This trial is active, not recruiting.

Condition insomnia
Treatment eszopiclone
Sponsor Eisai Co., Ltd.
Start date October 2012
End date November 2014
Trial size 3300 participants
Trial identifier NCT02452684, LUN01S


To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Participants with insomnia who will receive eszopiclone, per approved label.
eszopiclone EZOP; Lunesta
The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.

Primary Outcomes

Assessment of overall improvement
time frame: Up to 4 weeks

Secondary Outcomes

Number of participants with adverse events (AEs)
time frame: Up to 4 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. Insomnia participants who did not take eszopiclone before assessment 2. Participants who receive assessment by using sleep questionaries

Additional Information

Official title Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients (Study LUN01S)
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Eisai Inc..