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%).
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