Regulatory Decision Summary for LUNESTA

Lunesta is a sedative-hypnotic drug of the same class as Imovane (zopiclone) and Sublinox (zolpidem), the latter two drugs already marketed in Canada. Lunesta is effective for short-term symptomatic relief of insomnia; it has a positive effect on sleep induction and sleep maintenance, including early morning awakenings.

Adverse events (AEs) of special interest for this class include next-day residual effects, dizziness, abuse, tolerance and withdrawal upon discontinuation.

Next-day residual effects are a major concern with sedative-hypnotics. These effects were studied in a placebo-controlled trial that revealed a maximum effect at 7.5 hours post-dose but still present in some patients after 11.5 hours.

Abuse and dependence are also safety concerns. An abuse dependence liability study showed a potential for abuse that seemed smaller than with diazepam (from the benzodiazepine class of drugs, known for their established abuse and dependence potential). The liking of both drugs increased as the dose increased while the dislike of the drug seemed more important with Lunesta than diazepam with increasing doses.

Rebound insomnia can be an issue with sedative-hypnotic drugs. An increase in sleep latency was observed for one to two nights following 6 months of daily administration. Sleep latency was back to baseline by Night 3 without intervention.

Recommendations to manage AEs and mitigate next-day residual effects, rebound insomnia, abuse and dependence have been included in the Product Monograph and are reflected in the Indication, Contraindications and Warnings and Precautions.

The sponsor submitted a Risk Management Plan that was reviewed by Health Canada and deemed acceptable.

Considering the efficacy and the safety assessment, the benefit-risk of Lunesta is considered positive.