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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO RESTORIL

Possible Restoril side effects / adverse reactions in 32 year old male

Reported by a individual with unspecified qualification from United States on 2007-01-25

Patient: 32 year old male

Reactions: Confusional State, Head Injury, Intentional Self-Injury, Fall, Loss of Consciousness, Abnormal Dreams, Mood Altered, Completed Suicide, Pulmonary Oedema, Brain Oedema, Depression, Adrenal Haemorrhage, Pupil Fixed, Hallucination, Nervousness, Oxygen Saturation Decreased, Mydriasis, Partner Stress, Amnesia, Anxiety, Emotional Distress, Visceral Congestion, Pneumoconiosis, Hypotonia, Heart Rate Increased, Bradycardia, GUN Shot Wound, Blood Pressure Decreased, Face Injury

Adverse event resulted in: death

Suspect drug(s):
Lorcet Plus Tablets 7.5/650 (Hydrocodone Bitartrate and Acetaminophen)
    Indication: Pain

Talwin NX
    Indication: Pain

Norco
    Indication: Pain

Vicodin
    Indication: Pain

Lortab
    Indication: Pain

Ambien
    Indication: Pain

Temazepam
    Indication: Pain

Dalmane
    Indication: Pain

Restoril
    Indication: Pain

Lidoderm
    Indication: Pain

Lidopain (Lidocaine)
    Indication: Pain

Other drugs received by patient: Zonegran; Proponapat (Nos)

Possible Restoril side effects / adverse reactions in 32 year old male

Reported by a consumer/non-health professional from United States on 2007-02-02

Patient: 32 year old male

Reactions: Pco2 Decreased, Confusional State, Base Excess Increased, Fall, Suicidal Ideation, Blood Calcium Decreased, Abnormal Dreams, Mood Altered, Completed Suicide, Pulmonary Oedema, Brain Oedema, Pupil Fixed, Depression, Hallucination, Blood Creatinine Increased, Blood Glucose Increased, Nervousness, Blood Alcohol Increased, Blood Chloride Decreased, Body Temperature Decreased, Blood Bicarbonate Decreased, Amnesia, Anxiety, Visual Disturbance, Blood Potassium Decreased, Heart Rate Increased, Bradycardia, GUN Shot Wound, Blood Pressure Decreased

Adverse event resulted in: death

Suspect drug(s):
Lorcet-HD
    Dosage: oral
    Administration route: Oral
    Indication: Pain
    Start date: 2003-01-01

Restoril
    Indication: Pain
    Start date: 2003-01-01

Lortab
    Indication: Pain
    Start date: 2003-01-01

Talwin Nx(naloxone Hdrochloride, Pentazocine Hydrochloride)
    Indication: Pain
    Start date: 2003-01-01

Ambien
    Indication: Back Pain
    Start date: 2003-01-01
    End date: 2004-09-20

Norco
    Indication: Pain
    Start date: 2003-01-01

Vicodin
    Indication: Pain
    Start date: 2003-01-01

Temazepam
    Indication: Pain
    Start date: 2003-01-01

Dalmane
    Indication: Pain
    Start date: 2003-01-01

Lidoderm
    Indication: Pain
    Start date: 2003-01-01

Lidocaine
    Indication: Pain
    Start date: 2003-01-01

Other drugs received by patient: Zonegran; Proponapat

Possible Restoril side effects / adverse reactions in 32 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-06

Patient: 32 year old male

Reactions: Pco2 Increased, Abnormal Dreams, Mood Altered, Pulmonary Oedema, Blood Creatinine Increased, Nervousness, Blood Chloride Increased, Body Temperature Decreased, Blood Bicarbonate Decreased, Hypotonia, GUN Shot Wound, Confusional State, Pco2 Decreased, Head Injury, Haemorrhage, Blood PH Decreased, Fall, Blood Calcium Decreased, PO2 Decreased, Completed Suicide, Brain Oedema, Depression, Adrenal Haemorrhage, Hallucination, Blood Glucose Increased, Amnesia, Anxiety, Visceral Congestion, Visual Disturbance, Blood Potassium Decreased, Heart Rate Increased, Bradycardia, PO2 Increased, Cardiac Arrest, Blood Pressure Decreased, Face Injury

Adverse event resulted in: death

Suspect drug(s):
Lorcet /00607101/
    Indication: Pain

Talwin NX
    Indication: Pain

Ambien
    Indication: Back Pain
    End date: 2004-09-20

Lortab
    Indication: Pain

Norco
    Indication: Pain

Vicodin
    Indication: Pain

Temazepam
    Indication: Pain

Flurazepam Hydrochloride
    Indication: Pain

Restoril
    Indication: Pain

Lidoderm
    Indication: Pain

Lidopain
    Indication: Pain

Other drugs received by patient: Zonegran; Proponapat