3.3.12 Psychiatric Effects
3.3.12.A Zolpidem Tartrate
3.3.12.A.1 Delirium
a) Zolpidem induced delirium with mania in a 67-year-old teacher with no significant psychiatric history who presented to the emergency room after 2 weeks of progressively worsening confusion, agitation, rapid speech, poor sleep, limited appetite, increased disorganization, and paranoid thoughts. Four days prior to hospitalization, she began to talk of the FBI following her and trying to harm her. Her affect was labile, agitated, and frightened and thoughts were tangential and a flight of ideas. The patient was taking zolpidem 10 milligrams (mg) at bedtime for the past 6 weeks since being discharged from the hospital after knee replacement surgery (Hill, Oberstar & Dunn, 2004).
b) Two and a half hours after receiving zolpidem 5 milligrams (mg), an 86-year-old woman, who had sustained a head trauma 1 month prior to admission, became restless and would not follow directions of the nursing staff. She climbed over the bed rails and walked with an unsteady gait. She was oriented to person but not to time or place. She was given haloperidol 5 mg intramuscularly and restrained. With haloperidol 0.5 mg every 12 hours for 2 days, her symptoms resolved. This patient, in addition to being elderly and female, had hypoalbuminemia. All 3 factors can contribute to unusually high serum concentrations of zolpidem (Brodeur & Stirling, 2001).
3.3.12.A.2 Depression, worsening
a) Worsening of depression, including suicidal ideation, has been observed in association with sedative or hypnotic use. This effect has occurred primarily in depressed patients; the onset of any new behavioral sign or symptom that is of concern should be immediately evaluated (Prod Info AMBIEN CR(TM) oral tablets , 2005).
3.3.12.A.3 Hallucinations
a) During a three-week clinical trial, hallucinations were reported in 4% of patients who received extended-release zolpidem (12.5 milligrams); the incidence was 0% in the placebo group (Prod Info AMBIEN CR(TM) oral tablets , 2005).
b) Three separate occurrences of visual HALLUCINATIONS are described in a 23- year-old healthy female patient who was prescribed zolpidem for insomnia. On each occasion, visual hallucinations occurred after a short course of drug (zolpidem 10 milligrams (mg) nightly for 3 weeks, 5 days, and 4 days). This was followed by approximately a 50-hour free period, after which a 10- milligram (mg) dose of zolpidem was taken for insomnia. Hallucinations described as objects in the room appearing different and larger than normal, appeared 10 to 30 minutes later. The patient decreased her dose to 5 mg and experienced no complications (Tsai et al, 2003).
c) Zolpidem-associated visual hallucinations were reported in 5 patients receiving zolpidem 5 to 20 milligrams (4 patients) and zolpidem 60 mg in the other (Elko et al, 1998j). Most had been taking the zolpidem for less than 1 week and all 5 were concomitantly using an antidepressant: sertraline, desipramine, fluoxetine, bupropion, or venlafaxine. Hallucinations lasted from 1 to 7 hours. The authors suggest that the hallucinations may have been due to an interaction between serotonin reuptake inhibition and zolpidem.
d) A psychotic reaction following a single dose of zolpidem 10 milligrams was reported (Iruela et al, 1993). The patient was a 20-year-old female with anorexia nervosa who experienced visual hallucinations and macropsia 20 minutes after taking the drug. She then slept for 7 hours and woke up complaining of a "hangover." Her level of consciousness was normal during the period of hallucinations and had a full recall of the events. Rechallenge with 5-milligram dose one week later produced a similar episode with less intensity. The validity of this case-report is in question since possible hypnagogic visual illusions and/or hallucinations may also occur in a dream state, not only in psychosis (Morselli, 1993).
3.3.12.A.4 Memory impairment
a) Incidence: 3%
b) During a three-week clinical trial, memory disorders, including amnesia, anterograde amnesia, and memory impairment, were reported in 3% of patients who received extended-release zolpidem (12.5 milligrams); the incidence was 0% in the placebo group (Prod Info AMBIEN CR(TM) oral tablets , 2005).
3.3.12.A.5 Psychotic disorder
a) A psychotic reaction following a single dose of zolpidem 10 milligrams was reported (Iruela et al, 1993). The patient was a 20-year-old female with anorexia nervosa who experienced visual hallucinations and macropsia 20 minutes after taking the drug. She then slept for 7 hours and woke up complaining of a "hangover." Her level of consciousness was normal during the period of hallucinations and had a full recall of the events. Rechallenge with 5-milligram dose one week later produced a similar episode with less intensity. The validity of this case-report is in question since possible hypnagogic visual illusions and/or hallucinations may also occur in a dream state, not only in psychosis (Morselli, 1993).
b) Two cases of zolpidem-induced psychosis have been reported in elderly women. The first was a 71-year-old woman who took zolpidem 20 mg on 2 occasions (Markowitz et al, 1997). Afterwards her husband reported that she saw people outside of the window and began talking nonsensically. She could not recall these events. The second was a 74-year-old woman who was given zolpidem 20 mg prior to a magnetic resonance imaging test (Pitner et al, 1997). Within 1 hour she began babbling incoherently and was confused. After 2 hours, she developed AUDITORY-VISUAL HALLUCINATIONS, DELUSIONS, and PSYCHOMOTOR AGITATION. This lasted for 3 hours.
3.3.12.A.6 Suicidal thoughts
a) Worsening of depression, including suicidal ideation, has been observed in association with sedative or hypnotic use. This effect has occurred primarily in depressed patients; the onset of any new behavioral sign or symptom that is of concern should be immediately evaluated (Prod Info AMBIEN CR(TM) oral tablets , 2005).
Last edited by good4nothing; 03-28-2007 at 11:01 PM.
No, the real point is, I don't give a damn
- Carl
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