Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 5 mg, 10 mg) |
| Drug Class | Orexin receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Summary
- Lemborexant (Dayvigo) is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. It has been found effective in improving various sleep parameters, including sleep onset latency, wake after sleep onset, total sleep time, and sleep efficiency.
- The analysis was derived from 13 systematic reviews/meta-analyses documents that provided a comprehensive summary focusing on lemborexant's safety and effectiveness compared to other drugs used for treating insomnia.
- Compared to other treatments like suvorexant and zolpidem, lemborexant demonstrated superiority over placebo, particularly in subjective reduction of time taken to fall asleep (sTSO) and duration spent awake after initially falling asleep (sWASO).
- In doses of 5mg or 10mg, it was highly effective at improving the quality of sleep while also having good tolerability. This ranks it as one of the most effective treatments currently available for enhancing key metrics related to sleeping patterns.
- Studies assessing its impact on next-day driving performance showed minimal impairment when compared against drugs such as zopiclone, indicating a lower risk of residual effects that could impair activities requiring alertness during daytime hours following consumption before bedtime.
- While dual orexin receptor antagonists, including lemborexant, have been associated with higher risks of adverse events such as excessive daytime drowsiness or paralysis during the REM stage, the overall safety profile remains broadly similar across different types of medications used for treating insomnia conditions.
- No significant interactions were found between treatment effects across different age groups, implying its suitability for both general population adults and older individuals, given its safe yet efficacious profile based upon data obtained through these studies.
- When directly compared with suvorexant and zolpidem, lemborexant consistently showed equal or superior efficacy in reducing sTSO, increasing total sleep time (sTST), and decreasing sWASO. Its ability to improve sleep parameters effectively, along with a safety profile that includes fewer dropouts due to adverse events, positions it favorably among available treatments for insomnia.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Dayvigo (lemborexant) Prescribing Information. | 2023 | Eisai Inc., Nutley, NJ |