DISCUSSION
Quetiapine for Insomnia: A Clinical Dilemma of Off-Label Use
Author information
- V.Yu. Skryabin
- Moscow Research and Practical Center on Addictions
- S.I. Sokolova
- Moscow Research and Practical Center on Addictions
- V.P. Petrovskiy
- Moscow Research and Practical Center on Addictions
- P.S. Makartseva
- Moscow Research and Practical Center on Addictions
- A.V. Masyakin
- Moscow Research and Practical Center on Addictions
- Published
- September 30, 2025
- Pages
- 72-76
Abstract
Quetiapine, despite the lack of registered indications for the treatment of insomnia, is widely used in small doses in clinical practice as a sleep aid. Its popularity is due to its pronounced sedative effect and perception as a relatively safe drug. However, a critical analysis of the data shows that the effectiveness of quetiapine for insomnia is limited and is mainly observed in patients with comorbid anxiety and depressive symptoms. In individuals without psychiatric pathology, the drug demonstrates weak and inconsistent effectiveness. The safety profile raises serious concerns: even at low doses, quetiapine is associated with daytime sedation, metabolic disorders, worsening of breathing during sleep, and risks for elderly patients. The use of quetiapine in the treatment of insomnia is accompanied by significant variability in clinical approaches and is not supported by recommendations from leading expert communities. In the absence of a convincing evidence base and in the presence of alternative agents with a better safety profile, off-label prescribing of quetiapine for insomnia requires rigorous justification, individual risk assessment, and a review of its role within rational pharmacotherapy.
Keywords
- quetiapine
- insomnia
- off-label use
- efficacy
- safety
- adverse drug reactions
How to Cite
References
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