Drug intelligence / Profile preview

Sedistress

Development stage
Phase 4
Lead developer
Tilman
Modality
Small Molecules
Administration
Oral
01

Overview

Sedistress is an oral traditional herbal medicinal product containing a standardized dry extract of the aerial parts of Passiflora incarnata (passionflower), developed as a mild hypnotic and sedative for relief of mental stress and to facilitate sleep in adults and adolescents over 12 years.[1][5] Each 200 mg coated tablet typically contains dry extract of Passiflora incarnata L. (aerial parts) equivalent to about 700–1000 mg of passionflower, obtained with 60% ethanol; a 100 mg hard capsule strength with proportionally lower content is also marketed in some countries.[1][4][8] Pharmacologically, passionflower extracts are thought to exert anxiolytic and sedative effects via modulation of central neurotransmission (including GABAergic pathways), although a precise molecular target has not been fully defined, and clinical use is based on traditional experience rather than modern randomized trials.[1][2][5] Sedistress is indicated as a non‑prescription product to reduce mild to moderate symptoms of mental stress such as nervousness, restlessness, anxiety or irritability, and to help with sleep onset when these complaints are transient and not severe.[1][2][3][6] It is authorized and marketed in several European countries under various brand names, with dosing typically 1–2 tablets in the morning and evening for stress (up to a maximum of 8 tablets/day) or 1–2 tablets about 30 minutes before bedtime to aid sleep.[1][4][5] The product is not recommended in pregnancy, breastfeeding, or in children under 12, and concomitant use with other sedatives such as benzodiazepines is generally discouraged without medical supervision, due to additive drowsiness.[1][3][5]

Brand names
Sedistress
Other names
Sedistress 200Sedistress200Sedistress-200Sedistress PassifloraSedistress coated tabletsSedistress 200 mg coated tabletsSedistress200 mg coated tabletsSedistress-200 mg coated tabletsSedistress 100Sedistress100Sedistress-100
02

Targets

GABRR (GABA-A receptor subunit rho)

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