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Sampling time, dosage schedule, and nortriptyline plasma levels

V E Ziegler, J W Knesevich, L T Wylie

    Archives of General Psychiatry
    |May 1, 1977
    PubMed
    Summary
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    Steady-state nortriptyline plasma levels remained stable and comparable between once-daily bedtime and three-times-daily dosing schedules. Most patients showed no clinically significant differences in nortriptyline levels between the two dosing regimens.

    Area of Science:

    • Pharmacology
    • Clinical Pharmacy
    • Pharmacokinetics

    Background:

    • Nortriptyline is a tricyclic antidepressant with a narrow therapeutic index.
    • Optimizing nortriptyline dosing regimens is crucial for maximizing efficacy and minimizing toxicity.
    • Understanding the impact of different dosing frequencies on plasma levels is essential for clinical practice.

    Purpose of the Study:

    • To compare steady-state plasma nortriptyline levels in patients receiving a single daily bedtime dose versus a three-times-daily divided dose.
    • To assess the clinical significance of observed differences in plasma nortriptyline concentrations between the two dosing schedules.

    Main Methods:

    • Eight patients receiving nortriptyline hydrochloride were studied.
    • Plasma nortriptyline levels were measured at multiple time points (9 AM, 12 PM, 3 PM, 6 PM) under two different dosing schedules: once daily at bedtime (10 PM) and three times daily (10 AM, 4 PM, 10 PM).

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  • Differences in plasma levels between the two schedules were analyzed for clinical significance.

    • Main Results:

    • Overall mean plasma nortriptyline levels were stable during sampling periods and comparable between the two dosing schedules.
    • As anticipated, plasma levels decreased later in the day with the bedtime (hs) schedule and increased with the three-times-daily (tid) schedule.
    • In seven out of eight patients, the differences in plasma levels between the two schedules were less than 30 ng/ml, considered not clinically significant.
    • One patient exhibited a clinically significant higher plasma nortriptyline level on the tid schedule.

    Conclusions:

    • Dosing frequency of nortriptyline (once daily vs. three times daily) had minimal impact on overall steady-state plasma levels in most patients.
    • Standardization of blood sampling times is critical for accurate interpretation of plasma drug levels and therapeutic response in clinical studies.
    • Individual patient responses may vary, necessitating careful monitoring even when general trends suggest comparability.