Lunesta Hair and Skin Changes: What Eszopiclone Actually Does (and Doesn't Do)

At a glance

  • Drug / eszopiclone (Lunesta), an oral Schedule IV hypnotic for insomnia [1]
  • Rash, 6-week adult trial / 1% placebo, 3% at 2 mg, 4% at 3 mg [1]
  • Dose-response / the label lists rash among reactions that suggest one [1]
  • Pruritus, elderly 2-week trials / 4% at 1 mg vs 1% placebo [1]
  • Hypersensitivity / angioedema and anaphylaxis; no rechallenge after angioedema [1]
  • 6-month randomized trial / 788 adults, 3 mg vs placebo [2]
  • 12-month data / open-label extension; no placebo comparison [3]
  • Boxed warning / complex sleep behaviors, not a skin reaction [1]

Hair loss: other explanations

Hair loss has well-described causes unrelated to this drug. In one review, genetic hair loss is the major problem in men and up to 50% are affected by age 50 [4]. In women before the age of 50 the review names nutritional causes as the major one, with 30% affected; increased and persistent shedding (chronic telogen effluvium) and reduced hair volume are the principal changes, and depleted iron stores compromised by low intake of the amino acid l-lysine appear to be the main driver [4]. The authors report that correcting these imbalances stops the excessive hair loss, though it can take many months [4].

What the trials do report is a narrow adverse-event profile. In the 6-month randomized trial, the most common adverse events were unpleasant taste and headache [2]. In the 12-month open-label extension, unpleasant taste was the only undesirable effect reported by more than 5% of patients [3].

What skin reactions does the label list?

The clearest skin finding is rash. In a 6-week placebo-controlled trial in nonelderly adults, rash occurred in 1% of patients on placebo (n=99), 3% on eszopiclone 2 mg (n=104) and 4% on 3 mg (n=105) [1]. The label lists rash among the reactions that suggest a dose-response relationship [1].

In the 2-week trials in adults aged 65 to 86, pruritus occurred in 4% of patients on 1 mg (n=72) and 1% on 2 mg (n=215), compared with 1% on placebo (n=208) [1]. Rash was not higher than placebo in those elderly trials [1].

The label also warns about angioedema and anaphylaxis. Rare cases of angioedema involving the tongue, glottis or larynx have been reported after the first or subsequent doses of sedative-hypnotics, including Lunesta; airway obstruction may occur and be fatal [1]. The label says patients who develop angioedema after Lunesta should not be rechallenged, and it lists known hypersensitivity to eszopiclone as a contraindication [1].

What did the 6-month and 12-month trials show?

Krystal et al. (Sleep, 2003) randomized 788 adults aged 21 to 69 with primary insomnia to eszopiclone 3 mg (n=593) or placebo (n=195) nightly for 6 months [2]. Sleep latency, wake time after sleep onset, total sleep time and sleep quality improved versus placebo throughout the study, with no evidence of tolerance; the most common adverse events were unpleasant taste and headache [2]. Outcomes were patient-reported through an interactive voice-response system [2].

Roth et al. (Sleep Medicine, 2005) described the 6-month open-label extension. Patients originally assigned to placebo switched to open-label eszopiclone (n=111); 360 patients sustained their double-blind gains, and unpleasant taste was the only undesirable effect reported by more than 5% [3]. The extension had no placebo comparison [3].

Does poor sleep itself affect skin?

One study of 60 healthy women compared poor sleepers (PSQI greater than 5, sleep duration 5 hours or less) with good sleepers (PSQI 5 or less, 7 to 9 hours) [5]. Good sleepers had lower intrinsic skin-ageing scores; poor sleepers had higher baseline transepidermal water loss, and good sleepers had 30% greater barrier recovery 72 hours after tape stripping [5]. Good sleepers also had better recovery from ultraviolet-induced erythema at 24 hours and reported better satisfaction with appearance [5]. The study did not test eszopiclone and did not measure hair loss [5].

Frequently asked questions

What skin reactions does Lunesta list?
Rash is the main one: 1% on placebo, 3% on 2 mg and 4% on 3 mg in a 6-week adult trial [1]. The label also warns of rare angioedema and anaphylaxis, which can involve the tongue, glottis or larynx and can be fatal [1].
What are known causes of hair shedding?
One review describes pattern hair loss as the major problem in men, affecting up to 50% by age 50; in women before 50 it names depleted iron stores and low l-lysine intake as the main cause, with chronic telogen effluvium and reduced hair volume the typical changes [4].
How serious is angioedema with Lunesta?
The label describes rare angioedema of the tongue, glottis or larynx after the first or later doses, with possible fatal airway obstruction, and says patients who develop it should not be rechallenged [1].
Does poor sleep affect skin?
In one study of 60 women, poor sleepers had higher intrinsic skin-ageing scores, and good sleepers had 30% greater barrier recovery than poor sleepers [5]. The study did not test eszopiclone or measure hair loss [5].
What is the boxed warning for Lunesta?
Complex sleep behaviors such as sleep-walking and sleep-driving, which can cause serious injury or death; it is not a skin warning [1]. The label says to discontinue Lunesta immediately if a complex sleep behavior occurs [1].

References

  1. U.S. National Library of Medicine, DailyMed. Lunesta (eszopiclone) tablets prescribing information. Lunesta (eszopiclone) tablets label
  2. Krystal AD, Walsh JK, Laska E, Caron J, Amato DA, Wessel TC, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep. 2003;26(7):793-9. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia
  3. Roth T, Walsh JK, Krystal A, Wessel T, Roehrs TA. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Med. 2005;6(6):487-95. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia
  4. Rushton DH, Norris MJ, Dover R, Busuttil N. Causes of hair loss and the developments in hair rejuvenation. Int J Cosmet Sci. 2002;24(1):17-23. Causes of hair loss and the developments in hair rejuvenation
  5. Oyetakin-White P, Suggs A, Koo B, Matsui MS, Yarosh D, Cooper KD, et al. Does poor sleep quality affect skin ageing?. Clin Exp Dermatol. 2015;40(1):17-22. Does poor sleep quality affect skin ageing?
Evidence overview for Lunesta Hair and Skin Changes: What Eszopiclone Actually Does (and Doesn't Do)