Adverse Findings Observed In Placebo-Controlled Trials
Adverse Events Resulting In Discontinuation Of Treatment
In placebo-controlled, parallel-group clinical trials in the elderly, 3.8% of 208 patients who received placebo, 2.3% of 215 patients who received 2 mg LUNESTA, and 1.4% of 72 patients who received 1 mg LUNESTA discontinued treatment due to an adverse event. In the 6-week parallel-group study in adults, no patients in the 3 mg arm discontinued because of an adverse event.
In the long-term 6-month study in adult insomnia patients, 7.2% of 195 patients who received placebo and 12.8% of 593 patients who received 3 mg LUNESTA discontinued due to an adverse event. No event that resulted in discontinuation occurred at a rate of greater than 2%.
Adverse Events Observed At An Incidence Of ≥2% In Controlled Trials
Table 1 shows the incidence of treatment-emergent adverse events from a Phase 3 placebocontrolled study of LUNESTA at doses of 2 or 3 mg in non-elderly adults. Treatment duration in this trial was 44 days. The table includes only events that occurred in 2% or more of patients treated with LUNESTA 2 mg or 3 mg in which the incidence in patients treated with LUNESTA was greater than the incidence in placebo-treated patients.
Table 1: Incidence (%) of Treatment-Emergent Adverse Events in a 6-Week Placebo-Controlled Study in Non-Elderly Adults with LUNESTA1
| Adverse Event | Placebo (n=99) | LUNESTA 2 mg (n=104) | LUNESTA 3 mg (n=105) |
| Body as a Whole | | | |
| Headache | 13 | 21 | 17 |
| Viral Infection | 1 | 3 | 3 |
| Digestive System | | | |
| Dry Mouth | 3 | 5 | 7 |
| Dyspepsia | 4 | 4 | 5 |
| Nausea | 4 | 5 | 4 |
| Vomiting | 1 | 3 | 0 |
| Nervous System | | | |
| Anxiety | 0 | 3 | 1 |
| Confusion | 0 | 0 | 3 |
| Depression | 0 | 4 | 1 |
| Dizziness | 4 | 5 | 7 |
| Hallucinations | 0 | 1 | 3 |
| Libido Decreased | 0 | 0 | 3 |
| Nervousness | 3 | 5 | 0 |
| Somnolence | 3 | 10 | 8 |
| Respiratory System | | | |
| Infection | 3 | 5 | 10 |
| Skin and Appendages | | | |
| Rash | 1 | 3 | 4 |
| Special Senses | | | |
| Unpleasant Taste | 3 | 17 | 34 |
| Urogenital System | | | |
| Dysmenorrhea * | 0 | 3 | 0 |
| Gynecomastia ** | 0 | 3 | 0 |
1 Events for which the LUNESTA incidence was equal to or less than placebo are not listed on
the table, but included the following: abnormal dreams, accidental injury, back pain,
diarrhea, flu syndrome, myalgia, pain, pharyngitis, and rhinitis.
* Gender-specific adverse event in females
** Gender-specific adverse event in males
Adverse events from Table 1 that suggest a dose-response relationship in adults include viral infection, dry mouth, dizziness, hallucinations, infection, rash, and unpleasant taste, with this relationship clearest for unpleasant taste.
Treatment duration in these trials was 14 days. The table includes only events that occurred in 2% or more of patients treated with LUNESTA 1 mg or 2 mg in which the incidence in patients treated with LUNESTA was greater than the incidence in placebo-treated patients.
These figures cannot be used to predict the incidence of adverse events in the course of usual medical practice because patient characteristics and other factors may differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.
The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contributions of drug and non-drug factors to the adverse event incidence rate in the population studied.
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