Silexan does not cause withdrawal symptoms even when abruptly discontinued.
OBJECTIVE
Subsequent to a randomised, double-blind, double dummy clinical trial assessing the efficacy of silexan compared to placebo and paroxetine in patients suffering from generalised anxiety disorder (GAD), a 1week follow-up phase was added in order to assess possible withdrawal symptoms of silexan after abrupt discontinuation.


METHODS
Participants received silexan 80 mg/d, silexan 160 mg/d, paroxetine 20 mg/d, or placebo at a ratio of 1:1:1:1. Study medication was discontinued after the 10 week active treatment phase of the original trial. Whereas paroxetine was tapered as indicated, silexan administration was discontinued abruptly. Assessment of possible withdrawal effects was done using the Physician Withdrawal Checklist questionnaire (PWC-20).


RESULTS
During the 1 week down-titration phase, mean total PWC-20 scores had reduced by 0.19 in placebo, 0.23 in silexan 80, 0.65 in silexan 160, and 0.51 in paroxetine. The median change in all four groups was 0.00. In none of the treatment groups withdrawal effects occurred after discontinuation.


CONCLUSIONS
Values assessed for the silexan groups indicate the absence of a dependency potential of this preparation.
a Fliedner Klinik Berlin , Berlin , Germany.
M
M
Gastpar
b Department of Pharmacology , Biocenter Goethe-University , Frankfurt , Germany.
W E
WE
Müller
c Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine, Schloss Werneck , Werneck , Germany.
H P
HP
Volz
d Clinic for Psychiatry and Psychotherapy , Ludwig Maximilians University , Munich , Germany.
H J
HJ
Möller
e Dr. Willmar Schwabe GmbH & Co. KG , Karlsruhe , Germany.
S
S
Schläfke
e Dr. Willmar Schwabe GmbH & Co. KG , Karlsruhe , Germany.
A
A
Dienel
f Department of Psychiatry and Psychotherapy , Medical University of Vienna , Vienna , Austria.
S
S
Kasper
D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects; D001008:Anxiety Disorders / Q000188:drug therapy; D004311:Double-Blind Method; D006801:Humans; D027523:Lavandula; D009822:Oils, Volatile / Q000008:administration & dosage* / Q000009:adverse effects*; D017374:Paroxetine / Q000009:adverse effects; D010938:Plant Oils / Q000008:administration & dosage* / Q000009:adverse effects*; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis*
D014151:Anti-Anxiety Agents; D009822:Oils, Volatile; D010938:Plant Oils; D017374:Paroxetine; C045718:lavender oil
Discontinuation effects; GAD; PWC-20; lavender oil; silexan