The unmet need for new drugs against insomnia.

Benzodiazepines or Z-drugs (such as zolpidem, zopiclone, and eszopiclone) have dominated the market for pharmacological treatments for insomnia for the past 30 years, but due to their unfavorable side effect profile, additional treatment options are needed.

There are currently four Phase 3 products in development for the treatment of insomnia. However, they do not have novel mechanisms of action that differentiate them from marketed products. The approval of dual orexin receptor antagonists (Suvorexant, lemborexant and daridorexant) for the treatment of insomnia, which selectively inhibit arousal and promote sleep, offer a superior safety profile compared to Z-drugs. Unlike Z-drugs, discontinuation of DORA (dual orexin receptor antagonists) treatment is not associated with rebound insomnia.

There are a limited number of late-stage agents for insomnia, with only four products in Phase 3 development: Vanda Pharmaceuticals' Hetlioz (tasimelteon), EUSOL Biotech's SM-1 (diphenhydramine + lorazepam + zolpidem), Taisho Pharmaceutical's vornorexant, and Johnson & Johnson's seltorexant.

Hetlioz (tasimelteon) is an FDA-approved melatonin agonist for two rare sleep disorders: non-24-hour sleep/wake disorder and Smith-Magenis syndrome. But Vanda Pharmaceuticals is looking to expand its labels and plans to file a supplemental new drug application for the treatment of insomnia in 2024. This would allow the drug to compete with marketed melatonin receptor agonists, including Takeda’s Rozerem (ramelteon) and its generic versions.

Taisho’s vornorexant could be the next DORA to enter the market, competing with Merck’s Belsomra (suvorexant), Eisai’s Dayvigo (lemborexant), and Idorsia’s Quviviq (daridorexant). Unlike DORAs, which target both the orexin type 1 and type 2 receptors, Johnson and Johnson’s seltorexant selectively antagonizes the orexin type 2 receptor and is being investigated as an add-on therapy to antidepressants for patients with major depressive disorder and insomnia symptoms.

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Source: https://sleepreviewmag.com/sleep-disorders/insomnia/unmet-need-new-insomnia-drugs/