A once-a-day oral
milnacipran pulsatile release composition has been developed that releases the
drug in spaced apart “pulses”. The dosage forms are comprised of first, second and optional third dosage units, with each dosage unit having a different
drug release profile. This
dosage form provides
in vivo drug plasma levels characterized by Cmax below 3000 ng / ml, preferably below 2000 ng / ml, and most preferably below 1000 ng / ml. The composition provides pulsatile release of
milnacipran to produce a
therapeutic effect over approximately 24 hours, when administered to a patient in need, resulting in diminished incidence or decreased intensity of common
milnacipran side effects such as sleep disturbance,
nausea,
vomiting, headache, tremulousness,
anxiety,
panic attacks,
palpitations,
urinary retention, orthostatic hypotension,
diaphoresis,
chest pain,
rash,
weight gain,
back pain,
constipation, vertigo, increased sweating, agitation, hot flushes, tremors, fatigue,
somnolence, dyspepsia, dysoria, nervousness,
dry mouth,
abdominal pain,
irritability, and
insomnia.