DESCRIPTION
Dalmane is available as capsules
containing 15 mg or 30 mg flurazepam. Each also 15-mg capsules contains
corn starch, lactose, magnesium stearate and talc. Dalmane's molecular
name is flurazepam hydrochloride. Flurazepam is chemically C21-H23-Cl-F-N3-O.2CL-H.
It is a pale yellow, crytalline compound, freely soluble in U.S.P. alcohol
and very soluble in water. It has a molecular weight of 460.826.
CLINICAL PHARMACOLOGY
Flurazepam is rapidly absorbed from the gastrointestinal tract and is rapidly metabolized. It is excreted primarily in the urine. Following a single oral dose, peak flurazepam plasma concentrations ranging from 0.5 to 4.0 ng/mL. The blood level profile of flurazepam and its major metabolites was determined in man following the oral administration of 30 mg daily for 2 weeks. Both hydroxyethyl flurazepam (the major metabolite) and N-desalkyl flurazepam are active. The N-desalkyl metabolite is slowly excreted in the urine as the conjugated form. Because of the long half-life of this metabolite (47 to 100 hours), peak hypnotic effect of flurazepam may be reached after 2 to 3 nights of use.
INDICATIONS
Dalmane is a hypnotic agent useful for the treament of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings. Dalmane can be used effectly in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. Sleep laboratory studies have determined that Dalmane is effective for at least 28 consecutive nights of drug administration.
HOW DO FLURAZEPAM WORK?
Hynotics reduce the alertness of the brain which helps you get to sleep. GABA is a chemial messenger (or "neurotransmitter") in the brain and is the brain's own naturally occurring "calmer." The flurazepam make the action of GABA more powerful and this helps calm the brain down and help you get to sleep.
ADVERSE REACTIONS
Dizzness, drowsiness, light-headedness, staggering, ataxia
and falling have occurred, particularly in elderly or debilitated persons.
Severe sedation, disorientation and coma, probably because of drug intolerance
or overdosage, have been reported. Also reported were headache, heartburn,
upset stomach, nausea, vomiting, diarrhea, constipation, gastrointestinal
pain, nervousness, talkativeness, apprehension, irritability, weakness,
chest pains, body and joint pains.