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However, the majority of these adverse events were rated as either mild or moderate in severity. The rates of these particular adverse events are presented in the table below according to severity. Preferred Term (N) Mild n % Moderate n % Severe n %. Sedation (240) 63 26 118 49 59 25 Fatigue (74) 23 31 31 42 20 27 Somnolence (122) 49 40 57 47 16 13 Irritablity (62) 27 44 21 34 14 23 Headache (118) 57 48 49 42 12 10 Drug Discontinuation Phase The most common adverse events are summarized according to severity in the table below.

Overall, 348 subjects in the alprazolam XR group and 178 subjects in the placebo group had at least 1 adverse event with a severity rating recorded.

The percentages of subjects in the treatment groups reporting at least 1 adverse event bobbie com online order phentermine site of mild severity were 69.5% bobbie com online order phentermine site and 74.7%, respectively; rates with moderate severity were 77.0%, 87 and 68.5%, respectively, and rates with severe adverse events were 41.1% and 26.4%, respectively. The 5 most frequent severe discontinuation-emergent adverse events were nervousness 39/348 (11.2%), insomnia 35/348 (10.1%), headache 25/348 (7.2%), dizziness 21/348 (6.0%), and tremor 21/348 (6.0%). However, bobbie com online order phentermine site the majority of these adverse events were either mild or moderate in maximum severity.

Mild Moderate Severe Preferred Term (N) n % n % n % Nervousness (91) 20 22 32 35 39 43 Insomnia (102) 19 19 48 47 35 34 Headache (111) 27 24 59 53' 25 23 Dizziness (114) 38 33 55 48 21 18 Tremor (119) 43 38 55 48 21 18 F-5 Drug Discontinuation and Withdrawal Phenomena Discontinuation Phase in Placebo-Controlled Studies Over three-fourths of the subjects who participated in the treatment phase also participated in the discontinuation phase.

There were no differences in the demographic characteristics of the subjects in the treatment and discontinuation phases. In the alprazolam XR group, 348/422 (82.5%) subjects had at least 1 discontinuation- emergent adverse event, compared with 180/261 (69.0%) in the placebo group. As showm in the table below, the discount phentermine no prescription needed incidence of discontinuation-emergent adverse events in the alprazolam XR group was highest for neuropsychiatric (72.8%) and CNS (69.6%) adverse events. For subjects treated with placebo, the incidences of such discontinuation- emergent adverse events were 29.9% and 28.3%, respectively.

The following discontinuation-emergent adverse events occurred at rates which were >_5% and twice that observed in the placebo group: tremor (28.2%), dizziness (27%), headache (26.5%), insomnia (24.2%), order phentermine mastercard nervousness (21.8%), diarrhea (12.1%), depression (10.9%), decreased appetite (9.5%), hyperventilation (8.5%), derealization (8.1%), anxiety (7.8%), hypoesthesia (7.8%), muscle bobbie com online order phentermine site twitching (7.4%), paresthesia (7.1%), depersonalization (5.7%), and hot flushes (5.9%).

Discontinuation-Emergent Adverse Events in Placebo-Controlled Trials with Alprazolam XR OAE rate > 5% and twice the rate in Placebo Group) System Organ Class/ L Adverse Event Percentage of Subjects Reporting Adverse Event XANAX XR (n=422) Placebo (n=261) Nervous System Disorders Percentages (%) Tremor 28.2 10.7 Dizziness 27.0 unspecified . Headache 1 26.5 12.6 Hypoesthesia 7.8 2.3 Paresthesia 7.1 2.7 Psychiatric Disorders Insomnia 24.2 9.6 Nervousness 21.8 8.8 Depression 10.9 5.0 Derealization 8.0 3.8 Anxiety 7.8 2.7 Gastrointestinal Disorders Diarrhea 12.1 3.1 Respiratory Disorders Hyperventilation 8.5 2.7 Metabolism and Nutrition Disorders Appetite Decreased 9.5 3.8 Musculoskeletal Disorders Muscle Twitching 7.4 2.7 Vascular Disorders Hot Flushes 5.9 2.7 F-6 Abuse Liability of Alprazolam XR Studies examining abuse liability of alprazolam, in subjects with a history of sedative drug abuse, compared the abuse potential of alprazolam XR with those of alprazolam IR, several benzodiazepines, and placebo. On the euphoria scale, alprazolam XR produced significantly less euphoric effect than alprazolam IR or diazepam.



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