Sleep medicine
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Multicenter Study Comparative Study
Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy with cataplexy.
The benefit/risk ratio of modafinil was recently re-evaluated by the European Medicines Agency and was shown to be negative for idiopathic hypersomnia (IH) because of insufficient data. ⋯ Modafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy.
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Randomized Controlled Trial Multicenter Study
Evaluation of subjective efficacy and safety of ramelteon in Japanese subjects with chronic insomnia.
To assess patient-reported efficacy and safety of ramelteon in Japanese patients with chronic insomnia. ⋯ In Japanese adults with chronic insomnia, ramelteon 8 mg significantly reduced patient-reported sleep latency, increased total sleep time and improved sleep quality after 1 week of treatment. Ramelteon was generally well tolerated with no rebound insomnia.
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Randomized Controlled Trial Multicenter Study Comparative Study
A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome.
This study evaluated the dose-related efficacy and safety of pregabalin in patients with idiopathic restless legs syndrome (RLS). ⋯ In this 6-week phase 2b study, pregabalin reduced RLS symptoms in patients with moderate-to-severe idiopathic RLS. The symptom reduction at week 6 was dose-dependent with 123.9 mg/day providing 90% efficacy. Pregabalin was safe and well tolerated across the entire dosing range.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of pramipexole in Japanese patients with primary restless legs syndrome: A polysomnographic randomized, double-blind, placebo-controlled study.
To evaluate the efficacy of pramipexole on polysomnographic measures, patient ratings and a clinical rating in Japanese patients with primary restless legs syndrome (RLS). ⋯ Pramipexole is highly efficacious in the reduction of PLMI and in the improvement of subjective severity of RLS and subjective sleep disturbance caused by the disorder.
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Randomized Controlled Trial Multicenter Study
The partial positive allosteric GABA(A) receptor modulator EVT 201 is efficacious and safe in the treatment of adult primary insomnia patients.
To evaluate polysomnographic (PSG) and self-reported measures of the efficacy and safety of EVT 201 in patients with primary insomnia. ⋯ This first study of EVT 201 in adult patients with primary insomnia demonstrated improved measures of sleep onset and sleep maintenance, including during the third and fourth quarters of the night. Adverse events were infrequent and all were mild to moderate in severity.