UK Medicines Information
FDA adds Boxed Warning for risk of rare but serious injuries caused by complex sleep behaviour (CSB) with eszopiclone, zaleplon, and zolpidem
Information type:
Safety alerts
Source:
US Food and Drug Administration
Specialities:
Mental health and illness | Neurological disorders
Summary
66 cases, some fatal, including sleepwalking, sleep driving, and engaging in other activities while not fully awake have been reported over 26 years, thus use is contraindicated in patients who have previously experienced an episode of CSB with eszopiclone, zaleplon, and zolpidem
UKMi comment
Neither eszopiclone or zaleplon are licensed for use within the UK.
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