RESTORIL SIDE EFFECTS
- Generic Name: temazepam
- Brand Name: Restoril
- Drug Class: Sedatives, Anxiolytics, Benzodiazepines
Last updated on MDtodate: 10/10/2022
SIDE EFFECTS
During controlled clinical studies in which 1076 patients received Restoril at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table:
| Restoril % Incidence (n=1076) |
Placebo % Incidence (n=783) |
|
| Drowsiness | 9.1 | 5.6 |
| Headache | 8.5 | 9.1 |
| Fatigue | 4.8 | 4.7 |
| Nervousness | 4.6 | 8.2 |
| Lethargy | 4.5 | 3.4 |
| Dizziness | 4.5 | 3.3 |
| Nausea | 3.1 | 3.8 |
| Hangover | 2.5 | 1.1 |
| Anxiety | 2.0 | 1.5 |
| Depression | 1.7 | 1.8 |
| Dry Mouth | 1.7 | 2.2 |
| Diarrhea | 1.7 | 1.1 |
| Abdominal Discomfort | 1.5 | 1.9 |
| Euphoria | 1.5 | 0.4 |
| Weakness | 1.4 | 0.9 |
| Confusion | 1.3 | 0.5 |
| Blurred Vision | 1.3 | 1.3 |
| Nightmares | 1.2 | 1.7 |
| Vertigo | 1.2 | 0.8 |
The following adverse events have been reported less frequently (0.5% to 0.9%):
Central Nervous System – anorexia, ataxia, equilibrium loss, tremor, increased dreaming
Cardiovascular – dyspnea, palpitations
Gastrointestinal – vomiting
Musculoskeletal – backache
Special Senses – hyperhidrosis, burning eyes
Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).
SRC: NLM .