The prescribing information for Dayvigo® (lemborexant) has been updated to include clinical trial data related to the use of the insomnia medication in patients with severe obstructive sleep apnea (OSA) and moderate to severe chronic obstructive pulmonary disease (COPD).
Dayvigo is an orexin receptor antagonist indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients. To fulfill a postmarketing requirement, Eisai conducted short-term clinical trials to evaluate the respiratory depressant effect of lemborexant in patients with compromised respiratory function.
The effect of lemborexant on respiratory function in patients with OSA was evaluated in 2 randomized, placebo-controlled, 2-period crossover studies (ClinicalTrials.gov Identifier: NCT03471871, NCT04647383). In both trials, patients were assessed following 8 consecutive nights of treatment with lemborexant 10mg.
Among the 37 patients with mild OSA (apnea-hypopnea index <15 events/hour of sleep), the mean treatment difference (lemborexant-placebo) on day 8 for the apnea-hypopnea index was reported to be -0.06 (95% CI, -19.5, 1.83). Among the 33 patients with moderate to severe OSA (apnea-hypopnea index ≥15 events/hour of sleep), the mean treatment difference on day 8 for the apnea-hypopnea index was 0.80 (95% CI, -4.88-3.29).
Lemborexant 10mg dosed once daily was also evaluated in 30 patients with moderate to severe COPD (ClinicalTrials.gov Identifier: NCT04647383). The mean treatment difference on day 8 for the mean peripheral capillary oxygen saturation during sleep was 0.47 (95% CI, 0.07-0.87). The treatment was not studied in patients with FEV1 < 30% of predicted.
Due to the short duration of the studies, in addition to other limitations, clinically meaningful respiratory effects of lemborexant cannot be excluded and should be considered when prescribing to patients with compromised respiratory function.
Dayvigo is supplied as 5mg and 10mg tablets. The recommended dose should be taken immediately before going to bed, with at least 7 hours remaining before the planned time of awakening.