Do your patients
have trouble sleeping? PrLUNESTA®may help
LUNESTA (eszopiclone) is indicated for short-term (usually not exceeding 7-10 days) use for:
- treatment and symptomatic relief of insomnia characterized by difficulty falling asleep
- frequent nocturnal awakenings and/or early morning awakenings
where disturbed sleep results in impaired daytime functioning.
Click here for additional safety information and for a link to the Product Monograph discussing:
- Contraindications in patients with hypersensitivity to this drug or zopiclone, myasthenia gravis, severe respiratory impairment, elderly patients receiving concomitant potent CYP3A4 inhibitors or having severe hepatic insufficiency, patients who have experienced complex sleep-related behaviours after taking LUNESTA or any other hypnotic agent
- The most serious warnings and precautions regarding addiction, abuse, and misuse, withdrawal, risks from concomitant use with opioids, and complex sleep-related behaviours
- Other relevant warnings and precautions regarding the failure of insomnia to remit after 7-10 days, development of tolerance, rebound insomnia, CNS depressant effects and next-day impairment, patient counseling information regarding next-day impairment, falls and fractures, severe anaphylactic and anaphylactoid reactions, anterograde amnesia, psychomotor impairment, alteration in cognitive function, daytime anxiety/restlessness, abnormal thinking and behavioural changes, primary depression, patients with compromised respiratory function, pregnant or nursing women, children below the age of 18, and concomitant use with alcohol and other CNS depressants
- Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions
The Product Monograph is also available at www.healthcanada.gc.ca,
www.sunovion.ca/monographs/lunesta.pdf or by calling 1-866-260-6291.
*Clinical significance has not been established
Mechanism of Action
LUNESTA (eszopiclone) is a non-benzodiazepine hypnotic
agent that acts upon
The effects of eszopiclone are due to modulation of gamma-aminobutyric acid (GABA)-A-receptor macromolecular complexes, containing alpha-1, alpha-2, alpha-3 and alpha-5 sub-units.
This increases chloride conductance resulting in neuronal hyperpolarization, inhibiting neuronal transmission and causing sleep.1
†Clinical significance has not been established.
The Safety Profile and Efficacy of LUNESTA in adults under 65 was evaluated in two key clinical trials1,3,4
In a 6-week randomized, double-blind, placebo-controlled, parallel study in adults under 65 (N=308):
LUNESTA Helped Patients Fall Asleep Faster vs.
Placebo as objectively measured by latency to
persistent sleep (LPS)
Primary Endpoint: LUNESTA 2 mg (n=104) and 3 mg (n=105) significantly decreased LPS vs. placebo (n=99) at 4 weeks (12.9 min and 11.5 min vs. 20.5 min, p<0.01)1,3
LUNESTA Improved Measures of Sleep Maintenance
vs. Placebo as objectively measured by wake after
sleep onset (WASO)
Secondary Endpoint: LUNESTA 3 mg (n=105) significantly reduced WASO vs. placebo (n=99) (33.8min vs. 44.1min, p<0.01)1,3
Reduction in WASO was not statistically significant relative to placebo for ESZ 2 mg.
In a 6-month, randomized, double-blind, placebo-controlled study in adults under 65 (N=828):
LUNESTA Helped Patients Fall Asleep Faster vs.
Placebo as subjectively measured by patient
-reported sleep latency
Primary Endpoint: LUNESTA 3 mg (n=548) was superior to placebo (n=280) in decreasing patient-reported sleep latency (SL) for the month 4-6 average (27.3 min vs. 45.0 min, p<0.0001)1,4‡
LUNESTA Reduced Wake After Sleep Onset vs. Placebo
Secondary Endpoint: LUNESTA 3 mg (n=548) was superior to placebo (n=280) in reducing patient-reported wake after sleep onset (WASO) for the month 4-6 average (14.7 min vs. 26.1 min, p<0.0001) 1,4‡
LUNESTA Increased Total Sleep Time vs. Placebo
Secondary Endpoint: LUNESTA 3 mg (n=548) was superior to placebo (n=280) at increasing patient-reported total sleep time (TST) for the month 4-6 average (396.5min vs. 345.0min, p<0.0001)1,4‡
‡SL values >540 min., WASO values >540 min. and TST values of >840 min. were excluded from this analysis.
LUNESTA Was Generally Well-Tolerated in Adults
In placebo-controlled, parallel-group clinical trials in the elderly, a 6-week parallel-group study in adults, and a long-term 6-month study in adult insomnia patients, the most frequently observed adverse events during these trials include unpleasant taste (dysgeusia), dizziness, somnolence, and dry mouth.
Tolerance Observations in Clinical Trials with
- In clinical studies with LUNESTA, no development of tolerance to any median parameter of sleep measurements was observed during treatment periods of up to 12 months1
- Development of tolerance in some patients cannot be excluded
Dosing and Administration
LUNESTA: Once daily, at bedtime1
Recommended Starting Dose: 1 mg
Tablets shown not actual size.
- Dose can be increased to 2 mg or 3 mg if clinically indicated
- Use the lowest effective dose of LUNESTA possible for the patient
- Total dose should not exceed 3 mg
- The length of treatment should be for the minimum duration necessary for the patient
- 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
Please refer to the Product Monograph for complete dosing and administration information.