Lemborexant for Insomnia: Over 50% of Older Adults Respond Well After 1 Month

After 1 month of lemborexant treatment, nearly 30% and over 50% of older adults with insomnia disorder and objective short sleep achieved remission and responded to treatment, respectively, according to study results presented at the 2024 American Academy of Neurology (AAN) annual meeting, held from April 13 to 18, 2024, in Denver, Colorado.

Researchers conducted a phase 3 study (E2006-G000-304; Study 304; ClinicalTrials.gov Identifier: NCT02783729) and found that lemborexant improved polysomnographic endpoints and sleep diary-based outcomes over the course of 1 month in patients with insomnia disorder. Researchers examined the rates of response and remission in patients with insomnia disorder and objective short sleep since those who receive less than 6 hours of total sleep time per night may respond less well to therapeutic approaches such as cognitive behavioral therapy (CBT) for insomnia. Patients were randomly assigned to receive lemborexant 5 mg or 10 mg, placebo, or zolpidem extended release for 1 month. During a single-blind placebo run-in, paired baseline polysomnographic endpoints were obtained, followed by paired polysomnographic endpoints on nights 1/2 and 29/30. Response was defined as a 7 point and more decrease in Insomnia Severity Index total score from baseline to end of treatment. Remission was defined as an Insomnia Severity Index total score of less than 8 points.

Of the 743 patients in the placebo and lemborexant groups, 525 (70.7%) were in the insomnia disorder and objective short sleep subgroup. Of the 178 patients who received lemborexant 5 mg, 100 (56.2%) responded to treatment and 50 (28.1%) achieved remission. Of the 180 patients who received lemborexant 10 mg, 97 (53.9%) responded to treatment and 50 (27.8%) achieved remission. Of the 138 patients who received placebo, 58 (42.0%) responded to treatment and 20 (14.5%) achieved remission. Compared with the response and remission rates of placebo, those of lemborexant 5 mg and 10 mg were significantly greater (P <.05). Lemborexant was tolerated and treatment-emergent adverse events were mostly mild or moderate in severity.

“LEM [lemborexant] is a potential therapy for patients with I-SSD [insomnia disorder and objective short sleep], including those with limited response to CBT-I [CBT for insomnia],” the researchers concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.