A prospective study examining patient satisfaction and sleep analysis data in drug therapy for patients with insomnia.

JRCT ID: jRCT1031210223

Registered date:05/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insomnia disorder
• Date of first enrollment: 12/08/2021
• Target sample size: 17
• Study type: Interventional
• Intervention(s): Take zolpidem tartrate tablets 5 mg (Mysley tablets or its generic products) once daily before bedtime for 8 weeks

Outcome(s)

• Primary Outcome: Evaluation of Athens Insomnia Scale at 8 weeks from the start of treatment

Secondary Outcome

CGI-I
Percentage of patients with AIS of less than 6 points at completion of clinical trial
medication after completion of clinical trial

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Insomnia disorder (ICSD-3)

Exclude criteria

1. Patients with Athens Insomnia Scale (AIS) at the getting consent or beginning of the trial less than 9 points.
2. Patients who have experienced drug treatment for insomnia within the past 14 days.
3. Patients without a sleeping diary since 7 days from the start of the trial, or Patients who do not need further improvement.
4. Patients suspected or suffering from the following diseases.
Mental illness
Sleep apnea syndrome
Sleep-related movement disorder
Central hypersomnia
Accompanying sleep
Circadian rhythm disturbance
alcoholism
drug addiction
cancer
immune disease
5. Pregnant women, lactating women
6. Patients who are engaged in jobs requiring driving such as automobiles or motorbikes or jobs involving danger or scheduled to participate during the trial participation period.

Related Information

• Primary Sponsor: Sone Masayoshi
• Secondary Sponsor: SUSMED, Inc