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Does Avodart (Dutasteride) Affect Sleep? What the Label Says

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At a glance

  • Drug / dutasteride (Avodart) 0.5 mg once daily, swallowed whole [1]
  • Approved use / symptomatic BPH with an enlarged prostate; hair loss is off-label [1]
  • Label listing for insomnia / not among the reactions reported in 1% or more of men and more often than placebo [1]
  • Half-life / about 5 weeks; about 90% of steady state by 3 months [1]

What does the Avodart label say about sleep?

The label's pooled placebo-controlled BPH trials randomized 4,325 men, 2,167 to dutasteride 0.5 mg daily and 2,158 to placebo; the men's mean age was 66. The label summarizes these trials through urinary symptom scores and adverse reactions [1]. Its table of reactions reported in at least 1% of treated men and more often than placebo lists impotence, decreased libido, ejaculation disorders and breast disorders. Insomnia is not in that table. A reaction below the 1% threshold, or one no more common than on placebo, would not appear there [1].

The label notes that the sexual reactions may persist after treatment is discontinued and that dutasteride's role in that persistence is unknown [1].

What is known about mood?

Depressed mood appears among the Avodart label's postmarketing reports. The label does not list suicidal ideation [1].

A Swedish register study followed 2.2 million men aged 50 to 90. Among the 8,774 men who started dutasteride, the hazard ratio for depression was 1.68 (95% CI 1.43 to 1.96), and it stayed constant over time. Suicide was not associated with dutasteride (HR 0.98, 95% CI 0.62 to 1.54). The study was observational and mostly involved older men treated for BPH [2].

Frequently asked questions

Does dutasteride cause insomnia?
Insomnia is not among the reactions the Avodart label reports in at least 1% of treated men and more often than placebo; that table lists impotence, decreased libido, ejaculation disorders and breast disorders [1].
Does dutasteride change REM or deep sleep?
The label describes the BPH trials in terms of urinary symptom scores and adverse reactions, and it does not describe any effect on REM or deep sleep [1].
Does dutasteride affect mood?
Depressed mood appears among the Avodart label's postmarketing reports [1]. In a Swedish register study, men who started dutasteride (8,774) had a depression hazard ratio of 1.68 (95% CI 1.43 to 1.96), while suicide was not associated (HR 0.98). The study was observational and mostly involved older men treated for BPH [2].

References

  1. U.S. National Library of Medicine, DailyMed. Avodart (dutasteride) soft gelatin capsules, Waylis Therapeutics prescribing information. Avodart (dutasteride) soft gelatin capsules, Waylis Therapeutics label
  2. Garcia-Argibay M, Hiyoshi A, Fall K, Montgomery S. Association of 5α-Reductase Inhibitors With Dementia, Depression, and Suicide. JAMA Netw Open. 2022;5(12):e2248135. Association of 5α-Reductase Inhibitors With Dementia, Depression, and Suicide
Evidence overview for Does Avodart (Dutasteride) Affect Sleep? What the Label Says