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Restoril (Temazepam) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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%).



REPORTS OF SUSPECTED RESTORIL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Restoril. The information is not vetted and should not be considered as verified clinical evidence.

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



See index of all Restoril side effect reports >>

Drug label data at the top of this Page last updated: 2013-07-31

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