HALCION SIDE EFFECTS

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections:

• Risks from Concomitant Use with Opioids.
• Abuse, Misuse, and Addiction.
• Dependence and Withdrawal Reactions.
• Persistent or Worsening Insomnia.
• “Sleep-driving” and Other Complex Behaviors.
• Central Nervous System Manifestations.
• Effects on Driving and Operating Heavy Machinery.
• Patients with Depression.
• Compromised Respiratory Function.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidences cited below are estimates of clinical reactions among 1003 subjects who participated in the short term (duration of 1 to 42 days) placebo-controlled clinical trials of Halcion.

Adverse reactions leading to discontinuation in two multi-dose placebo controlled clinical trials include coordination disorders, drowsiness, grogginess, somnolence, depression, restlessness, dizziness, lightheadedness, headache, nausea, visual disturbance, nervousness, abdominal distress, bladder trouble, aching limbs, backache, and blepharitis.

Table 1: Common Adverse Drug Reactions in 1% or More of Halcion-Treated Subjects (and Greater than Placebo) Reported in Placebo-Controlled Clinical Trials

In addition to the common reactions enumerated above in Table1, the following adverse reactions have been reported at an incidence of 0.9% to 0.5%: euphoria, tachycardia, tiredness, confusional states/memory impairment, cramps/pain, depression, and visual disturbances.

Adverse reactions reported at an incidence less than 0.5% include: constipation, taste alterations, diarrhea, dry mouth, dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia, tinnitus, dysesthesia, weakness, congestion, and death from hepatic failure in a patient also receiving diuretic drugs.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Halcion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General disorders and administration site conditions: Paradoxical drug reaction, chest pain and fatigue

Gastrointestinal disorders: Tongue discomfort, glossitis, stomatitis

Hepatobiliary disorders: Jaundice

Injury, poisoning and procedural complications: Fall

Metabolism and nutrition disorders: Anorexia

Nervous system disorders: Anterograde amnesia, altered state of consciousness, dystonia, sedation, syncope, dysarthria and muscle spasticity

Psychiatric disorders: Confusional state (disorientation, derealisation, depersonalization), mania, agitation, restlessness, irritability, sleep disorder and libido disorder, hallucination, delusion, aggression, somnambulism, and abnormal behavior

Renal and urinary disorders: Urinary retention and urinary incontinence

Reproductive system and breast disorders: Menstruation irregular

Skin and subcutaneous tissue disorders: Pruritis

SRC: NLM .