Insomnia Treatment and Health Care

Indiplon is a hypnotic-sedative non-benzodiazepine for short-term action.
It ‘an enhancer allosteric high affinity GABA-A.
It ‘been shown that Indiplon binds to specific binding sites for BZ1 or alpha1 receptor GABA-A, different from classical benzodiazepines.

A phase III study evaluated the efficacy and safety of Indiplon, formulation immediate release in 200 adult patients with primary insomnia chronic within 35 days.
Indiplon showed a statistically significant improvement knelled primary endpoint of Latency to Persistent Sleep (LPS), a measure obtained by polysomnography.
Treatment with Indiplon 10mg reduced LPS to 28 minutes (p <0.002) while the dose to 20mg has reduced to 27 minutes (p <0.05) compared to placebo (LPS 37 minutes), and the effect was sustained during the study.
There was no evidence of withdrawal effects when the drug was stopped, using the Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ).
There was no evidence insomnia rebound.

A second clinical trial phase III Indiplon immediate release showed the achievement of the primary end points and secondary in 593 patients with insomnia transient.

The primary end point was represented by Latency to Persistent sleep (LPS), while the secondary end point was in Latency to Sleep Onset (LSO).
The improvements mean knelled primary endpoint were 36% and 50% for the dose 10mg and 20mg, respectively.
Patients have also shown an improvement of Sleep Quality for both doses. (Xagena2006)

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