Posted by Anyuser on August 2, 2002, at 10:09:38
In reply to Re: Serzone » Anyuser, posted by Stan on August 2, 2002, at 2:27:41
This is from J Clin Psychiatry 2002;63, notes omitted by Anyuser. It was funded by Bristol-Meyers.
Once-Daily Dosing
Early studies documenting the efficacy of nefazodone used a b.i.d. dosing schedule partly based on the short half-life of the drug (i.e., 4-8 hours). More recent data, however, show no significant differences with once- versus twice-daily nefazodone. Markovitz and Wagner conducted a study of 209 patients with major depression to compare once-daily dosing at bedtime with b.i.d. dosing of nefazodone. The titration schedules utilized, mean daily dose, and mean length of therapy are noted in Table. 2 [omitted by Anyuser]. According to CGI scores, 77% of bedtime-treated patients and 75% of b.i.d.-treated patients improved (defined as > 50% improvement in depressive symptoms); 51% and 43% of bedtime- and b.i.d.-treated patients, respectively, were complete responders. Dropout rates were 11.3% and 8.2%. for bedtime- and b.i.d.-treated patients, respectively. The investigators concluded that the efficacy and tolerability of nefazodone administered once daily at bedtime are comparable to those of b.i.d. administration.
To determine whether efficacy and tolerability would be maintained with the bedtime dosing, Preskorn and colleagues conducted a 12-week, open-label continuation study in 47 depressed patients who responded to 12 weeks of nefazodone b.i.d. therapy (300--600 mg/day). At the end of the l2-week acute phase, patients' morning doses of nefazodone were halved and evening doses were increased by 50%; after 1 week, the entire daily dose was administered in the evening. Of 41 evaluable patients, antidepressant response was maintained or improved in 39 patients (95%) according to CGI-Improvement and -Severity of Illness subscales. Most patients (89%) tolerated the switch to a bedtime dose regimen without difficulty. Five patients (11%) discontinued treatment during the initial 2-week period of dose transition, primarily for adverse events. Overall, patients maintained good clinical response, or experienced further improvement, with bedtime nefazodone continuation therapy, based on results of both clinician and patient ratings. The tolerability of once-daily nefazodone dosing was excellent, and no safety concerns were evident during this extended treatment. This open study suggests that once-daily dosing of nefazodone is a convenient and safe treatment option.
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