Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed.

Objectives: Appraise the evidence for daridorexant 50 mg and 25 mg versus placebo when treating chronic insomnia disorder in terms of number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH).

Methods: NNT, NNH, and LHH were calculated from a 3-month pivotal Phase 3 study ( = 930; randomized 1:1:1 to daridorexant 50 mg, daridorexant 25 mg, or placebo once nightly). Wakefulness after sleep onset, latency to persistent sleep, self-reported total sleep time, Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), and Insomnia Severity Index were used for the NNT efficacy analysis.

The Associations between Insomnia Severity and Health Outcomes in the United States.

Little is known about the associations between insomnia severity, insomnia symptoms, and key health outcomes. Using 2020 United States National Health and Wellness Survey (NHWS) data, we conducted a retrospective, cross-sectional analysis to determine the associations between insomnia severity and a number of health outcomes germane to patients (health-related quality of life (HRQoL), employers and government (workplace productivity), and healthcare payers (healthcare resource utilization (HCRU)). The Insomnia Severity Index (ISI) questionnaire was used to evaluate overall insomnia severity.

Psychometric evaluation of the Stanford Sleepiness Scale.

Two assumptions underlying the Stanford Sleepiness Scale (SSS) were evaluated: that the descriptors defining each level of the scale are equivalent ways of characterizing a particular level of sleepiness; and that sleepiness, thus measured, is an unidimensional construct. Twenty-four True/False items were derived from the descriptors at each level of the SSS. This revised scale was administered to 340 undergraduates in a questionnaire which also included: the SSS; four visual analogue scales; items identifying the subject's age, sex, and circadian type; and the time of administration.

The effects of cyclobenzaprine on sleep physiology and symptoms in patients with fibromyalgia.

A double blind, placebo controlled, crossover design study examined overnight sleep physiology, pain, fatigue, and mood symptoms in 12 patients with fibromyalgia treated with cyclobenzaprine. Nine patients completed the study. Patients receiving cyclobenzaprine showed a decrease in evening fatigue (F = 4.

Sleep and symptoms in fibrositis syndrome after a febrile illness.

Sleep physiology and symptoms of 9 patients with fibrositis syndrome secondary to a febrile illness were compared to 9 patients with fibrositis syndrome who did not attribute their symptoms to a febrile illness and to 10 healthy controls. Both patient groups showed an alpha EEG (7.5 to 11 Hz) nonrapid eye movement sleep anomaly, had similar observed tender points, and self-ratings of musculoskeletal pain.

Sleep and morning pain in primary osteoarthritis.

Sleep physiology, pain and mood symptoms of 8 patients with idiopathic osteoarthritis of the hands who complained of morning symptoms were compared to 7 age and sex matched subjects with similar joint pathology, but who did not complain of morning symptoms. The "AM Symptoms" group had sleep related (nocturnal) myoclonus, associated with increased morning peripheral joint tenderness and decreased grip strength, whereas the "No Complaint" group had improved mood in the morning.

Treatment of chronic insomnia by restriction of time in bed.

A treatment of chronic insomnia is described that is based on the recognition that excessive time spent in bed is one of the important factors that perpetuates insomnia. Thirty-five patients, with a mean age of 46 years and a mean history of insomnia of 15.4 years, were treated initially by marked restriction of time available for sleep, followed by an extension of time in bed contingent upon improved sleep efficiency.

Sleep and posttraumatic rheumatic pain modulation disorder (fibrositis syndrome).

The clinical features and sleep physiology of 11 female patients with "fibrositis syndrome" or rheumatic pain modulation disorder (RPMD) were compared with 11 female postaccident pain (PAP) patients who complained of widespread musculoskeletal pain, fatigue, and nonrestorative sleep following a nonphysically injurious motor vehicle or work-related accident. Both groups had similar musculoskeletal pain, fatigue, sleepiness and an alpha (7.5-11 Hz) EEG non-rapid eye movement (NREM) sleep anomaly.

Periodic movements in sleep and sleep-wake complaint.

Periodic movements during sleep (PMS) are frequent, involuntary movements, usually of the lower extremities, that disrupt sleep. Twelve patients (nine men and three women, mean age 53.9 years) with a complaint of persistent insomnia (DIMS) were compared with 11 patients (eight men and three women, mean age 53.