Dayvigo Hair and Skin Changes: What the Evidence Actually Shows

Does Dayvigo cause hair loss?

Lemborexant's listed trial reactions do not include hair loss. The Dayvigo label's Table 1 covers reactions reported in 2% or more of patients and more often than on placebo during the first 30 days of the two controlled trials. The label separately lists less common reactions from those trials: sleep paralysis, hypnagogic hallucinations and complex sleep behaviors. Alopecia is in neither list [1]. The label also says that list leaves out reactions for which a drug cause was remote, that were too general to be informative, or that were not considered clinically significant [1].

The trials behind that label were large. SUNRISE 1 randomized 1,006 adults aged 55 and older to placebo, zolpidem extended release 6.25 mg, lemborexant 5 mg or lemborexant 10 mg for 1 month [3]. SUNRISE 2 randomized 949 adults aged 18 and older to placebo, 5 mg or 10 mg for a 6-month placebo-controlled period within a 12-month trial [4]. Treatment-emergent adverse events were monitored throughout [4]. In the 12-month continuous-treatment report, the most common events were nasopharyngitis, somnolence and headache [5].

Does lemborexant cause rash or skin changes?

The label's Warnings and Precautions section covers daytime impairment and CNS depression, sleep paralysis and hypnagogic or hypnopompic hallucinations, cataplexy-like symptoms, complex sleep behaviors, compromised respiratory function, and worsening depression or suicidal ideation [1]. None of those items concerns skin or hair. The only contraindication is narcolepsy [1].

Rash and dermatitis are likewise not named in the trial adverse-reaction table or in the list of less common trial reactions [1].

What the label does list

Somnolence is the reaction reported in 5% or more of patients and at least twice the placebo rate: 10% on 10 mg, 7% on 5 mg and 1% on placebo during the first 30 days of the two trials, in a safety population of 1,418 patients [1]. In the pooled table of reactions reported in 2% or more of patients, somnolence or fatigue was 9.6% on 10 mg, 6.9% on 5 mg and 1.3% on placebo; headache 4.5%, 5.9% and 3.4%; nightmare or abnormal dreams 2.2%, 0.9% and 0.9% [1].

Sleep paralysis was reported in 1.6% of patients on 10 mg and 1.3% on 5 mg, versus none on placebo, and hypnagogic hallucinations in 0.7% and 0.1%, versus none [1]. Two complex sleep behaviors occurred in the trials, both at 10 mg [1]. Discontinuation for adverse reactions in the first 30 days was 2.6% on 10 mg, 1.4% on 5 mg and 1.5% on placebo, rising over 6 months to 8.3%, 4.1% and 3.8% [1].

Sleep and skin: what has been measured

Poor sleep and skin have been studied directly, though not with lemborexant. In a study of 60 healthy white women, poor sleepers (5 hours of sleep or less) had higher baseline transepidermal water loss than good sleepers (7 to 9 hours). At 72 hours after tape stripping, good sleepers had 30% greater barrier recovery. Good sleepers also recovered better from UV-induced erythema at 24 hours and had lower intrinsic skin ageing scores [2]. That study compared sleepers with each other and did not test any drug. A separate review describes several ways sleep disorders and skin conditions interact, including a possible effect of insomnia and sleep deprivation on dermatologic disorders [6].

Reports filed after approval: what they can and cannot show

FDA's adverse event dashboard states the limits of these reports: they are often duplicate or incomplete, submitting a report does not establish that the drug caused the event, and the data cannot be used to estimate how often an event occurs [7]. A report of hair shedding or a rash during lemborexant treatment would therefore show neither a rate nor a cause.