From the Guidelines
Insomnia is diagnosed when a person has difficulty falling asleep, staying asleep, or experiences non-restorative sleep despite adequate opportunity for sleep, along with daytime impairment related to the sleep disturbance, occurring at least 3 nights per week for at least 3 months, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) 1. The diagnostic criteria for insomnia require that these sleep difficulties cause clinically significant distress or impairment in social, occupational, or other important areas of functioning, and cannot be better explained by another sleep disorder, mental disorder, medical condition, medication effect, or substance use.
- Insomnia is further classified as sleep-onset insomnia (difficulty falling asleep), sleep-maintenance insomnia (difficulty staying asleep), or early-morning awakening insomnia.
- Diagnosis typically involves a comprehensive sleep history, sleep diaries for 1-2 weeks, and sometimes sleep studies to rule out other disorders like sleep apnea, as recommended by the American College of Physicians 1.
- The persistent nature of insomnia distinguishes it from transient sleep difficulties that many people experience occasionally due to stress or environmental factors, with duration ranging from 1 to 20 years across longitudinal studies 1.
- This chronic pattern of sleep disruption leads to the neurobiological changes that perpetuate the condition, including hyperarousal and conditioned sleep difficulty, affecting approximately 6% to 10% of adults who meet the diagnostic criteria for insomnia disorder 1.
From the FDA Drug Label
Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IV™) The diagnostic criteria for insomnia is not explicitly stated in the drug label, but it mentions that the studies were conducted on patients with chronic insomnia, which is defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IV™ 2.
- The label does not provide the specific diagnostic criteria for insomnia.
From the Research
Diagnostic Criteria for Insomnia
The diagnostic criteria for insomnia include:
- Difficulty initiating or maintaining sleep
- Inability to sleep despite having adequate opportunities
- Having negative daytime effects due to lack of sleep
- Sleep difficulty not explained by other disorder - with symptoms at least three times per week during a period of 3 months 3
Key Components of Insomnia Diagnosis
Insomnia can be diagnosed based on the following key components:
- Difficulty initiating sleep
- Difficulty maintaining sleep
- Wakefulness after sleep
- Sleep efficiency
- Sleep quality 4, 5
Prevalence of Insomnia
Insomnia is a prevalent sleep disorder, occurring in:
- Approximately 6-10% of the population 6
- As much as 30% of the general adult population 5
- About 7% to 18% of adults meet the criteria for an insomnia disorder 7
Treatment Options for Insomnia
Treatment options for insomnia include: