Dayvigo Cost vs. Alternatives: Comparing Lemborexant to Other Insomnia Treatments

What the label establishes

Dayvigo is oral lemborexant, approved by FDA on December 20, 2019 under NDA 212028 for adults with insomnia characterized by difficulty with sleep onset, sleep maintenance, or both [2][3]. The label has no boxed warning, and narcolepsy is its only contraindication [3]. The label describes the mechanism as blocking orexin A and orexin B at receptors OX1R and OX2R, which is thought to suppress wake drive; it is not a benzodiazepine or a Z-drug [3]. Dayvigo is a Schedule IV controlled substance [3].

The trial that compared Dayvigo with another sleeping pill

SUNRISE 1 was a one-month randomized trial of 1,006 adults aged 55 and older with insomnia disorder. Participants received placebo, zolpidem extended-release 6.25 mg, or lemborexant 5 mg or 10 mg [1]. Against placebo, the ratio for latency to persistent sleep was 0.77 at 5 mg and 0.72 at 10 mg, both P<.001; sleep efficiency rose 7.1% and 8.0% and wake after sleep onset fell 24.0 and 25.4 minutes [1]. Wake after sleep onset in the second half of the night was 6.7 minutes lower at 5 mg and 8.0 minutes lower at 10 mg than with zolpidem extended-release 6.25 mg [1]. The trial measured polysomnographic sleep, not cost [1]. Longer-term data come from SUNRISE 2, which randomized 949 adults aged 18 and older to placebo, lemborexant 5 mg or 10 mg for a 6-month placebo-controlled period inside a 12-month trial; patient-reported sleep onset latency, wake after sleep onset and sleep efficiency improved significantly versus placebo at month 6 [5].

What the label says about dose and interactions

According to the Dayvigo label, the recommended dose is 5 mg no more than once nightly, immediately before bed, with at least 7 hours remaining before planned awakening. The label permits an increase to a maximum of 10 mg based on clinical response and tolerability [3]. The label says to avoid strong or moderate CYP3A inhibitors and inducers. With weak CYP3A inhibitors, the label sets a maximum of 5 mg; it lists itraconazole and clarithromycin as strong inhibitors, fluconazole and verapamil as moderate inhibitors, chlorzoxazone and ranitidine as weak inhibitors, and rifampin, carbamazepine and St. John's wort among the inducers [3]. The label also advises against alcohol with Dayvigo and states that use with other insomnia drugs is not recommended [3].

Side effects the label reports

The most common adverse reaction was somnolence, reported in 10% of patients on 10 mg, 7% on 5 mg and 1% on placebo in the first 30 days of the two trials; headache was 4.5%, 5.9% and 3.4% [3]. The label states that Dayvigo can impair daytime wakefulness even when used as prescribed and that these effects may persist for up to several days after stopping; driving ability was impaired in some subjects taking 10 mg [3].