Active Ingredient: Daridorexant
Daridorexant is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
25 - 50 mg
From 25 To 50 mg once every day
The recommended dose for adults is 50 mg once per night, taken orally in the evening within 30 minutes before going to bed. Based on clinical judgement, some patients may be treated with 25 mg once per night.
The maximum daily dose is 50 mg.
The treatment duration should be as short as possible. The appropriateness of continued treatment should be assessed within 3 months and periodically thereafter. Clinical data are available for up to 12 months of continuous treatment.
Treatment can be stopped without down-titration.
If a patient forgets to take daridorexant at bedtime, that dose should not be taken during the night.
In patients with mild hepatic impairment, no dose adjustment is required. In patients with moderate hepatic impairment, the recommended dose is one tablet of 25 mg once per night.
Daridorexant can be taken with or without food. However, taking daridorexant soon after a large meal may reduce the effect on sleep onset.
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