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SONATA (ZALEPLON): DRUG ABUSE AND DEPENDENCE

Controlled Substance Class

Sonata (Zaleplon) is classified as a Schedule IV controlled substance by federal regulation.

Abuse, Dependence, and Tolerance

Abuse

Two studies assessed the abuse liability of Zaleplon (Sonata) at doses of 25, 50, and 75 mg in subjects with known histories of sedative drug abuse. The results of these studies indicate that Sonata has an abuse potential similar to benzodiazepine and benzodiazepine-like hypnotics.

Dependence

The potential for developing physical dependence on Sonata (Zaleplon) capsules and a subsequent withdrawal syndrome was assessed in controlled studies of 14-, 28-, and 35-night durations and in open-label studies of 6- and 12-month durations by examining for the emergence of rebound insomnia following drug discontinuation. Some patients (mostly those treated with 20 mg) experienced a mild rebound insomnia on the first night following withdrawal that appeared to be resolved by the second night. The use of the Benzodiazepine Withdrawal Symptom Questionnaire and examination of any other withdrawal-emergent events did not detect any other evidence for a withdrawal syndrome following abrupt discontinuation of Zaleplon (Sonata) capsules therapy in pre-marketing studies.

However, available data cannot provide a reliable estimate of the incidence of dependence during treatment at recommended doses of Sonata. Other sedative/hypnotics have been associated with various signs and symptoms following abrupt discontinuation, ranging from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, sweating, vomiting, tremors, and convulsions. Seizures have been observed in two patients, one of which had a prior seizure, in clinical trials with Zaleplon. Seizures and death have been seen following the withdrawal of zaleplon from animals at doses many times higher than those proposed for human use. Because individuals with a history of addiction to, or abuse of, drugs or alcohol are at risk of habituation and dependence, they should be under careful surveillance when receiving Zaleplon (Sonata) or any other hypnotic.

Tolerance

Possible tolerance to the hypnotic effects of Sonata (Zaleplon) 10 and 20 mg was assessed by evaluating time to sleep onset for Zaleplon (Sonata) compared with placebo in two 28-night placebo-controlled studies and latency to persistent sleep in one 35-night placebo-controlled study where tolerance was evaluated on nights 29 and 30. No development of tolerance to Sonata was observed for time to sleep onset over 4 weeks.

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