Restoril (Temazepam) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

During controlled clinical studies in which 1076 patients received Restoril^® (temazepam) 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:

The following adverse events have been reported less frequently (0.5%-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%).

REPORTS OF SUSPECTED RESTORIL SIDE EFFECTS / ADVERSE REACTIONS

Possible Restoril side effects / adverse reactions in 48 year old male

Reported by a physician from United States on 2012-02-13

Patient: 48 year old male

Reactions: Completed Suicide

Adverse event resulted in: death

Suspect drug(s):
Lorazepam
    Administration route: Oral

Alprazolam
    Administration route: Oral

Restoril
    Administration route: Oral

Quetiapine
    Administration route: Oral

Possible Restoril side effects / adverse reactions in 77 year old male

Reported by a physician from United States on 2012-02-13

Patient: 77 year old male

Reactions: Completed Suicide

Adverse event resulted in: death

Suspect drug(s):
Restoril
    Administration route: Oral

Hydroxyzine
    Administration route: Oral

Escitalopram
    Administration route: Oral

Possible Restoril side effects / adverse reactions in 19 year old female

Reported by a physician from United States on 2012-02-13

Patient: 19 year old female

Reactions: Cardio-Respiratory Arrest, Completed Suicide

Adverse event resulted in: death

Suspect drug(s):
Venlafaxine
    Administration route: Oral

Restoril
    Administration route: Oral

Olanzapine
    Administration route: Oral