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Concerning adverse outcomes, it is significant to note that 99.68% of patients experienced at least one serious adverse outcome, with 5.06% resulting in death (DE) and 15.27% classified as life-threatening (LT)

When a sleep disturbance is determined to be directly and temporally linked to another mental, physical, or sleep problem, comorbid insomnia is diagnosed (Morin & Benca, 2011).The DSM-5 and ICSD-3 criteria require a subjective report of a sleep complaint (difficulty falling asleep, staying asleep, or waking up early) occurring at least three times a week for three months, along with at least one related daytime impairment (fatigue, attention impairment, mood disturbance, or impaired performance), in order to diagnose chronic insomnia (Saddichha, 2010)

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Most patients start with a low-to-moderate dose given one to three times per week, usually tied to training days or the day before heavy sessions

Pharmacovigilance in Russia: current state of affairs, challenges, and prospects