Modified-release hydrocortisone (Efmody) improves sleep, circadian alignment, and quality of life in patients with addison

Roxana Maria Tudor; John Hayden; Tommy Kyaw Tun; Colin Davenport; Seamus Sreenan; Mark Sherlock; Shabahat Shah; Amar Agha; Andrew Coogan; John McDermott

doi:10.1530/endoabs.115.OC2

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Endocrine Abstracts (2026) 115 OC2 | DOI: 10.1530/endoabs.115.OC2

IES2025 Oral Communications Oral Communications (14 abstracts)

Modified-release hydrocortisone (Efmody) improves sleep, circadian alignment, and quality of life in patients with addison’s disease: a phase IIb crossover trial

Roxana Maria Tudor ^1,2 , John Hayden ² , Tommy Kyaw Tun ¹ , Colin Davenport , Seamus Sreenan ^1,2 , Mark Sherlock M ^2,4 , Shabahat Shah ⁵ , Amar Agha ^2,4 , Andrew Coogan ³ & John McDermott ^1,2

Author affiliations

¹Connolly Hospital Blanchardstown; ²Royal College of Surgeons Ireland; ³National University of Ireland Maynooth; ⁴Beaumont Hospital Dublin; ⁵Our Lady’s Hospital Navan

Background: Conventional treatment for Addison’s disease (AD) with immediate-release hydrocortisone (IR-HC) does not replicate the natural circadian cortisol rhythm, potentially impairing sleep, circadian alignment and quality of life (QoL).

Aim: To evaluate the impact of switching from IR-HC to modified-release hydrocortisone (Efmody) on sleep, circadian hormonal patterns, and QoL in adults with AD.

Methods: In this phase IIb, open-label, within-subject crossover trial, adults with AD transitioned from their standard IR-HC regimen to an equivalent dose of Efmody for 12 weeks. Participants completed sleep questionnaires (Pittsburgh Sleep Quality Index [PSQI], Sleep Condition Indicator [SCI]), wore actigraphy devices for 14 days, and provided salivary cortisol and melatonin profiles before and during intervention. QoL was assessed using AddiQoL and SF-36.

Results: Efmody improved sleep efficiency (+4%, P = 0.002), reduced sleep latency (–11 min, P = 0.01), and decreased sleep fragmentation (all parameters P < 0.01). Subjective sleep improved, with SCI scores increasing (+5.9, P = 0.0033) and PSQI scores decreasing (–2.2, P = 0.0067). The number of patients reporting “good sleep” rose from 5 to 12. During Efmody treatment, cortisol exposure (AUC) was reduced (P = 0.012), with a morning peak approximating physiological rhythm; melatonin profiles retained evening peaks. Dim-light melatonin onset occurred 20 minutes later (P = 0.02) but remained aligned with sleep, indicating improved circadian–sleep synchrony. QoL improved, with SF-36 vitality (+20.0, P = 0.0002) and general health (+8.0, P = 0.0175) increasing, and AddiQoL total score rising (+7.4, P = 0.0003), with gains across all domains.

Conclusion: Switching to Efmody improved sleep quality, promoted more physiological circadian alignment, and enhanced QoL in AD.