> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Eisai Insomnia Drug Approved by FDA
- URL: https://www.fdaweb.com/eisai-insomnia-drug-approved-by-fda/
- Published: 2020-01-03T12:00:00.000Z
- Updated: 2026-09-14T15:57:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145760

FDA has approved an Eisai NDA for Dayvigo (lemborexant) 5 mg and 10 mg for treating adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The approval was based on data from two pivotal Phase 3 studies, which evaluated the drug versus placebo for up to one month and then for six months. The agency recommended that Dayvigo be classified as a controlled substance. The most common adverse reaction in both studies was somnolence and nightmares.