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A double-blind, randomized, placebo-controlled plus open trial of adjunctive suvorexant for treatment-resistant insomnia in patients with bipolar disorder.
Cafaro, Rita; Macellaro, Monica; Suppes, Trisha; Dell'Osso, Bernardo; Ketter, Terence; Ostacher, Michael; Miller, Shefali; Chang, Lauren; Lyu, Jihun; Wang, Po W.
Afiliación
  • Cafaro R; Departments of Biomedical and Clinical Sciences "Luigi Sacco" and Psychiatry, University of Milan, Milan, Italy.
  • Macellaro M; Departments of Biomedical and Clinical Sciences "Luigi Sacco" and Psychiatry, University of Milan, Milan, Italy.
  • Suppes T; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
  • Dell'Osso B; US Department of Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
  • Ketter T; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
  • Ostacher M; Departments of Biomedical and Clinical Sciences "Luigi Sacco" and Psychiatry, University of Milan, Milan, Italy.
  • Miller S; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
  • Chang L; Department of Health Sciences, "Aldo Ravelli" Center for Neurotechnology and Brain Therapeutic, University of Milan, Milan, Italy.
  • Lyu J; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
  • Wang PW; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
CNS Spectr ; : 1-9, 2024 May 24.
Article en En | MEDLINE | ID: mdl-38782461
ABSTRACT

BACKGROUND:

Sleep pattern alteration is a core feature of bipolar disorder (BD), often challenging to treat and affecting clinical outcomes. Suvorexant, a hypnotic agent that decreases wakefulness, has shown promising results in treating primary insomnia. To date, data on its use in BD are lacking. This study evaluated the efficacy and tolerability of adjunctive suvorexant for treatment-resistant insomnia in BD patients.

METHODS:

Thirty-six BD outpatients (19 BDI, 69.4% female, 48.9 [±15.2] years) were randomized for 1 week to double-blind suvorexant (10-20 mg/day) versus placebo. Then, all subjects who completed the randomized phase were offered open suvorexant for 3 months. Subjective total sleep time (sTST) and objective total sleep time (oTST) were assessed.

RESULTS:

During the randomized control trial (RCT) phase, an overall increase in the oTST emerged, which was statistically significant for the Cole-Kripke algorithm (p = 0.035). The comparison between the suvorexant and placebo groups was limited by significant differences between measurements at baseline. During the open phase, no significant improvement was detected relative to either sTST and oTST. No adverse events nor major intolerances were reported.

DISCUSSION:

Efficacy results are inconsistent. During the RCT phase, only a small increase in the objective oTST emerged, while during the open phase, no significant improvement was detected. While this is the first ever study of suvorexant in BD-related insomnia, the limitation of the small sample and the high rate of dropouts limits the generalizability of these findings. Larger studies are needed to assess suvorexant in treating BD-related insomnia.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: CNS Spectr Asunto de la revista: NEUROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: CNS Spectr Asunto de la revista: NEUROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Estados Unidos