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Sonata (zaleplon) is indicated for the short-term treatment of insomnia. Sonata (zaleplon) has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings.
The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
DOSAGE AND ADMINISTRATION
The dose of Sonata (zaleplon) should be individualized. The recommended dose of Sonata (zaleplon) for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Sonata (zaleplon) appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Sonata (zaleplon) should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS.). Taking Sonata (zaleplon) with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Sonata (zaleplon) on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Sonata (zaleplon) . The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Sonata (zaleplon) 5 mg because clearance is reduced in this population. Sonata (zaleplon) is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Sonata (zaleplon) has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see DRUG INTERACTIONS under PRECAUTIONS).
Sonata (zaleplon) capsules are supplied as follows:
5 mg: opaque green cap and opaque pale green body with "5 mg" on the cap and "SONATA (zaleplon) " on the body.
NDC 60793-145-01.............................................................Bottles of 100
10 mg: opaque green cap and opaque light green body with "10 mg" on the cap and "SONATA (zaleplon) " on the body.
NDC 60793-146-01.............................................................Bottles of 100
Sonata® (zaleplon) is a registered trademark of King Pharmaceuticals Research and Development, Inc.
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F).
Dispense in a light-resistant container as defined in the USP.
Prescribing Information as of November 2007. Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101. FDA Rev date: 12/11/2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/2/2008
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