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LUNESTA safety information

Similarly, reports of dependence have been very low (10 lunesta cases; 0 .
Proposals for the Mitigation of the Risk of Dependence The Applicant proposes that for the subset of patients having chronic insomnia for which long-term treatment with a hypnotic may be warranted, the risks of dependence associated with Lunivia can be communicated and mitigated lunesta para que sirve eszopiclone drug class eszopiclone vs melatonin eszopiclone from canada through the following points: The Applicant seeks to work with the CHMP to provide additional discussion of the risks of long-term use in Sections 4 . 4 (Special warnings and precautions for lunesta use) of the SPC . 2 (Posology and lunesta method of administration) and Section 4 .
The Applicant proposes to conduct enhanced post marketing surveillance, the form of which can be further discussed and agreed lunesta with CHMP .
The Applicant will also make available smaller pack sizes of 10, 15 or lunesta 20 tablet count in addition to the 30 counts pack size to account for both short term and longer term use .
lunesta years eszopiclone is generic for what lunesta urine drug screen lunesta and alcohol high The Applicant’s contention that a sub-set of patients suffering from insomnia may need long term pharmacological treatment is considered founded .
The clinical trial database gives relevant information for the lunesta use of Lunivia for up to 12 months .
This is however due to the fact the applicant has conducted long term studies, despite regulatory constraint, than to any intrinsic safety or efficacy advantage over equivalent agents Pharmacovigilance Detailed description of the Pharmacovigilance system The CHMP considered that the Pharmacovigilance system as described lunesta vs ambien price lunesta uses side effects coming off lunesta lunesta use in elderly what by the applicant fulfils the legislative requirements .
Risk lunesta Management Plan The MAA submitted a risk management plan .

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