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The most generally observed adverse events associated with the use of Ambien CR were headache (19%), somnolence (15%), and dizziness (12%) during treatment with Ambien CR at daily doses of up to 12.5 mg for 3 weeks.
3.5% of 201 patients receiving 6.25 mg or 12.5 mg of Ambien CR discontinued treatment because of an adverse event in clinical trials with Ambien CR. Events most commonly associated with discontinuation were somnolence (1.0%) and dizziness (1.0%).
Following are the adverse effects reported by at least 1% of patients treated with Ambien CR: • Infections and Infestations: Influenza, Gastroenteritis, Labyrinthitis (inflammation of the inner ear) • Metabolism and Nutrition Disorders: Appetite disorder • Psychiatric disorders: Hallucination, disorientation, anxiety, depression, psychomotor retardation, binge eating, depersonalization, disinhibition, euphoric mood, mood swings, stress symptoms • Nervous system disorders: headache, somnolence, dizziness, memory disorders, balance disorder, disturbance in attention, hypoesthesia, ataxia, paraesthesia • Eye disorders: visual disturbance, eye redness, blurred vision, altered visual depth perception, asthenopia • Ear and labyrinth disorders: vertigo, tinnitus • Respiratory, thoracic and mediastinal disorders: throat irritation • Gastrointestinal disorders: nausea, constipation, abdominal discomfort, abdominal tenderness, frequent bowel movements, gastroesophageal reflex disease, vomiting • Skin and subcutaneous tissue disorders: rash, skin wrinkling, urticaria • Musculoskeletal and connective tissue disorders: back pain, myalgia, neck pain • Reproductive system and breast disorders: menorrhagia • General disorders and administration site conditions: fatigue, asthenia, cheat discomfort • Investigations: increased blood pressure and body temperature • Injury, poisoning and procedural complications: contusion • Social circumstances: exposure to poisonous plant The adverse effects differ in the elderly patients though.
Recommended dose for elderly or debilitated patients, or patients with hepatic insufficiency is 6.25 mg, and they must be closely monitored. Ambien should be taken before going to bed and when about to sleep.