARMACOLOGY].
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 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side.
LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side.
Storage And Handling
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
LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side, and are supplied as:
NDC 63402-191-10 bottle of 100 tablets
LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side, and are supplied as:
NDC 63402-190-30 bottle of 30 tablets
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA 01752 USA. Revised: 5/2014.
Last reviewed on RxList: 5/29/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Lunesta Information
Lunesta - User Reviews
Lunesta User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.