Lemborexant Increases Total Sleep Time in Patients With Insomnia, Mild OSA

Lemborexant is associated with significantly increased total sleep time, comprised primarily with rapid eye movement (REM) sleep, in patients with insomnia and mild obstructive sleep apnea (OSA), according to study results presented at the 2023 Annual Meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held from June 3 to 7 in Indianapolis, Indiana.

In a phase 3, randomized, double-blind, placebo-controlled and active-comparator trial (SUNRISE; ClinicalTrials.gov Identifier: NCT02783729), researchers assessed whether lemborexant, a dual-orexin-receptor antagonist approved to treat adults with insomnia, is effective in patients with insomnia and concomitant mild OSA (defined as apnea hypopnea index ≥5 to <15).

A total of 409 adults aged 55 years and older diagnosed with insomnia and mild OSA were recruited and randomly assigned to receive lemborexant 5 mg (n=114), lemborexant 10 mg (n=105), zolpidem tartrate extended-release 6.25 mg (n=112), or placebo (n=78).

The researchers compared the least-squares-mean duration of each sleep stage (in minutes) across nights 1/2 vs nights 29/30.

Total Sleep Time

Study results indicate that compared with patients who received zolpidem tartrate extended-release 6.25 mg or placebo (P <.0001), those who received lemborexant 5 or 10 mg experienced a significantly higher mean change from baseline in both post-randomization assessments (nights 1/2 and nights 29/30).

REM Sleep

Compared with patients who received zolpidem tartrate extended-release 6.25 mg or placebo (P <.0001), both dosages of lemborexant were associated with significant mean [SD] change from baseline in both post-randomization assessments (nights 1/2 and nights 29/30).

Mean Change from Baseline to Post-Randomization Assessments: REM Sleep

NonREM Sleep

Compared with patients who received placebo (P <.0001), both dosages of lemborexant were associated significant mean [SD] change from baseline in both post-randomization assessments (nights 1/2 and nights 29/30). Neither dosage of lemborexant was superior to zolpidem tartrate extended-release 6.25 mg at nights 1/2, and only lemborexant 5 mg significantly improved nonREM sleep at night 29/30 (P <.05).

Mean Change From Baseline to Post-Randomization Assessments: REM Sleep

The researchers concluded that “LEM [lemborexant] significantly increased total sleep time in subjects with insomnia and mild OSA. The additional sleep was comprised importantly with REM sleep …” Overall, lemborexant was well-tolerated and no severe treatment-emergent adverse events were reported.